CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 51

Part 1 of 16 Abbott Aesku Alfa Wassermann Diagnostic Technologies

US Marketing Core Diagnostics ats@[Link] [Link]@[Link] info@[Link]
forMID– and HIGH–VOLUME Abbott Park, IL Des Plaines, IL West Caldwell, NJ
LABORATORIES 800-323-9100 [Link] 844-544-5044 [Link] 800-220-4488 [Link]
Name of instrument Alinity ci-series HELIOS HTC ACE Axcel
Type of instrument combination chemistry/immunoassay immunoassay chemistry
Operational type/Model type batch, random access, continuous random access, batch/benchtop batch, random access, continuous random access, discrete/
discrete/floor standing benchtop
List price/First year sold in U.S. —/2018 $175,000/2017 $34,500/2012
Targeted hospital bed size/Targeted test volume all/— 200–1,000/daily: > 25; monthly: > 500; annual: > 5,000 —/daily: ~15–50 comprehensive metabolic panels and lipids
Company manufactures instrument yes yes yes (also sold by McKesson, Henry Schein, Medline, AvMedical)
Other models in this family of analyzers — HELMED, HELIA ACE Alera
No. of units in clinical use in U.S./Outside U.S. (countries) ~2,200/~13,000 (154 countries) > 30/> 400 (Europe, North America, South America, Asia, —
Africa, Australia)
Dimensions (H × W × D)/Instrument footprint 4.4 × 3.9 × 3.84 for standalone module; up to 4.4 × 11.81 22.5 × 25.6 × 29.6 in./5.25 sq. ft. 33 × 28 × 26 in./10 sq. ft.
× 3.84 for 4-module system/14.98–45.31 sq. ft. for 1- to
4-module system
Weight empty/Weight fully loaded chem: 1,556 lbs.; immuno: 1,371 lbs./— 73 lbs./— 150 lbs./150 lbs.
No. of different measured assays onboard simultaneously chem: up to 280 (up to 280 can be run and calibrated at 4 (4 can be run and calibrated at one time) 40 (200 can be run and calibrated at one time)
one time); immuno: up to 188 (up to 188 can be run and
calibrated at one time)
No. of user-definable (open chemistry) channels 10 (10 can be active simultaneously) — 15 (15 can be active simultaneously)
Test throughput per hour/Assay run time up to 5,400 for Alinity c 4-module system; up to 800 for — 165/—
Alinity i 4-module system/depends on configuration
Chemistry:
No. of direct ion-selective electrode channels 3 — 3
Detection methods photometry, potentiometry — photometry, potentiometry, turbidimetric homogeneous
enzyme immunoassay
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — 4 min./35 specimens per hr.
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample < 30 sec. — 10 sec.
Immunoassay:
Fully automated microplate immunoassay system no — —
Methodologies supported chemiluminescence fluorescence, indirect fluorescent antibody —
Separation methodologies magnetic particle coated IFA slide —
Stat time until completion of a ß-hCG test — — —
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type up to 1,500 (chem), up to 600 (immuno)/self-contained multiuse 120/— 30–900/closed reagent system with open reagent channels
Reagents refrigerated onboard/Reagents ready to use yes (2°–10°C [chemistry], 2°–12°C [immunoassay])/yes no/yes yes (10°–14°C)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/no yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (closed reagent system)/no liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/yes no/no
Walkaway capability/Walkaway duration yes/240 min. or up to 600 specimens (150 specimens per module) yes/190 specimens or 240 tests yes/75 min. or 75 specimens or 248 tests
Design of sample-handling system 6-position rack rack ring
Uses washable cuvettes/Uses disposable cuvettes chem: yes/immuno: yes (can store up to 1,000 cuvettes) no/no no/yes (can store up to 248 cuvettes)
Min.–max. sample volume that can be aspirated at one time 1.5–35 µL (chemistry), 2–200 µL (immunoassay) — 3–200 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 80 µL/assay dependent/50 µL —/assay dependent/tube dependent 150 µL/53 µL/50 µL
Dedicated pediatric sample cup no no no
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (10–16.1 × 72–102 mm) yes/yes (11–16 × 55–100 mm) —
tube sizes
Pierces caps on primary tubes no no yes
Protects against probe collision yes yes no
Detects clots/liquid level/short sample yes/yes/yes no/yes/yes no/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots; quantitation hemolysis, icterus, lipemia, clots not available hemolysis, icterus, lipemia, clots not available
for hemolysis, icterus, lipemia
Dilutes patient samples onboard/Susceptibility to carryover yes/≤ 0.1 parts per million yes/no carryover yes (can be programmed to perform dilutions prior to analysis)/—
Automatic rerun capability yes no yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range — yes no
low results
Analyzer requires dedicated water supply yes (27 L/hr. consumption during operation for chemistry, no no
<10 L/hr. for immunoassay)
Autocalibration/Multipoint calibration supported yes (calibrants are stored onboard)/yes no (calibrants are not stored onboard)/— yes (calibrants are not stored onboard)/yes
Typical calibration frequency for ISE/therapeutic drugs/ 1 day/new lot or 7–45 days/new lot or 13 days/new lot or 30 — 3 hrs./—/—/30 days/—
drugs of abuse/general chemistries/immunoassays days/new lot or 30 days
Automatic programmable start/Automatic programmable shutdown —/no no/no no/no
Onboard real-time QC/Onboard software capability to review QC yes/yes no/yes yes/yes
Supports multiple QC lot numbers per analyte yes — yes
Waste management automated collection onboard instrument or direct to drain — automated collection onboard instrument
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, UPC, Code 39, Code 128, Matrix 2/5, yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes
Code 11, EAN/JAN, more)/yes
Lab can control analyzer from remote computer yes yes no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) — yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes no
UPS backup power supply yes yes no
Data-management capability/LIS or EHR systems interfaced onboard/— optional add-on ([Link])/Sunquest, Orchard onboard/CGM LabDaq, Orchard, CGM SchuyLab, LabTrak, more
LIS interface provided/Bidirectional interface capability no/yes (broadcast download and host query) no/yes (host query) no/yes (host query)
Modem servicing provided/Service engineer on-site response time —/based on contract no/— yes/24 hrs.
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 240 days (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 0 (chem and immuno); weekly: 30 min. (chem), 16 min. daily: 5 min.; weekly: 20 min. daily: 15 min.; weekly: 20–30 min.; monthly: 30–40 min.
(immuno); monthly: 2 min. (chem), 0 (immuno)
Maintenance records kept onboard for user/vendor some records (includes audit trail of who replaced parts)/no no/no yes (includes audit trail of who replaced parts)/no
Maintenance training demonstration module onboard yes no no
Training included with purchase/Avg. time for basic user training yes (2 training slots)/12 hrs. (at customer site) yes (1 training slot)/— yes (1 training slot)/4.5 days (at customer and vendor sites
[depends on sales agreement])
Advanced operator training/Extra charge for follow-up yes (at customer or vendor site)/yes yes/— no/—
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (varies by contract)/varies by contract yes (1 year)/— yes (1 year)/—
Distinguishing features (supplied by company) • compact, flexible, and scalable up to four modules and 14 • provides all-in-one IFA ANA, ANCA, and nDNA slide • self-contained analyzer, closed-tube sampling, stat interrupt
configurations processing and reading on one instrument capability; onboard sample, reagent refrigeration; ready-to-use
• harmonized family of systems across key lab disciplines • FDA cleared to identify seven HEp-2 patterns plus negative reagents, onboard reagent inventory management
leading to easier cross-training for lab staff results • integrated ISE module; no external water source or waste
Note: a dash in lieu of an answer means company • broad menu of high-quality assays aligned to CLSI • utilizes pattern-recognition software and can estimate the drainage
did not answer question or question is not applicable guidelines endpoint titer • new vitamin D test provides results in 10 minutes

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
52 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 2 of 16 Arlington Scientific Awareness Technology Beckman Coulter

Mike Ladow mladow@[Link] Rafael Castillo rcastillo@[Link] Doug Lee dylee@[Link]
forMID– and HIGH–VOLUME Springville, UT Palm City, FL Brea, CA
LABORATORIES 800-654-0146 [Link] 772-283-6540 [Link] 800-526-3821 [Link]
Name of instrument ASI Evolution RPR Syphilis Analyzer ChemWell 2 AU 5800
Type of instrument immunoassay immunoassay chemistry
Operational type/Model type batch/benchtop batch/benchtop continuous random access/floor standing
List price/First year sold in U.S. $50,995/2018 $40,000/2020 —/2011
Targeted hospital bed size/Targeted test volume —/daily: 100; monthly: 3,100; annual: 37,200 50/— —/annual: ≥ 1.5 million
Company manufactures instrument yes (also sold by Fisher Scientific, Cardinal, McKesson, VWR) yes (also sold by Monobind, GMI, IDE, others) yes (also sold by McKesson, Henry Schein, Medline,
Thermo Fisher Scientific)
Other models in this family of analyzers — ChemWell Fusion 4800 DxC 700 AU, AU480
No. of units in clinical use in U.S./Outside U.S. (countries) 141/10 —/80 (Colombia, Qatar, Ghana, Panama, Peru, UAE, Jamaica, —
Israel, Bolivia, Austria, more)
Dimensions (H × W × D)/Instrument footprint 19 × 36 × 22 in./6 sq. ft. 23 × 42 × 25 in./7 sq. ft. 50 × 168 × 62 in./72 sq. ft.
Weight empty/Weight fully loaded 78 lbs./— 133 lbs./160 lbs. 2,300–6,375 lbs. (model dependent)/—
No. of different measured assays onboard simultaneously 1 (1 can be run and calibrated at one time) up to 10 (4 can be run and calibrated at one time) 54–216 (54–216 can be run and calibrated at one time)
(model dependent)
No. of user-definable (open chemistry) channels 0 — 18 (76 can be active simultaneously)
Test throughput per hour/Assay run time 190/9–11 min. (avg. 10 min.) 2 (assay dependent)/— 2,000–9,800/8 min. 30 sec.
Chemistry:
No. of direct ion-selective electrode channels — — 3
Detection methods — — photometry, potentiometry
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — 4.5 min./model dependent
• Basic metabolic panel — — 12.5 min./model dependent
• Complete metabolic panel — — 14.5 min./model dependent
Typical time delay from ordering stat test until aspiration of sample — — 1 min.
Immunoassay:
Fully automated microplate immunoassay system yes (192 tests per unit; 48 wells per microplate) yes (96 wells per microplate) —
Methodologies supported agglutination, flocculation chemiluminescence, enzyme immunoassay —
Separation methodologies none necessary centrifugation, coated microwell —
Stat time until completion of a ß-hCG test — assay dependent —
• Typical time delay from test order to aspiration of sample — assay dependent —
Stat time until completion of a cTn test — assay dependent —
• Typical time delay from test order to aspiration of sample — assay dependent —
Approximate No. of tests per reagent set/Reagent type 480/self-contained multiuse 96/open reagent system 200–6,000 (varies by assay)/self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use no/yes no (37°C)/yes yes (4°–12°C)/yes
Reagent lot tracking/Reagent inventory yes/no yes/no yes/yes
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/62 min. or 192 specimens or 192 tests yes/120 min. or 96 specimens or 5 tests yes/400 specimens
Design of sample-handling system rack rack rack
Uses washable cuvettes/Uses disposable cuvettes no/— yes (can store up to 192 cuvettes)/no yes/no
Min.–max. sample volume that can be aspirated at one time 2–500 µL 5–300 µL 1–25 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 110 µL/300 µL/150 µL 200 µL/5 µL/< 5 µL 120 µL/41 µL or 1 µL with 4 mm above gel barrier/50 µL
Dedicated pediatric sample cup no no yes (dead volume: 50 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/no yes/no yes/yes (primary, secondary tubes: 11.5–16 × 55–102 mm;
tube sizes nested micro cups)
Pierces caps on primary tubes no no no
Protects against probe collision yes yes yes
Detects clots/liquid level/short sample yes/yes/yes no/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available detection for clots detection and quantitation for hemolysis, icterus, lipemia, clots
Dilutes patient samples onboard/Susceptibility to carryover yes/no yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to
analysis)/— analysis)/0.001 parts per million
Automatic rerun capability no no yes
Sample volume can be diluted to rerun out-of-linear-range high results no no yes
Sample volume can be concentrated to rerun out-of-linear-range no no yes
low results
Analyzer requires dedicated water supply no (0.03 L/hr. consumption during operation) no yes (62–248 L/hr. consumption during operation) (model
dependent)
Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/no no (calibrants are not stored onboard)/yes (recommended yes (calibrants are not stored onboard)/yes (recommended
avg. frequency: assay dependent) avg. frequency: assay dependent)
Typical calibration frequency for ISE/therapeutic drugs/ — —/—/—/—/assay dependent 1 day/14 days/14–20 days/30 days/—
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no no (< 5 min. warm-up time)/— yes (90 sec. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/no yes/yes yes/yes
Supports multiple QC lot numbers per analyte no yes yes
Waste management manually by user manually by user or direct to drain direct to drain
Sample barcode-reading capability/Autodiscrimination yes (UPC, Code 39, Code 128)/yes yes (Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer no no yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply no no yes
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/— onboard/Cerner, Antrim, CCA, Chemware, Dawning
Technologies, SCC, Dynamic Healthcare, Antek, more
LIS interface provided/Bidirectional interface capability no/no no/yes (host query) yes (included in instrument price)/yes (broadcast download
and host query)
Modem servicing provided/Service engineer on-site response time no/48 hrs. no/72 hrs. yes/within 24 hrs.
Mean time between failures 365 days (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 1.2 down service calls per year (displays error codes for
troubleshooting)
Average scheduled maintenance time by lab personnel daily: 10 min.; weekly: 10 min.; monthly: 10 min. daily: 15 min.; weekly: 30 min.; monthly: 30 min. daily: 8 min.; weekly: 15 min.; monthly: 45 min.
Maintenance records kept onboard for user/vendor no/no some records (self tests, calibrations, logs)/some records yes/no
(logs)
Maintenance training demonstration module onboard no no yes
Training included with purchase/Avg. time for basic user training yes (2 training slots)/0.5 days (at customer site) yes (4 training slots)/2 days (at customer site) yes (2 training slots)/3 days (combination of vendor and customer
sites; includes vendor training and in-lab operator training)
Advanced operator training/Extra charge for follow-up no/yes yes (at customer site)/yes (contract dependent) yes (at vendor site)/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year limited, service contract required)/varies by tier yes (1 year)/contract dependent yes (1 year)/—
of service
Distinguishing features (supplied by company) • low-cost, automated syphilis test 510(k) cleared for • fully customizable flexible software/firmware; remote • standardization across the AU family of chemistry analyzers
diagnostic, blood donor, and cadaveric screening access for troubleshooting • lower total cost of ownership due to fewer consumables
• can provide dilutions up to 1:2048 • fully customizable sample and reagent racks and concentrated reagents
Note: a dash in lieu of an answer means company • 92 percent hands-on time savings compared with manual • affordable analyzer; open ELISA/chemiluminescence • most common parts can be changed in three steps in less
did not answer question or question is not applicable RPR testing system with more than 50 tests currently programmed than 60 seconds and without tools

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 53

Part 3 of 16 Beckman Coulter Beckman Coulter Beckman Coulter

Doug Lee dylee@[Link] Doug Lee dylee@[Link] Doug Lee dylee@[Link]
forMID– and HIGH–VOLUME Brea, CA Brea, CA Brea, CA
LABORATORIES 800-526-3821 [Link] 800-526-3821 [Link] 800-526-3821 [Link]
Name of instrument DxC 700 AU DxI 9000 Access Immunoassay Analyzer Unicel DxI 600
Type of instrument chemistry immunoassay immunoassay
Operational type/Model type continuous random access/floor standing continuous random access/floor standing continuous random access/floor standing
List price/First year sold in U.S. —/2016 —/2023 —/2006
Targeted hospital bed size/Targeted test volume —/annual: 500,000–1.5 million — —
Company manufactures instrument yes (also sold by McKesson, Henry Schein, Medline, yes (also sold by McKesson, Henry Schein, Medline, yes (also sold by McKesson, Henry Schein, Medline,
Thermo Fisher Scientific) Thermo Fisher Scientific) Thermo Fisher Scientific)
Other models in this family of analyzers AU480, AU 5800 Access 2, Unicel DxI 600, Unicel DxI 800 Access 2, Unicel DxI 800
No. of units in clinical use in U.S./Outside U.S. (countries) — — —
Dimensions (H × W × D)/Instrument footprint 51 × 78 × 41 in./40.1 sq. ft. 63 × 79 × 41 in./22.5 sq. ft. 67 × 61.5 × 37.5 in./16 sq. ft.
Weight empty/Weight fully loaded 1,046 lbs./— 1,785 lbs./— 1,065 lbs./—
No. of different measured assays onboard simultaneously 63 (63 can be run and calibrated at one time) 50 (50 can be run and calibrated at one time) 50 (50 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 18 (120 can be active simultaneously) 0 0
Test throughput per hour/Assay run time 1,200 (800 photometric, 400 ISE tests in throughput)/8 min. 30 sec. up to 450/8–50 min. up to 200/13–55 min.
Chemistry:
No. of direct ion-selective electrode channels 3 — —
Detection methods photometry, potentiometry — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode 4.5 min./400 specimens per hr. — —
• Basic metabolic panel 12.5 min./133 specimens per hr. — —
• Complete metabolic panel 14.5 min./72 specimens per hr. — —
Typical time delay from ordering stat test until aspiration of sample 1 min. — —
Immunoassay:
Fully automated microplate immunoassay system — no no
Methodologies supported — chemiluminescence chemiluminescence
Separation methodologies — magnetic particle magnetic particle
Stat time until completion of a ß-hCG test — 10 min. 15 min.
• Typical time delay from test order to aspiration of sample — 16 sec. 18 sec.
Stat time until completion of a cTn test — 12 min. 17 min.
• Typical time delay from test order to aspiration of sample — 16 sec. 18 sec.
Approximate No. of tests per reagent set/Reagent type 200–2,000 (varies by assay)/self-contained multiuse 50, 100, or 200 per kit/self-contained multiuse 50 per pack or 100 per kit/self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use yes (4°–12°C)/yes yes (4°–10°C)/yes yes (4°–10°C)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/yes no/no
Walkaway capability/Walkaway duration yes/2 hrs. avg. or 150 specimens or 7,200 tests yes/240 min. or 140 specimens yes/180 min. or 60 specimens
Design of sample-handling system rack rack or direct track sampling when connected to automation rack
Uses washable cuvettes/Uses disposable cuvettes yes/no no/yes no/yes (can store > 1,000 cuvettes)
Min.–max. sample volume that can be aspirated at one time 1–25 µL 2–200 µL 5–200 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 120 µL/41 µL or 1 µL with 4 mm above gel barrier/40 µL or 10 µL/150 µL/80 µL 10 µL/150 µL/140 µL
4 mm above gel barrier
Dedicated pediatric sample cup yes (dead volume: 50 μL) yes (dead volume: 150 µL) yes (dead volume: 100 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (primary, secondary tubes: 11.5–16 × 55–102 mm; yes/no yes/—
tube sizes nested micro cups)
Pierces caps on primary tubes no no no
Protects against probe collision yes no no
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection and quantitation for hemolysis, icterus, lipemia, clots hemolysis, icterus, lipemia, clots not available detection for clots; hemolysis, icterus, lipemia not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to
analysis)/0.001 parts per million analysis)/— analysis)/—
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes no no
low results
Analyzer requires dedicated water supply yes (28 L/hr. consumption during operation) no no
Autocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes (recommended no (calibrants are not stored onboard)/yes (recommended no (calibrants are not stored onboard)/yes (recommended
avg. frequency: assay dependent) avg. frequency: 28 days) avg. frequency: 28 days)
Typical calibration frequency for ISE/therapeutic drugs/ 1 day/14 days/14–20 days/30 days/— —/—/—/—/28 days —/—/—/—/28 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown yes (90 sec. warm-up time)/yes no/no no/no
Onboard real-time QC/Onboard software capability to review QC yes/yes no/yes no/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management direct to drain direct to drain direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no
Lab can control analyzer from remote computer yes yes yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (instrument can order parts without operator intervention) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes no yes
Data-management capability/LIS or EHR systems interfaced onboard/Cerner, Antrim, CCA, Chemware, Dawning onboard/— onboard/Cerner, Antrim, CCA, Chemware, Dawning
Technologies, SCC, Dynamic Healthcare, Antek, more Technologies, SCC, Dynamic Healthcare, Antek, more
LIS interface provided/Bidirectional interface capability yes (included in instrument price)/yes (broadcast download yes (included in instrument price)/yes (broadcast download yes (included in instrument price)/yes (broadcast download
and host query) and host query) and host query)
Modem servicing provided/Service engineer on-site response time yes/within 24 hrs. yes/within 24 hrs. yes/within 24 hrs.
Mean time between failures 1.1 down service calls per year (displays error codes for — (displays error codes for troubleshooting) 3.1 down service calls per year (displays error codes for
troubleshooting) troubleshooting)
Average scheduled maintenance time by lab personnel daily: 6 min.; weekly: 10 min.; monthly: 45 min. weekly: < 15 min.; monthly: 7 min. daily: < 10 min.; weekly: 15 min. at 5,000 tests;
monthly: 35 min. at 10,000 tests
Maintenance records kept onboard for user/vendor yes/no yes (includes audit trail of who replaced parts)/no yes/no
Maintenance training demonstration module onboard yes yes yes
Training included with purchase/Avg. time for basic user training yes (2 training slots)/3 days (combination of vendor and customer yes (2 training slots)/3 days (at vendor site) yes (2 training slots)/3 days (at vendor site)
sites; includes vendor training and in-lab operator training)
Advanced operator training/Extra charge for follow-up yes (at vendor site)/yes no/yes yes (at vendor site)/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/— yes (1 year)/—
Distinguishing features (supplied by company) • standardization across the AU family of chemistry analyzers • ZeroDaily Maintenance eliminates daily maintenance; less • onboard aliquoting quickly frees samples for other analyses
• lower total cost of ownership due to fewer consumables than 15 minutes of cleaning per week • scalable results across all immunoassay systems
and concentrated reagents • PrecisionVision Technology uses multiple cameras with • liquid, ready-to-use reagents
• most common parts can be changed in three steps in less defined algorithms to detect processing errors in real time
Note: a dash in lieu of an answer means company than 60 seconds and without tools • SimpleSolve provides instrument-guided troubleshooting
did not answer question or question is not applicable 24/7 with step-by-step instructions

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
54 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 4 of 16 Binding Site, part of Thermo Fisher Scientific Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group
Haley Braffett [Link]@[Link] Maria Crisostomo maria_crisostomo@[Link] Maria Crisostomo maria_crisostomo@[Link]
forMID– and HIGH–VOLUME San Diego, CA Hercules, CA Hercules, CA
LABORATORIES 858-291-4556 [Link]/bindingsite 800-224-6723 [Link] 800-224-6723 [Link]
Name of instrument Optilite BioPlex 2200 System EVOLIS
Type of instrument chemistry immunoassay immunoassay
Operational type/Model type continuous random access/benchtop continuous random access/floor standing batch, random access/benchtop
List price/First year sold in U.S. $111,521/2015 —/2006 —/2001
Targeted hospital bed size/Targeted test volume > 100/daily: > 50; monthly: ~1,000; annual: ~12,000 —/daily: ~800 samples > 50/up to 360 samples per shift
Company manufactures instrument no (manufactured by Thermo Fisher) yes no (manufactured by Stratec)
Other models in this family of analyzers — — —
No. of units in clinical use in U.S./Outside U.S. (countries) 282/596 (Spain, Germany, France, UK, Italy, Denmark, more) —/— (Australia, Canada, China, Europe, Hong Kong, Israel, —
Japan, Korea, New Zealand, Russia, Saudi Arabia)
Dimensions (H × W × D)/Instrument footprint 24.4 × 37 × 27.6 in./7.09 sq. ft. 53 × 72 × 34 in./12.9 sq. ft. 37 × 44 × 30 in./10 sq. ft.
Weight empty/Weight fully loaded 242 lbs./~260 lbs. 1,032 lbs./— 209 lbs./—
No. of different measured assays onboard simultaneously 34 (34 can be run and calibrated at one time) 51 (51 can be run and calibrated at one time) 4–8 (4–8 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 10 — —
Test throughput per hour/Assay run time 108 (108 tests in throughput)/8–23 min. (avg. 13 min.) up to 2,200 (up to 22 tests in throughput)/avg. 45 min. —
(assay dependent)
Chemistry:
No. of direct ion-selective electrode channels — — —
Detection methods photometry — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — —
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample — — —
Immunoassay:
Fully automated microplate immunoassay system — no yes (96 wells per microplate)
Methodologies supported — multiplex flow (cytometric) enzyme immunoassay
Separation methodologies — magnetic particle coated microwell
Stat time until completion of a ß-hCG test — — —
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type 100/self-contained multiuse 100 (assay panel dependent), 200 (HIV, vitamin D, Lyme 192/self-contained multiuse
total), 150 (ToRC IgM)/self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use yes (8°–10°C below ambient)/yes yes (2°–8°C)/yes no/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/no
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/90 min. or 54 specimens or 180 tests yes/480 min. or 800 specimens or 9,600 tests yes/180 specimens or 4 tests
Design of sample-handling system rack rack —
Uses washable cuvettes/Uses disposable cuvettes no/yes (can store up to 360 cuvettes) no/— no/yes
Min.–max. sample volume that can be aspirated at one time 2–200 µL 3–150 µL 10–100 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 120 µL/assay dependent/150 µL 3 µL/350 µL (tube size dependent)/250 µL 10 µL/10 µL/100 µL
Dedicated pediatric sample cup yes (dead volume: 150 µL) no no
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (13 × 75 mm, 12 × 75 mm) yes/no yes/no
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes no
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, clots; icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not available hemolysis, icterus, lipemia, clots not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to
analysis)/— analysis)/<1 part per million analysis)/—
Automatic rerun capability yes no no
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes no no
low results
Analyzer requires dedicated water supply no (2 L/hr. consumption during operation) no (0.5 L/hr. consumption during operation) no (0.5 L/hr. consumption during operation)
Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes (recommended yes (calibrants are not stored onboard)/yes (recommended no (calibrants are not stored onboard)/yes (recommended
avg. frequency: per lab protocol and every new lot) avg. frequency: 30 days [assay dependent]) avg. frequency: each run)
Typical calibration frequency for ISE/therapeutic drugs/ — —/—/—/—/30 days (assay dependent) —/—/—/—/each run
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no yes/— no/no
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte no yes yes
Waste management automated collection onboard instrument manually by user or automated collection onboard manually by user or automated collection onboard
instrument or direct to drain instrument
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer no no no
Instrument can diagnose its own malfunctions no (operator intervention required to order parts) yes (operator intervention required to order parts) no (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring no yes no
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced onboard/Epic, Sunquest, Orchard, Cerner, SCC Soft Computer onboard/Antrim, CCA, Cerner, Sunquest, CGM Schuylab, Data onboard/—
Innovations, SCC Soft Computer, Meditech, Orchard, more
LIS interface provided/Bidirectional interface capability yes (additional cost)/yes (broadcast download and host query) no/yes (broadcast download and host query) no/yes (broadcast download)
Modem servicing provided/Service engineer on-site response time no/next business day yes/< 24 hrs. yes/24 hrs.
Mean time between failures 240 days (displays error codes for troubleshooting) — (displays error codes for troubleshooting) — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 10 min.; weekly: 15 min.; monthly: 30 min. daily: 5 min.; weekly: 30 min.; monthly: ~60 min. daily: 5 min.; monthly: < 60 min.
Maintenance records kept onboard for user/vendor some records (log)/no yes/yes (both include audit trail of who replaced parts) yes/yes (includes audit trail of who replaced parts)
Maintenance training demonstration module onboard no no no
Training included with purchase/Avg. time for basic user training yes (2 training slots)/2 days (primarily at customer site) yes (2 training slots)/5 days (at vendor site) yes (2 training slots)/5 days (at customer site)
Advanced operator training/Extra charge for follow-up yes (at customer site)/$2,500 no/yes no/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/$12,950 yes (1 year)/— yes (1 year)/—
Distinguishing features (supplied by company) • reduced carryover due to disposable cuvettes • full random-access automation with innovative multiplex • fully automated system that performs EIA assays with
• dilution cascade to final result chemistry; internal QC beads for monitoring test performance; positive sample identification
• intuitive software that includes three different antigen 51 assays: 26 autoimmune, 24 infectious disease, vitamin D • n etwork workstations for higher throughput
excess protection methods, optimized by assay • compatible track line connectivity option • s emi-open system with bidirectional LIS and
• CylancePROTECT Antivirus program provides digital comprehensive range of assays
protection against malware
Note: a dash in lieu of an answer means company
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 55

Part 5 of 16 Bio-Rad Laboratories Clinical Diagnostics Group Bio-Rad Laboratories Clinical Diagnostics Group bioMérieux
Maria Crisostomo maria_crisostomo@[Link] Maria Crisostomo maria_crisostomo@[Link] Kara Hardin [Link]@[Link]
forMID– and HIGH–VOLUME Hercules, CA Hercules, CA Salt Lake City, UT
LABORATORIES 800-224-6723 [Link] 800-224-6723 [Link] 800-682-2666 [Link]
Name of instrument PhD lx PR4100 Microplate Reader VIDAS 3
Type of instrument immunoassay immunoassay immunoassay
Operational type/Model type batch/benchtop batch/benchtop batch, random access, continuous random access/
benchtop
List price/First year sold in U.S. —/2012 —/2012 —/2015
Targeted hospital bed size/Targeted test volume —/daily: 50–200 samples — —

Company manufactures instrument yes yes yes

Other models in this family of analyzers — — VIDAS, MINI VIDAS
No. of units in clinical use in U.S./Outside U.S. (countries) — — > 500/—
Dimensions (H × W × D)/Instrument footprint 30 × 36 × 27 in./7 sq. ft. 5.3 × 13.7 × 7.4 in./— 24 × 29.5 × 25.5 in./5.2 sq. ft.
Weight empty/Weight fully loaded 112 lbs./— 5.7 lbs./— 154 lbs./—
No. of different measured assays onboard simultaneously — — 12 (several different lots of assays can be stored at one time)
No. of user-definable (open chemistry) channels — — —
Test throughput per hour/Assay run time — — up to 36/assay dependent

Chemistry:
No. of direct ion-selective electrode channels — — —
Detection methods — — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — —
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample — — —
Immunoassay:
Fully automated microplate immunoassay system yes (96 tests per unit containing up to 8 different assays; 96 no no
wells per microplate)
Methodologies supported fluorescence, enzyme immunoassay enzyme immunoassay enzyme-linked fluorescent assay (ELFA) technology
Separation methodologies none necessary none necessary —
Stat time until completion of a ß-hCG test — — 25 min. (measures intact molecule)
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type 192/open reagent system — 30–60 per kit/self-contained single use
Reagents refrigerated onboard/Reagents ready to use no/yes no/— no/yes
Reagent lot tracking/Reagent inventory yes/no no/no yes/—
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/no liquid chemistry (open reagent system)/— liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no — yes/yes
Walkaway capability/Walkaway duration yes/192 specimens or 8 EIA or 4 IFA assays no/— yes/27 specimens or 12 tests
Design of sample-handling system benchtop, reagent rack batch, benchtop rack
Uses washable cuvettes/Uses disposable cuvettes no/no no/no no/—
Min.–max. sample volume that can be aspirated at one time 1–100 µL — 100–300 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 1 µL/1 µL/150 μL — 100 µL/100 µL/125 µL for aliquot tubes
Dedicated pediatric sample cup no no yes
Primary tube sampling yes no yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (12–13 × 100 mm, 75 × 100 mm) no (microplate reader)/no (microplate reader) yes/—
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision no no —
Detects clots/liquid level/short sample no/yes/yes yes/yes/no yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots hemolysis, icterus, lipemia, clots not available hemolysis, icterus, lipemia, clots not available —
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to no/— yes (can be programmed to perform dilutions prior to
analysis)/— analysis)/no carryover
Automatic rerun capability no no no
Sample volume can be diluted to rerun out-of-linear-range high results yes no yes
Sample volume can be concentrated to rerun out-of-linear-range no no no
low results
Analyzer requires dedicated water supply no no no
Autocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes (recommended no (calibrants are not stored onboard)/no yes (calibrants are not stored onboard)/yes (recommended
avg. frequency: each run) avg. frequency: 14, 28, or 56 days)
Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/each run — —/—/—/—/every 14, 28, or 56 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no no/no yes (5 min. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC no/yes no/no yes/yes
Supports multiple QC lot numbers per analyte no no yes
Waste management manually by user or automated collection onboard instrument manually by user manually by user or automated collection onboard instrument
Sample barcode-reading capability/Autodiscrimination yes (Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer no no yes
Instrument can diagnose its own malfunctions no (operator intervention required to order parts) no (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring no no yes
UPS backup power supply yes no yes
Data-management capability/LIS or EHR systems interfaced onboard/— no/— onboard/Cerner, SCC Soft Computer, Meditech, Epic, more
LIS interface provided/Bidirectional interface capability no/yes (broadcast download and host query) no/no yes (additional cost)/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time no/24 hrs. no/— no/< 24 hrs.
Mean time between failures — (displays error codes for troubleshooting) — > 1 year (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: < 5 min.; < weekly: 15 min.; monthly: < 30 min. — weekly: 10–15 min.
Maintenance records kept onboard for user/vendor no/no no/no yes/no
Maintenance training demonstration module onboard no no no
Training included with purchase/Avg. time for basic user training yes (2 training slots)/2 days (at customer site) yes (2 training slots)/1 day (at customer site) yes/— (at customer site)
Advanced operator training/Extra charge for follow-up no/yes no/yes —
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes/— yes (1 year)/—
Distinguishing features (supplied by company) • open platform with assay programming wizard and • comprehensive data-analysis software for full traceability • specialty menu of critical care (acute kidney injury, sepsis,
capability to run IFA and EIA methods on a single • LIS connectivity thrombosis), infectious disease (MMRV, Lyme, C. difficile,
instrument • compact size–space saver H. pylori, toxoplasmosis, CMV), and hormone (hCG) assays
• accurate delivery of volumes as low as 1 μL • easy-to-use benchtop immunoassay system with ready-to-
• unique IFA hyperwash, resulting in lower background use assay format
fluorescence •m ean time between failure > 370 days

Note: a dash in lieu of an answer means company

did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
56 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 6 of 16 Diasorin Diatron Diazyme Laboratories

Technical Support [Link]@[Link] Frank Matuszak [Link]@[Link] Ericka Borges marketing@[Link]
forMID– and HIGH–VOLUME Stillwater, MN Medley, FL Poway, CA
LABORATORIES 800-328-1482 or 651-439-9710 [Link] 833-228-7931 [Link] 858-455-4768 [Link]
Name of instrument LIAISON XL Pictus 700 (P700) DZ-Lite 3000 Plus
Type of instrument immunoassay chemistry immunoassay
Operational type/Model type batch, random access, continuous random access, discrete/ batch, random access, continuous random access, batch, random access/floor standing
floor standing discrete/floor standing
List price/First year sold in U.S. —/2010 $60,190/2013 $60,000/2017
Targeted hospital bed size/Targeted test volume > 300/≥ 50,000 50–250/daily: 1,000–4,000; monthly: 30,000–120,000; —/daily: 1,000; monthly: 30,000; annual: 350,000
annual: 365,000–1,460,000
Company manufactures instrument no — no (manufactured by SNIBE Diagnostics)
Other models in this family of analyzers LIAISON XS Pictus 500 (P500) —
No. of units in clinical use in U.S./Outside U.S. (countries) > 800/> 6,500 < 100/> 750 (Europe, Latin America, Africa, Middle East, Asia) 55/1 (Philippines, Netherlands)
Dimensions (H × W × D)/Instrument footprint 59 × 59 × 36 in./14.6 sq. ft. 39.4 × 38.1 × 26.4 in./7.1 sq. ft. 59.8 in. × 56.7 in. × 30 ft./—(3.5 ft. recommended clearance)
Weight empty/Weight fully loaded —/661 lbs. 418 lbs./478 lbs. 502 lbs./—
No. of different measured assays onboard simultaneously 25 (25 can be run and calibrated at one time) 72 (up to 72 can be run and calibrated at one time) 25 (25 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 0 — 0
Test throughput per hour/Assay run time up to 171/16–65 min. (avg. 35 min.) 720/30–1,200 sec. (avg. 300 sec.) 180 (180 tests in throughput, assay dependent)/
15–45 min. (avg. 30 min.)
Chemistry:
No. of direct ion-selective electrode channels — 3 —
Detection methods — photometry, potentiometry —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — 2 min./60 specimens per hr. —
• Basic metabolic panel — 7.5 min./60 specimens per hr. —
• Complete metabolic panel — 9 min./50 specimens per hr. —
Typical time delay from ordering stat test until aspiration of sample — 24 sec. —
Immunoassay:
Fully automated microplate immunoassay system no — no
Methodologies supported chemiluminescence — chemiluminescence
Separation methodologies magnetic particle — magnetic particle
Stat time until completion of a ß-hCG test — — —
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type 50, 100, 200 (assay dependent)/self-contained multiuse 50–200 per set, 400–1,800 per pack/self-contained 100/self-contained multiuse
multiuse, open reagent system
Reagents refrigerated onboard/Reagents ready to use yes (12°C)/yes yes (8° ±2°C)/yes yes (10°)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/no liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/360 min. or 120 specimens or 1,000 tests yes/180 min. or 95 specimens or 1,800 tests yes/144 specimens or 1,500 tests
Design of sample-handling system rack rack rack
Uses washable cuvettes/Uses disposable cuvettes no/yes (can store up to 1,000 cuvettes) yes/yes (can store up to 160 cuvettes) no/yes (can store up to 700 cuvettes)
Min.–max. sample volume that can be aspirated at one time 50–1,000 µL 2–100 µL 5–300 µL
Min. reaction volume/Min. specimen volume/Min. dead volume —/5 µL/150 µL 180 µL/22 µL/100 µL 200 µL/120 µL/100 µL
Dedicated pediatric sample cup yes (dead volume: 50 µL) yes (dead volume: 20 µL) no
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes yes/no yes/no
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes no
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes —/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to
analysis)/— analysis)/30 parts per million analysis)/—
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results no yes yes
Sample volume can be concentrated to rerun out-of-linear-range no yes no
low results
Analyzer requires dedicated water supply no no (< 3 L/hr. consumption during operation) no
Autocalibration/Multipoint calibration supported yes (calibrants can be stored onboard)/yes (recommended yes (calibrants can be stored onboard)/yes (recommended no (calibrants can be stored onboard)/yes (recommended
avg. frequency: 4 weeks [assay dependent]) avg. frequency: 7 days) avg. frequency: 7 days)
Typical calibration frequency for ISE/therapeutic drugs/ — 8 hr./—/7 days/14 days/14 days —/—/—/—/7 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no no/no no/no
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management automated collection onboard instrument or direct to drain manually by user or direct to drain manually by user or direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, EAN
8/13, Code 93, UPCA/UPCE)/yes
Lab can control analyzer from remote computer no yes yes
Instrument can diagnose its own malfunctions no (operator intervention required to order parts) yes (operator intervention required to order parts) yes (instrument can order parts without operator intervention)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes yes no
Data-management capability/LIS or EHR systems interfaced onboard/Cerner, Epic, Sunquest, Vistar, SCC Soft Computer, onboard/AP Visions, Medicus, CGM Schuylab, Labtrack, CGM onboard/—
Orchard, Meditech, Comtron, ApolloLIMS, LabWare, more LabDaq, Medytox
LIS interface provided/Bidirectional interface capability no/yes (broadcast download and host query) yes (additional cost)/yes (broadcast download and host query) no/yes (host query)
Modem servicing provided/Service engineer on-site response time yes/24 hrs. no/48 hrs. no/24 hrs.
Mean time between failures — (displays error codes for troubleshooting) 1 year (displays error codes for troubleshooting) 1 year (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 10 min.; weekly: 20 min.; monthly: 30 min. daily: 30 min.; weekly: 1 hr.; monthly: 2 hr. daily: 20 min.; weekly: 20 min.; monthly: 90 min.
Maintenance records kept onboard for user/vendor yes/no no/no no/no
Maintenance training demonstration module onboard no no yes
Training included with purchase/Avg. time for basic user training yes (3 training slots)/— (at customer site) yes (2 training slots)/3 days (at customer site) yes (as many training slots as needed)/2 hours (at
customer site)
Advanced operator training/Extra charge for follow-up yes (at vendor site)/— yes (at customer or vendor site)/yes yes (at customer site)/no
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/$5,500 yes (1 year)/—
Distinguishing features (supplied by company) • secure traceability of all processes, status of reagents, and • uninterrupted workflow • unique menu
consumables • Windows-based, intuitive, user-friendly software • advanced chemiluminescent technology
• disposable pipette tips prevent sample carryover • high-quality components for long stability and result • for clinical and research applications
• no daily maintenance–instrument monitors maintenance reliability
needs
Note: a dash in lieu of an answer means company
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 57

Part 7 of 16 Dynex Technologies ELITechGroup EUROIMMUN Medizinische Labordiagnostika

Global Customer Service customerservice@[Link] Trish Worman [Link]@[Link] Product Management Auto. automation-pm@[Link]
forMID– and HIGH–VOLUME Chantilly, VA Logan, UT Luebeck, Germany
LABORATORIES 800-288-2354 [Link] 435-752-6011 [Link] +49 451 2032-0 [Link]
Name of instrument Agility Automated ELISA System Envoy 500/Envoy 500+ Chemistry Analyzer EUROLabWorkstation ELISA
Type of instrument immunoassay chemistry immunoassay
Operational type/Model type batch/benchtop batch, random access, continuous random access, discrete/ batch/benchtop
benchtop
List price/First year sold in U.S. —/2012 $85,000/2004 (Envoy 500), 2014 (Envoy 500+) —/2017
Targeted hospital bed size/Targeted test volume — —/daily: 20–80 patients; monthly: 4,200–17,000; annual: —/> 3,000
50,000–200,000
Company manufactures instrument yes no (also sold by McKesson, RedByrd, Henry Schein) yes (also sold by EUROIMMUN US)
Other models in this family of analyzers DSX — —
(No. of units in clinical use in U.S./Outside U.S. (countries) —/425 (worldwide) 250/— —
Dimensions (H × W × D)/Instrument footprint 49 × 50 × 36 in./12.5 sq. ft. 27 × 40 × 23 in./10 sq. ft. ~34 × 129 × 32 in./—
Weight empty/Weight fully loaded 469 lbs./— 209 lbs./219 lbs. ~760 lbs./~990 lbs.
No. of different measured assays onboard simultaneously up to 16 SmartKit reagent packs (up to 16 can be run and 40 (40 can be run and calibrated at one time) 180 (180 can be run and calibrated at one time)
calibrated at one time)
No. of user-definable (open chemistry) channels — (up to 16 can be active simultaneously) 500 (40 can be active simultaneously) —
Test throughput per hour/Assay run time assay dependent (up to 1,536 tests per run)/assay dependent 490/— > 200 (assay dependent)/—
Chemistry:
No. of direct ion-selective electrode channels — 4 —
Detection methods — photometry —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — 3 min., 45 sec./37 specimens per hr. —
• Basic metabolic panel — 10 min./588 specimens per hr. —
• Complete metabolic panel — 15 min./266 specimens per hr. —
Typical time delay from ordering stat test until aspiration of sample — < 1 min. —
Immunoassay:
Fully automated microplate immunoassay system yes (up to 12 tests per unit; 96 wells per microplate) — yes (180 tests per unit; 96 wells per microplate)
Methodologies supported enzyme immunoassay — enzyme immunoassay
Separation methodologies coated microwell — coated microwell
Stat time until completion of a ß-hCG test — — —
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type —/open system with self-contained multiuse SmartKit varies/open reagent system 96/open reagent system
Reagents refrigerated onboard/Reagents ready to use no (23° ±4°C)/yes yes (10°–15°C)/yes no/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/yes no/no no/no
Walkaway capability/Walkaway duration yes/up to 1,152 specimens or up to 1,152 tests yes/240 min. or 52 specimens or > 1,000 tests/assays yes/up to 480 min. or 800 specimens or 1,440 tests
Design of sample-handling system rack ring rack
Uses washable cuvettes/Uses disposable cuvettes no/no yes/no (can store up to 34 cuvettes) no/yes (can store up to 1,440 cuvettes)
Min.–max. sample volume that can be aspirated at one time 10–300 µL 1–100 µL 5–1,100 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 10 µL/—/— 300 µL/1 µL/100 µL 100 µL/5 µL/75 µL
Dedicated pediatric sample cup no no yes (dead volume: 75 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (17 × 100 mm) yes/yes yes/yes (10–16 × 100 mm)
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision no yes yes
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes no/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not available detection for clots
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to
analysis)/no carryover analysis)/— analysis)/1.3 parts per million
Automatic rerun capability no yes no
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range no no no
low results
Analyzer requires dedicated water supply no no (1 L/hr. consumption during operation) no
Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes (recommended no (calibrants are not stored onboard)/yes no/yes (recommended avg. frequency: each run)
avg. frequency: assay dependent)
Typical calibration frequency for ISE/therapeutic drugs/ —/assay dependent/assay dependent/—/assay dependent 4 hrs./—/—/7–31 days/— —/—/—/—/each run
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no yes (7 min. start-up time)/yes —
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes —
Waste management automated collection onboard instrument automated collection onboard instrument or direct to drain automated collection onboard instrument or direct to drain
Sample barcode-reading capability/Autodiscrimination yes (UPC, Codabar, Code 39, Code 128, Code 93)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/no yes (Interleaved 2 of 5, Codabar, Code 39, Code 128,
Data Matrix)/—
Lab can control analyzer from remote computer no no yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced onboard/Orchard, Cerner onboard/CGM LabDaq, CGM SchuyLab, McKesson Horizon onboard/—
Lab, Medicus Solutions, more
LIS interface provided/Bidirectional interface capability no/yes (host query) no/yes (host query) yes (additional cost)/yes (host query)
Modem servicing provided/Service engineer on-site response time no/24 hrs. no/24 business hrs. yes/—
Mean time between failures 200 days (displays error codes for troubleshooting) — (displays error codes for troubleshooting) — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 10 min.; weekly: 5 min. weekly: 15 min.; monthly: 15 min. —
Maintenance records kept onboard for user/vendor no/no yes/no yes/yes
Maintenance training demonstration module onboard no no yes
Training included with purchase/Avg. time for basic user training no/3 days (at customer site) yes (2 training slots)/3 days (at customer site) yes (1 training slot)/1 day (at customer site)
Advanced operator training/Extra charge for follow-up yes (at customer site)/yes yes (at customer site)/no yes (at customer or vendor site)/—
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/$8,995 (M–F, 8 am–7 pm) yes (1 year)/—
Distinguishing features (supplied by company) • increases productivity–full walkaway processing from • fast benchtop chemistry system • high-throughput system: more than 200 tests per hour for up to
beginning of testing with up to 16 SmartKit carriers stored • reusable glass cuvettes eliminate cost of disposable cuvettes 15 ELISA plates in one run
• practical automation–assesses testing requirements, • 4-parameter (Na+, K+, Cl-, CO2) dry electrodes reduce • flexible and fully code-tracked loading for patient samples,
develops efficient work list, continuous sample loading costs and maintenance time, increase reliability of results reagents, and labware without predefined positioning
• value–frees up labor time, allows for multitasking by • convenient and intuitive operation of hardware and software
Note: a dash in lieu of an answer means company eliminating most of ELISA labor with QC conformant tracking of actions and real walkaway time
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
58 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 8 of 16 EUROIMMUN Medizinische Labordiagnostika FUJIFILM Healthcare Americas Corp. Fujirebio US

Product Management Auto. automation-pm@[Link] Amador Alejo [Link]@[Link] Amanze Orusakwe [Link]@[Link]
forMID– and HIGH–VOLUME Luebeck, Germany Lexington, MA Malvern, PA
LABORATORIES +49 451 2032-0 [Link] 877-714-1924 [Link] 844-544-3787 [Link]
Name of instrument EUROLabWorkstation IFA µTASWako i30 LUMIPULSE G1200
Type of instrument immunoassay immunoassay immunoassay
Operational type/Model type batch/benchtop random access/benchtop continuous random access/floor standing
List price/First year sold in U.S. —/2019 —/2011 $118,000/2016
Targeted hospital bed size/Targeted test volume —/up to 3,000 — > 50/daily: 80; monthly: 16,000; annual: 200,000
Company manufactures instrument yes (also sold by EUROIMMUN US) no (manufactured by FUJIFILM Wako Pure Chemical Corp.) no (manufactured by Otsuka)
Other models in this family of analyzers — — —
No. of units in clinical use in U.S./Outside U.S. (countries) — 25/400 (Canada, Germany, Japan, China, South Korea, 18/> 1,000 (Japan, Germany, France, Italy, Belgium, more)
Vietnam, Thailand, Malaysia, Philippines)
Dimensions (H × W × D)/Instrument footprint ~34 × 115 × 32 in./— 21.5 × 20.5 × 23.4 in./3.34 sq. ft. 57.6 × 47.2 × 31.5 in./14.2 sq. ft.
Weight empty/Weight fully loaded ~760 lbs./~990 lbs. 157 lbs./— 727 lbs./794 lbs.
No. of different measured assays onboard simultaneously 75 (75 can be run and calibrated at one time) 6 (6 can be run and calibrated at one time) 36 (36 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels — 0 —
Test throughput per hour/Assay run time > 200 (assay dependent)/— 25/— 120 (120 tests in throughput)/avg. 25 min.
Chemistry:
No. of direct ion-selective electrode channels — — —
Detection methods — — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — —
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample — — —
Immunoassay:
Fully automated microplate immunoassay system no no no
Methodologies supported fluorescence fluorescence chemiluminescence
Separation methodologies BIOCHIPS on indirect immunofluorescence slides microcapillary gel electrophoresis magnetic particle
Stat time until completion of a ß-hCG test — — 30 min.
• Typical time delay from test order to aspiration of sample — — none
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type up to 1,200/self-contained multiuse 100/self-contained multiuse 42/self-contained single use
Reagents refrigerated onboard/Reagents ready to use no/yes yes (2°–10°C)/yes yes (2°–8°C)/no
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/no liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no —/yes
Walkaway capability/Walkaway duration yes/up to 360 min. or ~700 specimens or 750 tests yes/190 min. or 50 specimens or 80 tests yes/100 specimens
Design of sample-handling system rack rack rack
Uses washable cuvettes/Uses disposable cuvettes no/no no/no no/no
Min.–max. sample volume that can be aspirated at one time 5–1,100 µL 3 µL minimum 10–140 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 100 µL/5 µL/75 µL —/75 µL/72 µL 150 µL/110 µL/100 µL
Dedicated pediatric sample cup yes (dead volume: 75 µL) no no
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (10–16 × 100 mm) yes/yes yes/yes
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes no
Detects clots/liquid level/short sample no/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots hemolysis, icterus, lipemia, clots not available detection for clots; hemolysis, icterus, lipemia not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to no/0.1 parts per million yes (can be programmed to perform dilutions prior to
analysis)/1.3 parts per million analysis)/1 part per million
Automatic rerun capability no yes no
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range no no no
low results
Analyzer requires dedicated water supply no no no (2.1 L/hr. consumption during operation)
Autocalibration/Multipoint calibration supported no/— yes (calibrants are not stored onboard)/— no (calibrants are not stored onboard)/yes (recommended
avg. frequency: 30 days)
Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/assay dependent — —/—/—/—/30 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown — no/no yes (5 min. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes no/yes yes/yes
Supports multiple QC lot numbers per analyte — yes yes
Waste management automated collection onboard instrument or direct to drain automated collection onboard instrument manually by user or direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, ITF, yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, Standard
Data Matrix)/— EAN/JAN-13, EAN/JAN-18, STF(5BER), EAN-128)/yes 2 of 5)/no
Lab can control analyzer from remote computer yes no no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) no (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes no no
UPS backup power supply yes no yes
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/— onboard/SCC Soft Computer, more
LIS interface provided/Bidirectional interface capability yes (additional cost)/yes (host query) no/yes (host query) yes (included in instrument price)/yes (broadcast download
and host query)
Modem servicing provided/Service engineer on-site response time yes/— no/based on contract no/24 hrs.
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 400 days (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel — daily: 0; weekly: 0; monthly: 15 min. daily: 15 min.; weekly: 30 min.; monthly: 45 min.
Maintenance records kept onboard for user/vendor yes/yes no/— no/no
Maintenance training demonstration module onboard yes no yes (2 training slots per module)
Training included with purchase/Avg. time for basic user training yes (1 training slot)/1 day (at customer site) yes/~2 days (at customer site) yes/6 hrs. (at customer site)
Advanced operator training/Extra charge for follow-up yes (at customer or vendor site)/— — yes (at customer site)/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/— yes (1 year)/$14,375
Distinguishing features (supplied by company) • high-throughput system: more than 200 tests per hour for • microfluidics technology; small footprint–tabletop; liver • unitized immunoreaction cartridge eliminates open bottle
up to 750 reaction fields in one run cancer risk markers stability concerns and waste due to dead volume
• flexible and fully code-tracked loading for patient samples, • small sample volume • 30-min. time to result for all assays
reagents, and labware without predefined positioning • fast turnaround time • uninterrupted productivity–replenishes samples, reagents,
• fully automated IIFT processing from primary sample to and consumables on the fly
cover-slipped slide with real walkaway time

Note: a dash in lieu of an answer means company

did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 59

Part 9 of 16 Gold Standard Diagnostics Gold Standard Diagnostics HORIBA Medical

Christina Brusca [Link]@[Link] Christina Brusca [Link]@[Link] Susan Behnke [Link]@[Link]
forMID– and HIGH–VOLUME Davis, CA Davis, CA Irvine, CA
LABORATORIES 530-759-8000 [Link] 530-759-8000 [Link] 888-903-5001 [Link]/us/en/medical/
Name of instrument AIX1000 Agglutination Instrument ThunderBolt Yumizen C1200
Type of instrument immunoassay immunoassay chemistry
Operational type/Model type batch/benchtop batch/benchtop continuous random access/floor standing
List price/First year sold in U.S. —/2016 —/2011 $179,800/2020
Targeted hospital bed size/Targeted test volume — — < 300/daily: 9,520; monthly: 17,000; annual: 2 million
Company manufactures instrument yes (also sold by Cardinal Health, Thermo Fisher Scientific, yes (also sold by distribution partners) yes (manufactured by HORIBA ABX SAS; also sold by
VWR) distribution partners)
Other models in this family of analyzers — Bolt Yumizen C1200 AL
No. of units in clinical use in U.S./Outside U.S. (countries) — —/— (Australia, Austria, Belgium, Bolivia, Brazil, Canada, —
Chile, Colombia, Czech Republic, England, Finland, more)
Dimensions (H × W × D)/Instrument footprint 17.7 × 25.3 × 22.5 in./4.1 sq. ft. 17.7 × 25.2 × 22.5 in./6.5 sq. ft. 44 × 48 × 33.5 in./—
Weight empty/Weight fully loaded 62 lbs./~110 lbs. 62 lbs./110 lbs. 992 lbs./—
No. of different measured assays onboard simultaneously 2 (2 can be run and calibrated at one time) up to 24 (with limitations) 45 (45 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels — — 100 (100 can be active simultaneously)
Test throughput per hour/Assay run time 128 (128 tests in throughput)/75 min. dependent on assay incubation times (192 tests in 1,200 (45 plus 3 ISE tests in throughput)/3–15 min.
throughput)/20 min.–4 hr. (avg. 2 hr.)
Chemistry:
No. of direct ion-selective electrode channels — — 3
Detection methods — — photometry, potentiometry, enzyme immunoassay,
immunoturbidimetry
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — 2.4 min./200 specimens per hr.
• Basic metabolic panel — — 12 min./60 specimens per hr.
• Complete metabolic panel — — 12 min./58 specimens per hr.
Typical time delay from ordering stat test until aspiration of sample — — 81 sec.
Immunoassay:
Fully automated microplate immunoassay system no yes (192 tests per unit; 96 wells per microplate) —
Methodologies supported agglutination chemiluminescence, enzyme immunoassay —
Separation methodologies none necessary coated microwell —
Stat time until completion of a ß-hCG test — — —
• Typical time delay from test order to aspiration of sample — — —
Stat time until completion of a cTn test — — —
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type 480/self-contained multiuse 96/open reagent system 500–2,200/self-contained multiuse, open reagent system
Reagents refrigerated onboard/Reagents ready to use no/— no (room temperature–40°C)/variable; reagent specific yes (2°–8°C)/variable; reagent specific
Reagent lot tracking/Reagent inventory no/no yes/no yes/yes
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/no liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/yes no/no
Walkaway capability/Walkaway duration yes/20–90 min. yes/dependent on reagent yes/dependent on reagent
Design of sample-handling system universal slide-in racks slide-in racks 84 sample continuous loading ring, optional autoloading rack
Uses washable cuvettes/Uses disposable cuvettes no/no no/no yes/no (can store up to 231 cuvettes)
Min.–max. sample volume that can be aspirated at one time 1–150 µL 1–300 µL 1–25 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 105 µL/300 µL/150 µL 25 µL/151 µL/150 µL 80 µL/—/200 µL for primary tube sampling
Dedicated pediatric sample cup no no yes (dead volume: 50 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (12–16 × up to 100 mm) yes/yes yes/yes
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes yes
Detects clots/liquid level/short sample no/yes/yes no/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots not available hemolysis, icterus, lipemia, clots not available detection for hemolysis, icterus, lipemia, clots
Dilutes patient samples onboard/Susceptibility to carryover yes/— yes (can be programmed to perform dilutions prior to yes/—
analysis)/assay specific
Automatic rerun capability no no yes
Sample volume can be diluted to rerun out-of-linear-range high results no yes yes
Sample volume can be concentrated to rerun out-of-linear-range no yes —
low results
Analyzer requires dedicated water supply no (0.045 L/hr. consumption during operation) no yes (average of 20 L/hr. consumption during operation)
Autocalibration/Multipoint calibration supported — no (calibrants are not stored onboard)/yes (recommended yes (calibrants can be stored onboard [ISE])/yes
avg. frequency: per batch) (recommended avg. frequency: with each test kit)
Typical calibration frequency for ISE/therapeutic drugs/ — —/—/—/—/per batch daily/for QC failure/for QC failure/per test kit/—
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no (< 5 min. start-up time)/no no (5 min. start-up time)/no yes (40 min. start-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte no yes no
Waste management manually by user manually by user direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, EAN)/—
1D, 2D)/yes Code 93, more)/yes
Lab can control analyzer from remote computer yes no no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply no no no
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/— onboard/CGM Labdaq
LIS interface provided/Bidirectional interface capability yes/yes no/yes (host query) no/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time — no/48 hrs. no/< 24 hrs.
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 122 days (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: < 5 min.; weekly: < 20 min.; monthly: < 5 min. daily: 5 min.; weekly: 15 min.; monthly: 20 min. daily: 10–15 min. (walkaway); weekly: 20–30 min.;
monthly: < 60 min.
Maintenance records kept onboard for user/vendor yes/yes yes/some records (dye tests and calibrations) no/no
Maintenance training demonstration module onboard no no no
Training included with purchase/Avg. time for basic user training yes (minimum 1 training slot)/2 days (at customer site or online) yes/4 hrs. (at customer or vendor site) yes (1 training slot)/3 days (at vendor or customer site)
Advanced operator training/Extra charge for follow-up yes/— yes (at customer or vendor site)/yes (contract dependent) yes (at vendor site)/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year from shipment date)/— yes (contract dependent)/—
Distinguishing features (supplied by company) • universal slide-in racks accommodate a variety of tube • open architecture: program any EIA or CLIA protocol; fully •m  icrovolume technology for improved cost efficiency
sizes for easier and faster sample loading customizable with flexible and intuitive software • b ig lab automation in a small footprint; processes 1,200
• ability to add SMS and email alerts for notification of errors • space saving: high capacity (192 samples) in a 2 × 2 ft. footprint tests per hour with ion-selective electrodes
or test completion • cost saving: low instrument price point with no routine • 1 00 programmable applications; optional autoloader
• automated processing, analysis, interpretation, and result consumables required
and image archiving; 90 min. walkaway time for 192
Note: a dash in lieu of an answer means company specimens
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
60 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 10 of 16 HORIBA Medical Mindray North America QuidelOrtho

Brooke Bradley [Link]@[Link] Anna Chen [Link]@[Link] Laura Osborne [Link]@[Link]
forMID– and HIGH–VOLUME Canton, MI Redmond, WA Raritan, NJ
LABORATORIES 734-487-8300 [Link] 416-826-1883 [Link] 800-828-6316 [Link]
Name of instrument Yumizen C560 BS480 Vitros 3600 Immunodiagnostic System
Type of instrument chemistry chemistry immunoassay
Operational type/Model type random access, discrete/floor standing batch, random access, continuous random access, batch, random access, continuous random access,
discrete/floor standing discrete/floor standing
List price/First year sold in U.S. $110,000/2023 $80,000/2014 —/2008
Targeted hospital bed size/Targeted test volume < 275/daily: 3,000; monthly: 60,000; annual: 720,000 <280/daily: 3,000; monthly: 60,000; annual: 720,000 150–4,500/daily: > 200; monthly: > 5,000; annual: > 60,000
Company manufactures instrument yes (also sold by distribution partners) yes (also sold by Thermo Fisher, HORIBA) no (manufactured by Nypro Engineering and Technology
group service; also sold by Cardinal, McKesson, more)
Other models in this family of analyzers Yumizen C230, Yumizen C240 BA800 Vitros ECi/ECiQ Immunodiagnostic System
No. of units in clinical use in U.S./Outside U.S. (countries) — —/— (worldwide) > 150/> 690 (North, Central, and South Americas, more)
Dimensions (H × W × D)/Instrument footprint 45 × 46 × 28 in./35 sq. ft. 46 × 28 × 45 in./35 sq. ft. 65 × 84 × 35 in./19.4 sq. ft.
Weight empty/Weight fully loaded 661 lbs./— 661 lbs./— 1,740 lbs./—
No. of different measured assays onboard simultaneously 81 (up to 81 can be run and calibrated at one time) 81 (50 can be run and calibrated at one time) 31 (31 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels up to 50 (50 can be active simultaneously) 200 0
Test throughput per hour/Assay run time 560/1–10 min. (avg. 8 min.) 400 photometric, up to 240 ISE/1–10 min. (avg. 8 min.) 189/16–73 min. (avg. 30 min.)
Chemistry:
No. of direct ion-selective electrode channels 3 3 —
Detection methods photometry, potentiometry photometry, potentiometry, kinetic, end point, fixed time —
Stat time until completion/specimen throughput for:
• Ion-selective electrode ~4.2 min./~56 specimens per hr. 1 min./60 specimens per hr. —
• Basic metabolic panel ~7.7 min./~53 specimens per hr. 8 min./52 specimens per hr. —
• Complete metabolic panel ~10.5 min./~50 specimens per hr. 11 min./50 specimens per hr. —
Typical time delay from ordering stat test until aspiration of sample ~135 sec. ~2 min. —
Immunoassay:
Fully automated microplate immunoassay system — — no
Methodologies supported — — chemiluminescence, enzyme immunoassay, direct
enhanced chemiluminescence
Separation methodologies — — coated microwell
Stat time until completion of a ß-hCG test — — 24 min.
• Typical time delay from test order to aspiration of sample — — 1 min.
Stat time until completion of a cTn test — — 18 min.
• Typical time delay from test order to aspiration of sample — — 1 min.
Approximate No. of tests per reagent set/Reagent type 160–500 (reagent dependent)/open reagent system 160–500/open reagent system 50–100/self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use yes (2°–10°C)/variable; reagent specific yes (2°–10°C)/yes yes (10°C)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes — (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/143 min. or 87 specimens or 14 test panels yes/dependent on reagent yes/120 min. or 90 specimens or 3,100 tests
Design of sample-handling system ring ring, carousel circular routine sampling center
Uses washable cuvettes/Uses disposable cuvettes yes/no (can store up to 90 cuvettes) yes (can store up to 90 cuvettes)/no no/no
Min.–max. sample volume that can be aspirated at one time 1.5–45 µL 1.5–45 µL 2–200 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 120 µL/75 µL (test dependent)/70 µL 120 µL/75 µL/70 µL or 8 mm above gel barrier —/10 µL/35 µL
Dedicated pediatric sample cup yes (dead volume: 70 µL) yes (dead volume: 70 µL) yes (dead volume: 35 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/— yes/no yes/yes (micro sample cups, 10.25 × 45 mm, 12 × 75 mm, 12 ×
tube sizes 100 mm, 13 × 75 mm, 13 × 100 mm, 16 × 75 mm, 16 × 100 mm)
Pierces caps on primary tubes no no no
Protects against probe collision yes yes yes
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection and quantitation for hemolysis, icterus, lipemia; detection for hemolysis, icterus, lipemia detection and quantitation for hemolysis, icterus, lipemia;
detection for clots detection for clots
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to analysis)/0
analysis)/500 parts per million analysis)/< 500 parts per million
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes yes no
low results
Analyzer requires dedicated water supply yes (average of 20 L/hr. consumption during operation) yes (20 L/hr. consumption during operation) no (no water consumption during operation)
Autocalibration/Multipoint calibration supported yes (calibrants can be stored onboard)/yes (assay dependent) yes (calibrants can be stored onboard)/yes (recommended no (calibrants are not stored onboard)/yes (recommended avg.
avg. frequency: assay dependent) frequency: 28 days)
Typical calibration frequency for ISE/therapeutic drugs/ 8 hrs./as needed/as needed/14 days/— 8 hrs./—/—/—/— —/—/—/—/28 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown yes/yes yes (10 min. warm-up time)/yes no/no
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management automated collection onboard instrument or direct to drain automated collection onboard instrument or direct to drain manually by user
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/— yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/— yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128,
ISBT 128)/yes
Lab can control analyzer from remote computer no no no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes (optional) no yes
Data-management capability/LIS or EHR systems interfaced onboard/CGM Labdaq, Orchard, Sunquest, Apollo, Paracelsus onboard/yes (Paracelsus, Sunquest, Orchard, more) onboard/—
LIS interface provided/Bidirectional interface capability no/yes (host query) no/yes (broadcast download and host query) yes (additional cost)/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time no/1 business day no/contract dependent yes/4 hrs.
Mean time between failures — (displays error codes for troubleshooting) 2,500 hrs. (displays error codes for troubleshooting) — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: < 5 min.; weekly: 1 hr.; monthly: 25 min. daily: < 5 min.; weekly: ~ 1 hr.; monthly: 25 min. daily: < 10 min.; weekly: 30 min.; monthly: 20 min.
Maintenance records kept onboard for user/vendor yes (includes audit trail of who replaced parts)/some records yes (includes audit trail of who replaced parts)/no yes (includes audit trail of who replaced parts)/no
(log)
Maintenance training demonstration module onboard yes yes yes
Training included with purchase/Avg. time for basic user training yes/3 days (online and at customer site) yes (at least 1 training slot)/1 day (combination of vendor yes (2 training slots)/5 days (at customer site)
and customer sites; geography dependent)
Advanced operator training/Extra charge for follow-up no/— yes (combination of vendor and customer sites; geography yes (at customer site)/yes
or advanced training dependent)/yes (for service training)
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (2 years)/contract dependent yes (1 year)/depends on plan selected
Distinguishing features (supplied by company) • reagents: high-quality POINTE reagents, multiple lots • reliable, dependable, excellent support • Intellicheck technology reports on diagnostic checks
calibrated/QC at once, reagents can be loaded while running • easy operation, software intuitive, auto start-up, auto throughout the testing process to minimize errors for
• automated functions: startup, shutdown, calibration rerun, LIH, shutdown, autocalibration, auto reflex, and auto HIL consistent performance
reflex, probe (liquid level, collision, clot, bubble, more) • designed to use single-patient consumables without the
• resource efficiency: low reagent and sample use need for water, eliminating risk of carryover
Note: a dash in lieu of an answer means company • MicroSensor technology automates detection of HIL
did not answer question or question is not applicable interferences

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 61

Part 11 of 16 QuidelOrtho QuidelOrtho Randox Laboratories

Laura Osborne [Link]@[Link] Laura Osborne [Link]@[Link] Graeme McNeill [Link]@[Link]
forMID– and HIGH–VOLUME Raritan, NJ Raritan, NJ Kearneysville, WV
LABORATORIES 800-828-6316 [Link] 800-828-6316 [Link] 304-728-2890 [Link]
Name of instrument Vitros 4600 Chemistry System Vitros XT 7600 Integrated System RX imola
Type of instrument chemistry combination chemistry/immunoassay chemistry
Operational type/Model type batch, random access, continuous random access, batch, random access, continuous random access, discrete/benchtop
discrete/floor standing discrete/floor standing
List price/First year sold in U.S. —/2011 —/2018 —/2006
Targeted hospital bed size/Targeted test volume 150–4,500/daily: 600–3,000; monthly: 17,000–85,000; 150–4,500/daily: 600–3,000; monthly: 17,000–85,000; 75/daily: > 750; monthly: > 22,500; annual: > 270,000
annual: 200,000–1.5 million annual: 200,000–4 million
Company manufactures instrument no (manufactured by Nypro Engineering and Technology no (manufactured by Nypro Engineering and Technology yes
group service; also sold by Cardinal, McKesson, more) group service; also sold by Cardinal, McKesson, more)
Other models in this family of analyzers Vitros 350 Chemistry System, Vitros XT 3400 Chemistry System Vitros 5600 Integrated System RX misano, RX monaco, RX daytona +, RX modena
No. of units in clinical use in U.S./Outside U.S. (countries) > 160/> 980 (North, Central, and South Americas, more) > 460/> 400 (North, Central, and South Americas, more) 34/> 1,000 (> 120 countries)
Dimensions (H × W × D)/Instrument footprint 53 × 92 × 33 in./21.4 sq. ft. 68 × 110 × 34.9 in./26.7 sq. ft. 27 × 38 × 23 in./44.28 sq. ft.
Weight empty/Weight fully loaded 1,400 lbs./— 2,360 lbs./— 331 lbs./340 lbs.
No. of different measured assays onboard simultaneously 82 (82 can be run and calibrated at one time) 150 (150 can be run and calibrated at one time) 60 (60 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 20 (20 can be active simultaneously) 20 (20 can be active simultaneously) 15 (0 can be active simultaneously)
Test throughput per hour/Assay run time 845/2.5–20 min. (avg. 5 min.) 1,320/2.5–73 min. (avg. 7 min.) 560, including ISE (50 tests in throughput)/5–10 min. (avg. 6 min.)
Chemistry:
No. of direct ion-selective electrode channels 3 3 3
Detection methods photometry, potentiometry, colorimetric, turbidimetric photometry, potentiometry, turbidimetric, direct enhanced potentiometry
chemiluminescence
Stat time until completion/specimen throughput for:
• Ion-selective electrode 5 min./126 tests per hr. 5 min./126 tests per hr. 13 min. 15 sec./80 specimens per hr.
• Basic metabolic panel 6 min./84 tests per hr. 6 min./95 tests per hr. 13 min. 43 sec./80 specimens per hr.
• Complete metabolic panel 7.5 min./50 tests per hr. 7.5 min./74 tests per hr. 13 min. 15 sec./67 specimens per hr.
Typical time delay from ordering stat test until aspiration of sample 1 min. 1 min. 30 sec.
Immunoassay:
Fully automated microplate immunoassay system — no —
Methodologies supported — chemiluminescence, enzyme immunoassay, direct —
enhanced chemiluminescence
Separation methodologies — coated microwell —
Stat time until completion of a ß-hCG test — 24 min. —
• Typical time delay from test order to aspiration of sample — 1 min. —
Stat time until completion of a cTn test — 18 min. —
• Typical time delay from test order to aspiration of sample — 1 min. —
Approximate No. of tests per reagent set/Reagent type 60/self-contained single use, open reagent system 50–100/varies for chemistry and immunoassay 200/self-contained single use
Reagents refrigerated onboard/Reagents ready to use yes (10°C)/yes yes (10°C)/yes yes (8°–15°C)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded dry chemistry, liquid chemistry (open reagent system)/yes dry chemistry, liquid chemistry (open reagent system)/yes liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/120 min. or 160 specimens or 8,940 tests yes/— yes/70 min. or 40 specimens or 10 tests
Design of sample-handling system continuous load and unload, circular routine sample center continuous load and unload, circular routine sample center ring
Uses washable cuvettes/Uses disposable cuvettes no/yes (can store up to 348 cuvettes) no/yes (can store up to 348 cuvettess) yes (can store up to 90 cuvettes)/no
Min.–max. sample volume that can be aspirated at one time 2–200 µL 2–200 µL 1.5–35 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 0 µL/2 µL/35 µL 0 µL/2 µL/35 µL 150 µL/1.5–35 µL/150 µL
Dedicated pediatric sample cup yes (dead volume: 35 µL) yes (dead volume: 35 µL) yes (dead volume: 100 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (micro sample cups, 10.25 × 45 mm, 12 × 75 mm, 12 × yes/yes (micro sample cups, 10.25 × 45 mm, 12 × 75 mm, 12 × —
tube sizes 100 mm, 13 × 75 mm, 13 × 100 mm, 16 × 75 mm, 16 × 100 mm) 100 mm, 13 × 75 mm, 13 × 100 mm, 16 × 75 mm, 16 × 100 mm)
Pierces caps on primary tubes no no no
Protects against probe collision yes yes yes
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/no
Detection or quantitation for hemolysis, icterus, lipemia, clots detection and quantitation for hemolysis, icterus, lipemia; detection and quantitation for hemolysis, icterus, lipemia; detection and quantitation for hemolysis, icterus, lipemia;
detection for clots detection for clots clots not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to analysis)/0 yes (can be programmed to perform dilutions prior to analysis)/0 yes (can be programmed to perform dilutions prior to analysis)/
no carryover
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes yes yes
low results
Analyzer requires dedicated water supply no (no water consumption during operation) no (no water consumption during operation) yes (18 L/hr. consumption during operation)
Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes (recommended avg. no (calibrants are not stored onboard)/yes (recommended avg. no (calibrants can be stored onboard)/yes (recommended
frequency: 6 mos. or lot change for most chemistry assays) frequency: 6 mos. or lot change for most chemistry assays) avg. frequency: 14 days)
Typical calibration frequency for ISE/therapeutic drugs/ 6 mos./6 mos./6 mos./6 mos./— 6 mos./6 mos./6 mos./6 mos./28 days 1 day/7 days/7 days/14 days/28 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no no/no yes (9 min. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes —/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management manually by user manually by user direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes
ISBT 128)/— ISBT 128)/yes
Lab can control analyzer from remote computer no no yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes yes no
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/— onboard/—
LIS interface provided/Bidirectional interface capability yes (additional cost)/yes (broadcast download and host query) yes (additional cost)/yes (broadcast download and host query) yes (included in instrument price)/yes (host query)
Modem servicing provided/Service engineer on-site response time yes/4 hrs. yes/4 hrs. no/within 24 hrs.
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 2 per 3 years (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 5 min.; weekly: 30 min.; monthly: 20 min. daily: < 10 min.; weekly: 30 min.; monthly: 20 min. daily: 5 min.; weekly: 15 min.; monthly: 1 hr.
Maintenance records kept onboard for user/vendor yes (includes audit trail of who replaced parts)/no yes (includes audit trail of who replaced parts)/no no/no
Maintenance training demonstration module onboard yes yes no
Training included with purchase/Avg. time for basic user training yes (2 training slots)/5 days (at customer site) yes (2 training slots)/5 days (at customer site) yes (1 training slot)/3 days (at customer site)
Advanced operator training/Extra charge for follow-up yes (at customer site)/yes yes (at customer site)/yes yes (at customer site)/yes
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/depends on plan selected yes/depends on plan selected yes (1 year)/—
Distinguishing features (supplied by company) • Intellicheck technology reports on diagnostic checks • XT MicroSlide performs two tests on one slide, which • large and extensively dedicated test menu
throughout the testing process to minimize errors for doubles testing output, increases productivity, and fulfills • stat sample capabilities
consistent performance more requests from difficult draws • benchtop analyzer
• designed to use single-patient consumables without the • designed to use single-patient consumables without the
need for water, eliminating risk of carryover need for water, eliminating risk of carryover
Note: a dash in lieu of an answer means company • MicroSensor technology automates detection of HIL • MicroSensor technology automates detection of HIL
did not answer question or question is not applicable interferences interferences

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
62 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 12 of 16 Roche Diagnostics Roche Diagnostics Roche Diagnostics

John Kleinschmidt [Link]@[Link] John Kleinschmidt [Link]@[Link] John Kleinschmidt [Link]@[Link]
forMID– and HIGH–VOLUME Indianapolis, IN Indianapolis, IN Indianapolis, IN
LABORATORIES 800-428-5074 [Link]/us/en/[Link] 800-428-5074 [Link]/us/en/[Link] 800-428-5074 [Link]/cobasproUS
Name of instrument cobas 6000 analyzer series cobas 8000 modular analyzer series cobas pro integrated solutions
Type of instrument combination chemistry/immunoassay combination chemistry/immunoassay combination chemistry/immunoassay
Operational type/Model type random access, continuous random access/floor standing random access, continuous random access/floor standing random access, continuous random access/floor standing
List price/First year sold in U.S. —/2006 —/2010 —/2019
Targeted hospital bed size/Targeted test volume > 100/daily: 1,000–4,000; annual: 500,000–2,500,000 > 250/daily: > 4,000; annual: ≥ 2,500,000 > 200/daily: 2,000–4,000; annual: 750,000–4.5 million
Company manufactures instrument no (manufactured by Hitachi High-Technologies) no (manufactured by Hitachi High-Technologies) no (manufactured by Hitachi High-Technologies)
Other models in this family of analyzers chemistry: cobas c 501; immunoassay: cobas e 601 chem.: cobas c 701, c 702, c 502; immuno.: cobas e 801, e 602 cobas pure integrated solutions
No. of units in clinical use in U.S./Outside U.S. (countries) > 1,600/> 14,000 (56 countries) > 400/> 5,000 (49 countries) > 650/> 3,000 (> 40 countries)
Dimensions (H × W × D)/Instrument footprint 51 × 74–196 × 41 in./34.62 sq. ft. for 2-module configuration 40–53 × 99–294 × 45 in./66.35 sq. ft. for 3-module config. 56 × 172.2 × 47 in. for integrated 2-module system/54 sq. ft.
Weight empty/Weight fully loaded 830–1,990 lbs./830–1,990 lbs. 1,150–5,485 lbs./1,150–5,485 lbs. for integrated 2-module system: 4,388 lbs./4,388 lbs.
No. of different measured assays onboard simultaneously up to 151 (up to 148 can be run and calibrated at one time) up to 283 (> 300 can be run and calibrated at one time) chem: 63 (63 can be run and calibrated at one time);
immuno: 48 (48 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 20 (all can be active simultaneously) 10 for c 70x, c 502 (all can be active simultaneously) 10 (10 can be active simultaneously)
Test throughput per hour/Assay run time up to 2,170 (2,170 tests in throughput)/ISE: 12 sec.; chemistry: up to 9,800 (varies by module)/ISE: 12 sec.; chemistry: 3–10 min. up to 4,400 (varies by module)/chem: 4.5–10 min. (avg. 10
3–10 min. in 1-min. steps; immunoassay: 9–27 min. (avg. 18 min.) in 1-min. steps; immunoassay: 9–27 min. (avg. 18 min.) min.); immuno: 9–27 min. (avg. 18 min.)
Chemistry:
No. of direct ion-selective electrode channels 3 indirect 3 indirect 3 indirect
Detection methods photometry, potentiometry photometry, potentiometry photometry, potentiometry
Stat time until completion/specimen throughput for:
• Ion-selective electrode 4.5 min./133 specimens per hr. 4.5 min./600 specimens per hr. 4.5 min. for ISE, 10 min. with CO2/300 specimens per hr.
• Basic metabolic panel 7 min./up to 240 specimens per hr. 7 min./up to 400 specimens per hr. 10 min./200 specimens per hr.
• Complete metabolic panel 10 min./up to 110 specimens per hr. 10 min./up to 181 specimens per hr. 10 min./100 specimens per hr.
Typical time delay from ordering stat test until aspiration of sample < 1 min. < 1 min. < 1 min.
Immunoassay:
Fully automated microplate immunoassay system no no no
Methodologies supported electrochemiluminescence electrochemiluminescence electrochemiluminescence
Separation methodologies magnetic particle magnetic particle magnetic particle
Stat time until completion of a ß-hCG test 9 min. ~10 min. ~10 min.
• Typical time delay from test order to aspiration of sample 42 sec. < 1 min. < 1 min.
Stat time until completion of a cTn test 9 min. 9 min. ~10 min.
• Typical time delay from test order to aspiration of sample 42 sec. 24 sec. < 1 min.
Approximate No. of tests per reagent set/Reagent type up to 800 per pack (chemistry), up to 200 per pack up to 3,000 per pack (chemistry), up to 300 per pack up to 3,300 (chemistry), up to 300 (immunoassay)/
(immunoassay)/self-contained multiuse (immunoassay)/self-contained multiuse self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use yes (5°–12°C [chemistry], 20°±3°C [immunoassay])/yes yes (5°–15°C [chem], 6°–10°C [immuno])/reagent specific yes (5°–15°C [chemistry], 6°–10°C [immunoassay])/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/yes
Walkaway capability/Walkaway duration yes/75 min. or 150 samples or 1,500 tests yes/45 min. or 300 samples or 3,000 tests yes/30–45 min. or 300 samples or ~3,000 tests
Design of sample-handling system 5-position rack 5-position rack 5-position rack
Uses washable cuvettes/Uses disposable cuvettes immuno: yes (can store up to 1,008 cuvettes)/no yes (No. of cuvettes stored varies by module)/no yes (can store up to 221 cuvettes for chem, 1,575 for immuno)/yes
Min.–max. sample volume that can be aspirated at one time 1–35 µL 1–35 μL (chemistry), 1–60 μL (immunoassay) 1–60 μL
Min. reaction volume/Min. specimen volume/Min. dead volume 100–250 μL (chem), 120–200 μL (immuno)/1.5 μL (chem), 100–250 μL (chem), 120–200 μL (immuno)/1 μL (chem), 75 μL/1.5 μL (chem), 4 μL (immuno)/50 μL
4–10 μL (immuno)/500 or 1,000 μL (tube dependent) 4–10 μL (immuno)/50–1,000 µL (container dependent)
Dedicated pediatric sample cup yes (dead volume: 50 µL) yes (dead volume: 50 µL) yes (dead volume: 50 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes yes/yes yes/yes (11 × 102 mm [chem], 13 × 102 mm [immuno])
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes yes
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots quantitation for hemolysis, icterus, lipemia; detection for clots quantitation for hemolysis, icterus, lipemia; detection for clots
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to analysis)/ yes (can be programmed to perform dilutions prior to analysis)/ yes (can be programmed to perform dilutions prior to analysis)/
< 1 part per million (chemistry), no carryover (immunoassay) <1 part per million (chemistry), no carryover (immunoassay) <1 part per million (chemistry), no carryover (immunoassay)
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes yes yes
low results
Analyzer requires dedicated water supply yes (10 L/hr. consumption during operation for chemistry, yes (10–36 L/hr. consumption during operation for chemistry, yes (32 L/hr. consumption during operation for chemistry,
12 L/hr. for immunoassay) 12–30 L/hr. for immunoassay) 30 L/hr. for immunoassay)
Autocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/yes (recommended yes (calibrants are not stored onboard)/yes (recommended yes (calibrants are not stored onboard)/yes (recommended avg.
avg. frequency: 24 hrs. [ISE], once per lot [chemistry], avg. frequency: 24 hrs. [ISE], once per lot [chemistry], frequency: once per lot [chem], up to 84 days per lot [immuno])
up to 56 days per lot [immunoassay]) up to 84 days per lot [immunoassay])
Typical calibration frequency for ISE/therapeutic drugs/ 24 hrs./once per lot/42 days per lot/once per lot/up to 56 24 hrs./once per lot/42 days per lot/once per lot/up to 84 once per lot/once per lot/once per lot/once per lot/up to 84
drugs of abuse/general chemistries/immunoassays days per lot days per lot days per lot
Automatic programmable start/Automatic programmable shutdown yes/yes yes (6.5 min. start-up time)/yes yes (6.5 min. start-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management direct to drain direct to drain direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer yes yes yes
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes yes
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/SCC, Meditech, Cerner, Epic, Sunquest, more onboard, optional add-on (Bio-Rad MAS)/SCC, Cerner, Epic, more
LIS interface provided/Bidirectional interface capability yes (incl. in instrument price)/yes (broadcast download and host query) yes (incl. in instrument price)/yes (broadcast download and host query) yes (incl. in price)/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time yes/< 8 hrs. yes/< 8 hrs. yes/—
Mean time between failures avg. 259 days per module (displays error codes for troubleshooting) avg. 152 days per module (displays error codes for c 503 module: 220 days; e 801 module: avg. 220 days
troubleshooting) (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 4 min.; weekly: 20 min.; monthly: 35 min. daily: 4–5 min.; weekly: 20 min.; monthly: 25 min. daily: ~5 min.; weekly: 0 min.; monthly: ~59 min.
Maintenance records kept onboard for user/vendor yes/yes (both include audit trail of who replaced parts) yes/yes (both include audit trail of who replaced parts) yes/yes (both include audit trail of who replaced parts)
Maintenance training demonstration module onboard yes yes yes
Training included with purchase/Avg. time for basic user training yes (2 training slots)/varies at customer site, 5 days at yes (4 training slots)/varies at customer site, 5 days at yes (~ 2 training slots per module)/~5 days (at customer
vendor site vendor site and vendor sites)
Advanced operator training/Extra charge for follow-up yes (at vendor site)/yes yes (at vendor site)/yes (cost varies by contract) yes (at vendor site)/yes (cost varies by contract)
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/configuration dependent yes (1 year)/configuration dependent yes (1 year)/varies by contract
Distinguishing features (supplied by company) • broad test menu: > 180 assays on one integrated platform • high reagent onboard and calibration stability; no reagent •m  inimal operator intervention with automated maintenance,
• flexible, scalable design: available in seven unique prep; on-the-fly loading automated calibration, and continuous loading of reagents
configurations • broad test menu: > 180 assays on one integrated platform • long onboard reagent (up to 6 months) and calibration stabilities
Note: a dash in lieu of an answer means company • increase revenue through expanded testing services with broad
did not answer question or question is not applicable menu on consolidated platform and fast incubation times

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 63

Part 13 of 16 Siemens Healthineers Siemens Healthineers Siemens Healthineers

Leslie Rau [Link]@[Link] Tony Gaglio [Link]@[Link] Rachel Forsaith [Link]@[Link]
forMID– and HIGH–VOLUME Tarrytown, NY Tarrytown, NY Tarrytown, NY
LABORATORIES 800-888-7436 [Link]/en-us 800-888-7436 [Link]/en-us 800-888-7436 [Link]/en-us
Name of instrument Atellica Solution Analyzer Atellica CI Analyzer IMMULITE 2000 XPi Immunoassay System
Type of instrument combination chemistry/immunoassay combination chemistry/immunoassay immunoassay
Operational type/Model type batch, random access, continuous random access, batch, random access, continuous random access, batch, random access, continuous random access,
discrete/floor standing discrete/floor standing discrete/floor standing
List price/First year sold in U.S. —/2017 —/2023 —/2009
Targeted hospital bed size/Targeted test volume —/annual: > 1 million —/annual: 250,000 –1 million > 200/daily: > 250
Company manufactures instrument yes (also sold by McKesson, Henry Schein, Medline) yes (also sold by McKesson, Henry Schein, Medline, Fisher) yes (also sold by McKesson, Henry Schein, Medline)
Other models in this family of analyzers Atellica CH 930, IM 1300, IM 1600 — —
No. of units in clinical use in U.S./Outside U.S. (countries) — — ≥ 550/≥ 2,400 (> 75 countries)
Dimensions (H × W × D)/Instrument footprint chem: 53.7 × 58.6 × 45.5 in.; immuno: 59.1 × 56.9 × 45.0 in./ 63.0 × 80.1 × 36.8 in./20.4 sq. ft. 47 × 60 × 30 in./—
64.6 sq. ft.
Weight empty/Weight fully loaded chem: 1,036 lbs.; immuno: 1,265 lbs./— 1,675 lbs./— 800 lbs./—
No. of different measured assays onboard simultaneously chem: up to 70; immuno: up to 42 chem: up to 45 (45 can be run and calibrated at one time); 24
immuno: up to 20 (20 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels — 25 (25 can be active simultaneously) none
Test throughput per hour/Assay run time chem: up to 1,800; immuno: up to 440 (up to 2,240 tests in chem: up to 1,000 (600 photometric, 400 electrolyte tests in up to 200 (200 tests in throughput)/—
throughput)/10–54 min. throughput); immuno: up to 120 (assay dependent)/
24 sec.–54 min. (avg. 14 min.)
Chemistry:
No. of direct ion-selective electrode channels 3 3 —
Detection methods photometry, potentiometry, turbidimetric, EMIT photometry, potentiometry, turbidimetric, EMIT —
Stat time until completion/specimen throughput for:
• Ion-selective electrode 18–27 sec./— 24 min./— —
• Basic metabolic panel 10 min./— 10 min./— —
• Complete metabolic panel 10 min./— 10 min./— —
Typical time delay from ordering stat test until aspiration of sample 60 sec. maximum 60 sec. maximum —
Immunoassay:
Fully automated microplate immunoassay system no no no
Methodologies supported chemiluminescence, acridinium ester chemiluminescence chemiluminescence, acridinium ester chemiluminescence enzyme-amplified chemiluminescence
Separation methodologies magnetic particle magnetic particle bead
Stat time until completion of a ß-hCG test 10 min. 10 min. 35 min.
• Typical time delay from test order to aspiration of sample 60 sec. maximum 60 sec. maximum 18 sec.
Stat time until completion of a cTn test 10 min. 10 min. 35 min.
• Typical time delay from test order to aspiration of sample 60 sec. maximum 60 sec. maximum 18 sec.
Approximate No. of tests per reagent set/Reagent type 50–8,000 (assay dependent)/self-contained multiuse, open 95–2,100 (assay dependent)/self-contained multiuse, open 200/self-contained multiuse
reagent system reagent system
Reagents refrigerated onboard/Reagents ready to use yes (4°–8°C)/yes yes (4°–10°C)/yes yes (2°–8°C)/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes liquid chemistry (open reagent system)/yes liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/no
Walkaway capability/Walkaway duration yes/300 min. or 9,000 tests (chem), 450 min. or 1,200 tests (immuno) yes/120 min. or 2,000 tests (chem), 240 tests (immuno) yes/up to 300 min.
Design of sample-handling system multiple rack drawer rack rack
Uses washable cuvettes/Uses disposable cuvettes yes/yes (can store up to 221 cuvettes for chem, up to 1,200 yes/yes (can store up to 194 cuvettes for chem, up to 856 no/yes (can store up to 1,300 cuvettes)
for immuno) for immuno)
Min.–max. sample volume that can be aspirated at one time 2–50 µL (chem),10–200 µL (immuno) 2–100 µL (assay dependent) 5–600 µL
Min. reaction volume/Min. specimen volume/Min. dead volume assay dependent/assay dependent/container dependent 10–100 µL/2 µL/— —/5 µL/50 µL
Dedicated pediatric sample cup no no yes (dead volume: 50 µL)
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes yes/yes (8 × 31.37 mm) yes/yes (12–16 × 75–100 mm; 10 × 50 mm micro sample
tube sizes tubes)
Pierces caps on primary tubes — no no
Protects against probe collision yes yes no
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to analysis)/­— yes (can be programmed to perform dilutions prior to yes (can be programmed to perform dilutions prior to analysis)/
analysis)/no < 3 parts per million
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes — no
low results
Analyzer requires dedicated water supply yes (33 L/hr. consumption during operation for chemistry, yes (25 L/hr. consumption during operation for chem, no
6 L/hr. for immunoassay) immuno combined)
Autocalibration/Multipoint calibration supported yes (calibrants can be stored onboard)/yes (recommended yes (calibrants are not stored onboard)/yes (recommended avg. yes (calibrants are not stored onboard)/yes (recommended
avg. frequency: 28–183 days [chem], 14–91 days [immuno]) frequency: 28–183 days [chem], 14–91 days [immuno]) avg. frequency: 1–4 weeks [assay dependent])
Typical calibration frequency for ISE/therapeutic drugs/ every 4 hrs./28–63 days/40–180 days/up to 180 days/ every 4 hrs./every 28–63 days/40–180 days/up to 180 days/ —/2 weeks/—/—/1–4 weeks (assay dependent)
drugs of abuse/general chemistries/immunoassays 14–91 days 14–91 days
Automatic programmable start/Automatic programmable shutdown yes/yes yes/no — (4 min. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes yes
Waste management manually by user or direct to drain manually by user, automated collection onboard instrument, manually by user
direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer yes yes no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring yes yes no
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced optional add-on (Siemens Atellica Data Manager)/yes optional add-on (Siemens Atellica Data Manager)/yes optional add-on (Siemens CentraLink Data Manager)/yes
LIS interface provided/Bidirectional interface capability yes (incl. in price)/yes (broadcast download and host query) yes (incl. in price)/yes (broadcast download and host query) yes/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time yes/5 hrs. avg. yes/— yes/2–8 hrs.
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: < 5 min.; weekly: 10–15 min.; monthly: 10–15 min. daily: < 5 min.; weekly: < 5 min.; monthly: < 15 min. daily: 5–10 min.; weekly: 20 min.; monthly: 20–30 min.
Maintenance records kept onboard for user/vendor yes/yes (both include audit trail of who replaced parts) yes/yes (both include audit trail of who replaced parts) no/no
Maintenance training demonstration module onboard yes yes yes
Training included with purchase/Avg. time for basic user training yes (3 training slots)/6.5 days (at customer and vendor sites) yes (3 training slots)/1–3 days (at customer site) yes (2 training slots)/3 days (at customer and vendor sites)
Advanced operator training/Extra charge for follow-up — yes (at vendor site)/no yes (at vendor site)/contract dependent
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/— yes (1 year)/— yes (1 year)/—
Distinguishing features (supplied by company) • p atented Atellica Magline bidirectional sample transport • integrated chem/immuno technologies share no major • extensive routine and specialty immunoassay menu;
uses individual sample carriers for rapid throughput common components includes menu of more than 300 allergens
• a utomated high-capacity calibration and chemistry QC • true random-access sampling via independent CH/IA probes • specific allergens and panels; provides opportunity to
processing materials stored onboard with auto deployment • standardized user interface across Atellica portfolio reduce sendouts and boost revenue
• microvolume sample technology for CC; IA controlled temperature • reagent onboard stability of 90 days
Note: a dash in lieu of an answer means company requires no recalibration if laboratory ambient temp. changes
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
64 CAP TODAY | JULY 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS

Part 14 of 16 Thermo Fisher Scientific/BRAHMS Thermo Fisher Scientific Tosoh Bioscience

[Link]@[Link] Jessica Murphy [Link]@[Link] [Link]@[Link]
forMID– and HIGH–VOLUME Hennigsdorf, Germany Portage, MI Grove City, OH
LABORATORIES +49(0)33028830 [Link]/kryptor 800-346-4363 [Link]/phadia 800-248-6764 [Link]
Name of instrument B⋅R⋅A⋅H⋅M⋅S KRYPTOR GOLD Phadia 250 Laboratory System AIA-900
Type of instrument immunoassay immunoassay immunoassay
Operational type/Model type batch, random access, continuous random access/ continuous random access, discrete/floor standing continuous random access/floor standing
benchtop
List price/First year sold in U.S. — —/2004 —/2011
Targeted hospital bed size/Targeted test volume —/daily: 600; monthly: 12,000; annual: 156,000 —/annual: > 20,000–95,000 —/monthly: 500–1,500
Company manufactures instrument yes (also sold by distribution partners) no (manufactured by Hitachi) yes
Other models in this family of analyzers B⋅R⋅A⋅H⋅M⋅S KRYPTOR compact PLUS Phadia 1000, Phadia 2500, Phadia 5000 Laboratory Systems AIA-360, AIA-2000
No. of units in clinical use in U.S./Outside U.S. (countries) —/— (worldwide) > 260/> 2,135 ~350/> 1,200 (worldwide)
Dimensions (H × W × D)/Instrument footprint 28.74 (47.64 with tower light or open hood) × 36.61 × 73 × 50 × 30 in. plus 26-in. wide computer stand/ 49 × 35 × 26 in. (loader), 49 × 51 × 26 in. (9-tray sorter),
28.34 in./55.11 in. 54 sq. ft. 49 × 60 × 26 in. (19-tray sorter)/—
Weight empty/Weight fully loaded 260 lbs./— 485 lbs./— 404 lbs. (loader), 562 lbs. (9-tray sorter), 602 lbs. (19-tray
sorter)/—
No. of different measured assays onboard simultaneously 16 (16 can be run and calibrated at one time) 6 (6 can be run and calibrated at one time) 45
No. of user-definable (open chemistry) channels — 0 0
Test throughput per hour/Assay run time 115 (up to 115 tests in throughput)/9–59 min. 60 tests/100 min. 90/—
Chemistry:
No. of direct ion-selective electrode channels — — —
Detection methods — — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — —
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample — — —
Immunoassay:
Fully automated microplate immunoassay system no no —
Methodologies supported fluorescence, enzyme immunoassay fluoroenzyme immunoassay fluorescence
Separation methodologies none necessary fiber matrix filter, coated microwell —
Stat time until completion of a ß-hCG test 14 min. — 20 min.
• Typical time delay from test order to aspiration of sample 2 min. — —
Stat time until completion of a cTn test — — 20 min.
• Typical time delay from test order to aspiration of sample — — —
Approximate No. of tests per reagent set/Reagent type 50–100/self-contained multiuse varies/self-contained multiuse 100/unit dose test cup
Reagents refrigerated onboard/Reagents ready to use yes (2°–8°C)/yes yes (2°–8°C for conjugates, ImmunoCAP, EliA wells; others no/yes
at room temperature)/variable; reagent specific
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/no
Reagent form/Reagents barcoded liquid chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/yes dry chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no yes/—
Walkaway capability/Walkaway duration yes/430 min. or 18 specimens or 419 tests yes/100 min. yes/~ 2 hours or 45 specimens or 45 tests
Design of sample-handling system sample cassette placed in sample carousel rack rack
Uses washable cuvettes/Uses disposable cuvettes no/no no/no no/no
Min.–max. sample volume that can be aspirated at one time 8–70 µL 20–40 μL 2–100 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 150 µL/sample tube and assay dependent/150 µL sample 40 μL (ImmunoCAP), 20 μL (EliA)/—/150 μL 10 µL/110 µL/100 µL
tube dependent
Dedicated pediatric sample cup yes (dead volume: 75 µL) no no
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/yes (11–17 × 60–120 mm) yes/— yes/—
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision no yes —
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available —
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to analysis)/ yes/— no/no carryover
≤ 2 parts per million (no contamination)
Automatic rerun capability yes no yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range yes no no
low results
Analyzer requires dedicated water supply no no (1 L/hr. consumption during operation) no
Autocalibration/Multipoint calibration supported yes (calibrants are not stored onboard)/no yes (calibrants are stored onboard)/yes (recommended avg. no (calibrants are stored onboard)/yes
frequency: 28 days)
Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/5–15 days —/—/—/—/28 days —/—/—/—/most assays are 90 days
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no yes/yes no (5 min. warm-up time)/no
Onboard real-time QC/Onboard software capability to review QC yes/yes yes/yes no/no
Supports multiple QC lot numbers per analyte yes yes yes
Waste management manually by user or automated collection onboard instrument automated collection onboard instrument or direct to drain automated collection onboard instrument
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, Code 93, yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, JAN)/yes
EAN-8, Industrial 2 of 5, COOP 2 of 5)/no
Lab can control analyzer from remote computer no no no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) no
System malfunctions can be diagnosed via remote monitoring yes yes —
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced onboard/— onboard/Antek, Cerner, Data Innovations, Epic, GE TriplerG, optional add-on (Tosoh 501RP+)/—
McKesson, Meditech, NetLIMS, more
LIS interface provided/Bidirectional interface capability yes (additional cost)/yes (broadcast download and host query) —/yes (broadcast download and host query) no/yes (host query)
Modem servicing provided/Service engineer on-site response time yes/Mon.–Fri.: 26 hrs. at total breakdown, 72 hrs. at workaround no/24 business hrs. —
Mean time between failures — (displays error codes for troubleshooting) — (displays error codes for troubleshooting) 354 days (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 3 min.; weekly: 3 min.; monthly: 5 min. daily: 5 min.; weekly: 10 min.; monthly: 3 hrs. daily: 10 min.; weekly: 15 min.; monthly: 15 min.
Maintenance records kept onboard for user/vendor yes/yes (both include audit trail of who replaced parts) some records (date of instrument maintenance)/no no/no
Maintenance training demonstration module onboard no no no
Training included with purchase/Avg. time for basic user training yes (1 training slot)/1.5–2 days (at customer site) yes (2 training slots)/4 days (vendor site preferred, at yes/2.5 days (at vendor site)
customer site on request)
Advanced operator training/Extra charge for follow-up yes (at vendor site)/yes yes (at vendor site)/— no/—
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year)/contract dependent yes (1 year)/— yes (1 year from installation date)/—
Distinguishing features (supplied by company) • fully automated random-access immunoanalyzer with • collection of high-quality, clinically relevant autoimmune disease • unit dose test cup; dry reagent, no premixing or reagent
unique Nobel Prize–winning TRACE technology tests with the ability to run allergy and autoimmune tests in the preparation
• automated timely onboard dilution in less than 5 minutes same run • no interference from biotin; broad menu with fast results
Note: a dash in lieu of an answer means company with integrated self-determining dilution factor • broad specific IgE whole allergen and allergen component menu • 90-day calibration stability for most assays
did not answer question or question is not applicable • no biotin interferences of the assays • master isotype calibration curves

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
 CHEMISTRY and IMMUNOASSAY ANALYZERS JULY 2024 | CAP TODAY 65

Part 15 of 16 Tosoh Bioscience Werfen Werfen

[Link]@[Link] Edward Bass [Link]@[Link] Liliana Penaranda [Link]@[Link]
forMID– and HIGH–VOLUME Grove City, OH San Diego, CA San Diego, CA
LABORATORIES 800-248-6764 [Link] 858-586-9900 [Link] 858-586-9900 [Link]
Name of instrument AIA-2000 Aptiva BIO-FLASH
Type of instrument immunoassay immunoassay immunoassay
Operational type/Model type continuous random access/floor standing random access, continuous random access/benchtop continuous random access/benchtop
List price/First year sold in U.S. —/2008 —/2021 —/2012
Targeted hospital bed size/Targeted test volume > 65/monthly: > 1,500 200/daily: 150; monthly: 3,000; annual: 36,000 —
Company manufactures instrument yes (also sold by McKesson, Henry Schein, Thermo Fisher, yes yes
Medline)
Other models in this family of analyzers AIA-360, AIA-900 — —
No. of units in clinical use in U.S./Outside U.S. (countries) ~80/> 1,000 (worldwide) —/50 —/1,000
Dimensions (H × W × D)/Instrument footprint AIA-2000 ST: 50 × 59 × 35 in./AIA-2000 LA: 50 × 59 × 47 in./ 30 × 60 × 24 in./10 sq. ft. 21 × 34 × 24 in./—
14.6 sq. ft.
Weight empty/Weight fully loaded 882 lbs./— 275 lbs./285 lbs. 170 lbs./—

No. of different measured assays onboard simultaneously 48 (48 can be run and calibrated at one time) 20 (20 can be run and calibrated at one time) 20 (20 can be run and calibrated at one time)
No. of user-definable (open chemistry) channels 0 0 0
Test throughput per hour/Assay run time 200 (18 min. to first result, 18 sec. for subsequent up to 720/30 min. 60 (60 tests in throughput)/30 min.
results)/18–58 min. (avg. 38 min.)
Chemistry:
No. of direct ion-selective electrode channels — — —
Detection methods — — —
Stat time until completion/specimen throughput for:
• Ion-selective electrode — — —
• Basic metabolic panel — — —
• Complete metabolic panel — — —
Typical time delay from ordering stat test until aspiration of sample — — —
Immunoassay:
Fully automated microplate immunoassay system no no no
Methodologies supported fluorescence, enzyme immunoassay fluorescence chemiluminescence
Separation methodologies magnetic particle, bead magnetic particle magnetic particle, bead
Stat time until completion of a ß-hCG test 18 min. — —
• Typical time delay from test order to aspiration of sample 18 sec. — —
Stat time until completion of a cTn test 18 min. — —
• Typical time delay from test order to aspiration of sample 18 sec. — —
Approximate No. of tests per reagent set/Reagent type 100–200 (varies by assay)/self-contained single use 100–250/self-contained multiuse 50–100/self-contained multiuse
Reagents refrigerated onboard/Reagents ready to use no/yes yes (5°C)/yes yes/yes
Reagent lot tracking/Reagent inventory yes/yes yes/yes yes/yes
Reagent form/Reagents barcoded dry chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/yes liquid chemistry (closed reagent system)/yes
Separate reagent pack for each specimen/for each test run no/no no/no no/yes
Walkaway capability/Walkaway duration yes/~3 hours or 200 specimens or 960 tests yes/6.5 hrs. yes/30 specimens or 140 tests
Design of sample-handling system rack rack rack
Uses washable cuvettes/Uses disposable cuvettes no/no no/yes (can store up to 728 cuvettes) no/yes (can store up to 280 cuvettes)
Min.–max. sample volume that can be aspirated at one time 2–100 µL 10–100 µL 4–250 µL
Min. reaction volume/Min. specimen volume/Min. dead volume 10 µL/10 µL/100 µL 10 µL/10 µL/50 µL 20 µL/5 µL/200 µL
Dedicated pediatric sample cup no no yes
Primary tube sampling yes yes yes
Accommodates most standard tube sizes/Accepts nonstandard yes/no yes/yes yes/no
tube sizes
Pierces caps on primary tubes no no no
Protects against probe collision yes yes no
Detects clots/liquid level/short sample yes/yes/yes yes/yes/yes yes/yes/yes
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available detection for clots; hemolysis, icterus, lipemia not available —
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to no/— yes (can be programmed to perform dilutions prior to
analysis)/— analysis)/—
Automatic rerun capability yes yes yes
Sample volume can be diluted to rerun out-of-linear-range high results yes yes yes
Sample volume can be concentrated to rerun out-of-linear-range no yes no
low results
Analyzer requires dedicated water supply no no no
Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes (recommended yes (calibrants can be stored onboard)/yes no (calibrants are not stored onboard)/yes
avg. frequency: 90 days)
Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/90 days —/—/—/—/each lot or 6 months —/—/—/—/once per year
drugs of abuse/general chemistries/immunoassays
Automatic programmable start/Automatic programmable shutdown no/no yes (10 min. warm-up time)/yes yes (5 min. warm-up time)/yes
Onboard real-time QC/Onboard software capability to review QC no/yes yes/yes yes/yes
Supports multiple QC lot numbers per analyte yes yes no
Waste management automated collection onboard instrument or direct to drain automated collection onboard instrument or direct to drain automated collection onboard instrument or direct to drain
Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, Codabar, Code 39, Code 128, JAN)/yes yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128)/yes yes (Interleaved 2 of 5, Codabar, Code 39, Code 128)/yes
Lab can control analyzer from remote computer no no no
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) no (operator intervention required to order parts) no (operator intervention required to order parts)
System malfunctions can be diagnosed via remote monitoring no yes no
UPS backup power supply yes yes yes
Data-management capability/LIS or EHR systems interfaced onboard/Orchard, Data Innovations, Sunquest, Cerner, onboard/Cerner, Sunquest, Meditech onboard/—
MedLab, SCC Soft Computer, SchuyLab, IDEAS, more
LIS interface provided/Bidirectional interface capability no/yes (host query) yes/yes (broadcast download and host query) no/yes (broadcast download and host query)
Modem servicing provided/Service engineer on-site response time no/within 24 hours yes/12 hrs. no/24 hrs.
Mean time between failures 106 days (displays error codes for troubleshooting) 180 days (displays error codes for troubleshooting) — (displays error codes for troubleshooting)
Average scheduled maintenance time by lab personnel daily: 5 min.; weekly: 5 min.; monthly: 10 min. daily: 10 min.; weekly: 15 min.; monthly: 20 min. daily: performed automatically; weekly: 5 min.; monthly: 15 min.
Maintenance records kept onboard for user/vendor yes/yes (both include audit trail of who replaced parts) yes/yes (includes audit trail of who replaced parts) some records/some records
Maintenance training demonstration module onboard no yes no
Training included with purchase/Avg. time for basic user training yes (2 training slots)/4 days (at vendor site) yes (2 training slots)/3 days (at customer site) yes/3 hrs. (at customer site)
Advanced operator training/Extra charge for follow-up no/— yes (at customer site)/no yes (at customer or vendor site)/—
or advanced training
Warranty provided/Cost of annual service contract (24 h/7 d) yes (1 year from installation date)/— yes (1 year)/— yes/—
Distinguishing features (supplied by company) • dry reagent with no biotin interference, unit dose test cup, • multianalyte system allows simultaneous analysis of up to • improves laboratory workflow and productivity; eliminates
90-day calibration stability for most assays 12 analytes batching and reagent waste with stable onboard reagents
• 3 separate incubators to minimize processing time; dual • introduces novel analytes to improve utility of autoimmune • provides simultaneous random-access processing of all
clot detection, automated dilutions, and pretreament diagnosis isotypes and assays from one sample on a single run
• available in 2 models–standard (ST) and line automation • 6.5 hour consumable walkaway time; generates up to 720 • delivers results, including stat orders, in as little as 30
(LA)–appropriate for stat and routine use results per hour minutes; minimal hands-on time for user maintenance
Note: a dash in lieu of an answer means company
did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
66 CAP TODAY | JULY 2024
CHEMISTRY and IMMUNOASSAY ANALYZERS

CAP TODAY product guides

Part 16 of 16 Werfen
Edward Bass [Link]@[Link]
forMID– and HIGH–VOLUME San Diego, CA
LABORATORIES 858-586-9900 [Link]
help you weigh your options when
Name of instrument QUANTA-Lyser 3000
Type of instrument immunoassay it's time for a new instrument
Operational type/Model type batch/benchtop
List price/First year sold in U.S.
Targeted hospital bed size/Targeted test volume
—/2017
—
or software system
Company manufactures instrument —
Other models in this family of analyzers —
No. of units in clinical use in U.S./Outside U.S. (countries) — 28 CAP TODAY | APRIL 2024

Part 1 of 3
BILLING/ACCOUNTS RECEIVABLE/RCM SYSTEMS

Advanced Data Systems Corp.

Marc Klar [Link]@[Link]
CompuGroup Medical
Patrick Hall [Link]@[Link]
Cortex Medical Management Systems
Carrie Cohen ccohen@[Link]
Paramus, NJ Austin, TX Seattle, WA
800-899-4237 ext. 2264 [Link] 877-564-4414 [Link]/us 206-812-6981 [Link]

Dimensions (H × W × D)/Instrument footprint 36.6 × 45.3 × 32 in./—

Name of billing/accounts receivable/revenue cycle management system MedicsPremier CGM SCHUYLAB† Cortex Medical Billing RCM
How billing/AR/RCM functionality is deployed remote hosting or local server and software (client option) local server and software remote hosting or local server and software (client option)
Configuration of billing/AR/RCM system available as a standalone product designed to interface available as an integrated component of CompuGroup available as a standalone product designed to interface
with any company’s LIS and EHR Medical’s clinical LIS with any company’s LIS and EHR
How updates to billing/AR/RCM system are covered via standard software maintenance fee via standard software maintenance fee via standard software maintenance fee

Weight empty/Weight fully loaded 462 lbs./—

Year company began selling billing/AR/RCM systems 1977 (began selling MedicsPremier in 1998) 1990 (began selling CGM SCHUYLAB in 2020) 1983 (began selling Cortex Medical Billing RCM in 1983)
Most recent billing/AR/RCM system client go-live (based on Feb. 2024 survey deadline) January 2024 January 2024 —
Last product release or update of featured billing/AR/RCM system September 2023 (version 10.0) July 2023 (version 4.0) October 2023 (version 10.2.18)
No. of contracts for sites using billing/AR/RCM system 251 110 44
• No. of sales of billing/AR/RCM system between Feb. 2023–Jan. 2024 31 4 2
• No. of clients that went live with billing/AR/RCM system, Feb. 2023–Jan. 2024 20 4 2

No. of different measured assays onboard simultaneously 12–22 (12–22 can be run and calibrated at one time)
No. of sites operating billing/AR/RCM system that are hospital labs in U.S./ 0/251 (85 AP labs + 46 molecular or NGS labs + 74 4/75 (5 AP labs+5 molecular or NGS labs+45 clinical 0/43 (42 AP labs+1 other U.S. site–hospital ER)/0
commercial medical (nonhospital) sites in U.S.*/foreign medical sites clinical reference labs + 14 physician office labs + 32 reference labs+10 physician office labs+10 other
other U.S. sites–toxicology, esoteric labs)/0 U.S. sites–veterinary, independent reference labs)/31–
independent reference labs, physician office labs, hospitals
Company actively markets billing/AR/RCM system outside the U.S. no yes (in Guam, Caribbean, Canada, Africa, Pacific Rim, no

No. of user-definable (open chemistry) channels — (12–22 can be active simultaneously)

South East Asia)
• Foreign locations in which billing/AR/RCM system is installed none Guam, Caribbean, Canada, Africa, Pacific Rim, South —
East Asia
Human languages (other than English) supported by system none Spanish, Portuguese, Chinese, Italian, Japanese, French —
German, Dutch
No. of invoices handled by installed sites annually — 100–1,000,000+ —

Test throughput per hour/Assay run time assay dependent/—

No. of requisitions handled by installed sites annually — 100–1,000,000+ —
No. of users who have access to system in smallest site/in largest site 6/148 1/65 1/30
Approximate No. of employees in entire company 300 1,650 10
Company provides list of client sites to potential customers on request yes (partial list of comparable sites but prospective client yes (list of customers who have agreed to speak with yes (with permission from existing clients)
must sign a nondisclosure agreement) prospective clients)
Programming languages and development applications or environments C++, SQL, Caché C++ .Net
Operating systems Microsoft Windows Microsoft Windows —

Chemistry:
Databases Caché, SQL FairCom C-Tree Microsoft SQL
Functionality incorporated in product:
• Generates CMS 1500 (HCFA-1500) claim form (paper version) installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Generates UB-04 (CMS 1450) claim form (paper version) installed at laboratory sites installed at laboratory sites —
• Generates client invoices/Generates patient invoices/Generates family invoices installed at laboratory sites (all three features) installed at laboratory sites (all three features) installed at laboratory sites (all three features)

No. of direct ion-selective electrode channels —

• Guarantor billing installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Ability to produce a GAAP, FASB, and SOX-compliant end-of-month installed at laboratory sites — —

D ng m nd w h u n ng
financial package with referential integrity
• Billing by test profile/Component billing installed at laboratory sites (both features) installed at laboratory sites (both features) installed at laboratory sites (both features)
• Medical-necessity screening for Medicare installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Ability to split technical component and professional component and bill separately installed at laboratory sites installed at laboratory sites installed at laboratory sites

Detection methods —
• Prevents billing for nonbillable procedures installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Patient demographic data transferred via interface from LIS or EHR to billing system installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Retains demographic data for repeating patients installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Account and patient payment posting/Full accounts receivable functionality installed at laboratory sites (both features) installed at laboratory sites (both features) installed at laboratory sites (both features)
• Credit card processing installed at laboratory sites not available for this software available via a third party
• Automatic balance billing to patient after receiving remittance that satisfies installed at laboratory sites installed at laboratory sites installed at laboratory sites

Stat time until completion/specimen throughput for:

CPT codes on insurance
• Ability to fee-for-service bill tests and codes carved out of capitated plans installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Generates utilization reports for managed care installed at laboratory sites installed at laboratory sites —
• Generates global charges for lab tests installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Ability to set an unlimited No. of user-defined fee schedules installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Ability to separate payers into lab-defined groups and report on the groups installed at laboratory sites installed at laboratory sites installed at laboratory sites

• Ion-selective electrode —
• Displays expected reimbursement by payer installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Allows open-item accounting installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Client services or call tracking module installed at laboratory sites not available for this software —
• Benefit eligibility checking with auto-update installed at laboratory sites not available for this software available via a third party
• User-defined patient dunning cycles/User-defined patient collections process installed at laboratory sites (both features) installed at laboratory sites (both features) installed at laboratory sites (both features)
• User report writer installed at laboratory sites installed at laboratory sites installed at laboratory sites

• Basic metabolic panel —

• Client control of software edits for preferences and configurations installed at laboratory sites installed at laboratory sites —
• Client control of payer-specific rules and configurations installed at laboratory sites installed at laboratory sites installed at laboratory sites
• Ability to audit activity per user/Ability to measure productivity per user installed at laboratory sites (both features) installed at laboratory sites (both features) installed at laboratory sites (both features)
• Storage and management of supporting documentation for claims and appeals installed at laboratory sites not available for this software —
• Automated workflow for identifying errors up front and addressing them prior installed at laboratory sites installed at laboratory sites installed at laboratory sites
to claim submission

• Complete metabolic panel —

• Appeals tracking/Appeals success metrics installed at laboratory sites (both features) not available for this software (both features) —
• Underpayment tracking/Key indicator tracking installed at laboratory sites (both features) installed at laboratory sites/not available for this software installed at laboratory sites (both features)
• Generates financial reports/Generates operational reports installed at laboratory sites (both features) installed at laboratory sites (both features) installed at laboratory sites (both features)
• Reports client performance in terms of payment rates, denials, similar metrics installed at laboratory sites installed at laboratory sites installed at laboratory sites
• AI-enabled analytics that support workflow automation and configuration installed at laboratory sites not available for this software —

Typical time delay from ordering stat test until aspiration of sample —
Portals provided on billing/AR/RCM system client/physician Web portal, patient service center Web client/physician Web portal, patient service center Web none
portal, patient Web portal, sales portal portal, patient Web portal
Means by which billing/AR/RCM system tracks profitability test, payer, client (user’s choice) functionality not provided test, payer, client (user’s choice)
Advanced system capabilities rules-based processing, claims scrubbing, bundling/ rules-based processing, claims scrubbing, bundling/ rules-based processing, claims scrubbing, bundling/
unbundling, 72-hour rule, 14-day rule unbundling, 72-hour rule, 14-day rule unbundling, 72-hour rule, 14-day rule
Voluntary coding systems, standards, or formats supported ICD-10, CPT, HCPCS level II ICD-10, CPT, HIPAA transaction sets, X12 5010A1 ICD-10, CPT, HCPCS level II
System supports EDI with third-party payers and claims clearinghouses yes (with Change Healthcare; 100% of data exchange yes (with eMedix, Office Ally, ProxyMed, Ontario Health yes (99% of data exchange via direct electronic
via direct electronic connection) Insurance Plan; 100% of data exchange via direct connection)
electronic connection)

Immunoassay:
Code changes automatically accepted by billing/AR/RCM system via interfaces yes (if codes provided in CSV format) yes (using CodeMap) —
Billing/AR/RCM system provides indexed field in each test definition for LOINC code yes yes no
Client gets copy of source code/User group that meets on established schedule escrow/— escrow/no —/yes (in person and via webinar)
Methods by which users can tailor billing/AR/RCM system in their own setting ad hoc query tools, user-defined interfaces, workflow user-defined interfaces, workflow configuration user-defined interfaces, dictionary settings, read/write
configuration, tailored worklists privileges

Fully automated microplate immunoassay system yes (1 test per well; 96 wells per microplate)
Qualified users or third parties can modify or augment standard yes (client users) yes (client users) no (all modifications made by vendor)
billing/AR/RCM system functionality or features
Distinguishing product features (supplied by company) • supports an option for insurance discovery for
patients who don’t have insurance coverage listed
• supports a built-in sales portal that allows a lab’s
* breakdown of commercial medical (nonhospital) sites generalized

Methodologies supported enzyme immunoassay

sales team to self-serve
Note: A dash in lieu of an answer means company did not answer
question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. Product guide editors: Raymond D. Aller, MD, and Dennis Winsten All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.

Separation methodologies coated microwell APRIL 2024 page 28 APRIL 2024 page 29

Stat time until completion of a ß-hCG test —

• Typical time delay from test order to aspiration of sample —
Stat time until completion of a cTn test —
• Typical time delay from test order to aspiration of sample —
Approximate No. of tests per reagent set/Reagent type 96–240/open reagent system
Reagents refrigerated onboard/Reagents ready to use no/yes
Reagent lot tracking/Reagent inventory yes/no 36

Reagent form/Reagents barcoded liquid chemistry (open reagent system)/yes

Separate reagent pack for each specimen/for each test run
Walkaway capability/Walkaway duration
no/yes
yes/300 min. or 240 specimens or 540 tests VISIT
Design of sample-handling system
Uses washable cuvettes/Uses disposable cuvettes
rack
no/no
[Link]
Min.–max. sample volume that can be aspirated at one time
Min. reaction volume/Min. specimen volume/Min. dead volume
5–1,000 µL
30 µL/5 µL/200 µL
and select the product guide tab
Dedicated pediatric sample cup
Primary tube sampling
no
yes to view these guides:
Accommodates most standard tube sizes/Accepts nonstandard yes/no
tube sizes
Pierces caps on primary tubes no INSTRUMENTS • Bedside glucose testing systems • Chemistry and
Protects against probe collision no
Detects clots/liquid level/short sample yes/yes/yes
immunoassay analyzers for mid- and high-volume laboratories •
Detection or quantitation for hemolysis, icterus, lipemia, clots detection for clots; hemolysis, icterus, lipemia not available Chemistry and immunoassay analyzers for point-of-care and low-volume
Dilutes patient samples onboard/Susceptibility to carryover yes (can be programmed to perform dilutions prior to laboratories • Coagulation analyzers
analysis)/—
Automatic rerun capability no • Hematology analyzers
Sample volume can be diluted to rerun out-of-linear-range high results no • Next-generation sequencing systems
Sample volume can be concentrated to rerun out-of-linear-range no
low results
• Urinalysis instrumentation 46 CAP TODAY | JUNE 2024 CHEMISTRY and IMMUNOASSAY ANALYZERS CHEMIST
Part 1 of 6 Abbott Point of Care Awareness Technology Awareness Technology Part 2 of 6 Beckman Coulter
Jeff Abney [Link]@[Link] Rafael Castillo rcastillo@[Link] Rafael Castillo rcastillo@[Link] Doug Lee dylee@beck
for POINT–OF–CARE and for POINT–OF–CARE and Brea, CA

Analyzer requires dedicated water supply no

Princeton, NJ Palm City, FL Palm City, FL
LOW–VOLUME LABORATORIES 609-454-9000 [Link]/us/en/home 772-283-6540 [Link] 772-283-6540 [Link] LOW–VOLUME LABORATORIES 800-526-3821 [Link]
Name of instrument i-STAT 1 analyzer ChemWell 2910 ChemWell-T 4620 Name of instrument Access 2

SOFTWARE SYSTEMS
Type of instrument combination chemistry/immunoassay combination chemistry/immunoassay chemistry Type of instrument immunoassay
Operational type/Model type discrete/handheld batch, random access, discrete/benchtop batch, random access, discrete/benchtop Operational type/Model type continuous random acce

Autocalibration/Multipoint calibration supported no (calibrants are not stored onboard)/yes (recommended

List price/First year sold in U.S. —/2000 $29,000/1998 $14,000/2014
Targeted hospital bed size/Targeted test volume all/— 200/daily: 200–500; monthly: 200–400 200/— List price/First year sold in U.S. —/2001
Company manufactures instrument yes (also sold by McKesson, Henry Schein, Medline) yes (also sold by GMI, Monobind, ASI, others) yes Targeted hospital bed size/Targeted test volume —/annual: < 40,000
Other models in this family of analyzers i-STAT Alinity ChemWell Fusion, ChemWell-T, ChemWell 2902 ChemWell Fusion, ChemWell 2910, ChemWell 2902
No. of units in clinical use in U.S./Outside U.S. (countries) > 30,000/> 10,000 (Europe, Latin America, Africa, Middle 500/7,000 (worldwide) 200/4,500 (worldwide) Company manufactures instrument yes (also sold by McKess
East, Asia Pacific) Fisher Scientific)

avg. frequency: per run) • Anatomic pathology computer

Dimensions (H × W × D)/Instrument footprint 9.25 × 3 × 2.85 in./< 1 sq. ft. 18.625 × 36.25 × 21.5 in./< 7.905 sq. ft. 20.87 × 19.69 × 18.5 in./2.853 sq. ft. Other models in this family of analyzers Unicel DxI 600, Unicel Dx
Weight empty/Weight fully loaded < 2 lbs./< 2 lbs. 77 lbs./78 lbs. 37 lbs./— No. of units in clinical use in U.S./Outside U.S. (countries) —
No. of different measured assays onboard simultaneously — 15 (12 can be run and calibrated at one time) 15 (12 can be run and calibrated at one time) Dimensions (H × W × D)/Instrument footprint 19.5 × 39 × 24 in./6.5 s
No. of user-definable (open chemistry) channels — — — Weight empty/Weight fully loaded 200 lbs./—
Test throughput per hour/Assay run time —/2–10 min. 200 (27 tests in throughput)/6–120 min. 100/— No. of different measured assays onboard simultaneously 24 (24 can be run and ca

Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/per run

Chemistry: No. of user-definable (open chemistry) channels —
No. of direct ion-selective electrode channels up to 26 — — Test throughput per hour/Assay run time up to 100/13–55 min.
Detection methods potentiometry, amperometry, conductometry photometry photometry Chemistry:

systems • Billing/accounts
Stat time until completion/specimen throughput for: No. of direct ion-selective electrode channels —
• Ion-selective electrode 2 min./20–25 — — Detection methods —
• Basic metabolic panel 2 min./20–25 assay dependent assay dependent Stat time until completion/specimen throughput for:

drugs of abuse/general chemistries/immunoassays

• Complete metabolic panel — assay dependent assay dependent • Ion-selective electrode —
Typical time delay from ordering stat test until aspiration of sample none assay dependent assay dependent • Basic metabolic panel —
Immunoassay: • Complete metabolic panel —
Fully automated microplate immunoassay system yes (up to 26 tests per unit) yes (27–44 tests per unit; 96 wells per microplate) — Typical time delay from ordering stat test until aspiration of sample —
Methodologies supported potentiometry, amperometry, conductometry enzyme immunoassay, colorimetric analysis — Immunoassay:

receivable/RCM systems
Separation methodologies none necessary none necessary, coated microwell —

Automatic programmable start/Automatic programmable shutdown no/no

Fully automated microplate immunoassay system no
Stat time until completion of a ß-hCG test 10 min. assay dependent — Methodologies supported chemiluminescence
• Typical time delay from test order to aspiration of sample none assay dependent — Separation methodologies magnetic particle
Stat time until completion of a cTn test 10 min. assay dependent — Stat time until completion of a ß-hCG test 15 min.
42 CAP TODAY | MARCH 2020 • Typical time delay fromBEDSIDE
test order to aspiration ofGLUCOSE
sample none TESTING SYSTEMSassay dependent — • Typical time delay from test order to aspiration of sample 36 sec.
Approximate No. of tests per reagent set/Reagent type —/self-contained single use assay dependent/open reagent system assay dependent/open reagent system Stat time until completion of a cTn test 17 min.
Part 1 of 3 Abbottonboard/Reagents
Diabetes Care ready to use Abbott Diabetes Care Arkrayon optional cooling accessory)/yes Part 2 of 3 • Typical timeArkray 36 sec. Nova Biomedica

Onboard real-time QC/Onboard software capability to review QC yes/yes

Reagents refrigerated no/— yes (12°–15°C –15°C)/yes
–15
yes (8°–15°C)/yes delay from test order to aspiration of sample
Alameda, CAinventory
Reagent lot tracking/Reagent no/no Alameda, CA yes/yes Edina, MN yes/yes Edina, MN Nova Sales inf
Approximate 800-818-8877
No. of tests per reagent set/Reagent type 50 per pack or 100MA
per k

• Laboratory information
See [Link]/bedside-glucose for an 877-643-2098
Reagent form/Reagents barcoded 877-643-2098
dry chemistry, 800-818-8877
liquid chemistry (closed reagent system)/yes liquid chemistry (open reagent system)/yes See [Link]/bedside-glucose
liquid chemistry (open reagent system)/yes for an Waltham,
interactive product comparison or PDF of guide Separate [Link]/fspp
pack for each specimen/for each test run no/no no/yes [Link] no/yes interactive product comparison or PDF of guide [Link] 781-894-0800 o
Reagents refrigerated onboard/Reagents ready to use yes (2°–8°C)/yes
Walkaway capability/Walkaway duration yes/2–10 min. or 1 specimen or up to 13 tests yes/480 min. yes/120 min. Reagent lot tracking/Reagent inventory yes/yes StatStrip Xpress2
Name of instrument/First year sold Freestyle Precision Pro Blood Glucose and Precision Xceed Pro Blood Glucose and Assure Platinum/2010 Name of instrument/First year sold Assure Prism multi/2015
Design of sample-handling system System/2013
β-Ketone Monitoring — β-Ketone Monitoring System/2008 rack (custom reagent and sample racks) rack (custom reagent and sample racks) Reagent form/Reagents barcoded liquid chemistry (closed r

Supports multiple QC lot numbers per analyte no

Uses washable cuvettes/Uses disposable cuvettes no/no yes/yes yes/yes (can store up to 40Professional
cuvettes) or home use professional
Separate reagent pack for each specimen/for each test run no/no professional
Professional or home use Min.–max. sampleprofessional
volume that can be aspirated at one time 17–95 µL professional 2–250 µLprofessional 2–388 µL Total units sold in U.S./Total units sold outside U.S. —
Walkaway capability/Walkaway duration yes/180— min. or 60 spec
Total units sold in U.S./Total units sold outside U.S. —
Min. reaction volume/Min. specimen volume/Min. dead volume — — — µL/100 µL
100 µL/100 240 µL/2 µL/40 µL No. of contracts for product signed in 2019 —
Design of sample-handling system rack —
No. of contracts for product signed in 2019 — sample cup
Dedicated pediatric no — no — no Dimensions (H × W × D)/Weight Uses washable3.66 × 2.2 × 0.83disposable
cuvettes/Uses in./2.1 [Link] 3.9 store
no/yes (can × 2.4up
× 0.9
to 2

systems
Dimensions (H × W × D)/Weight length: 7.85 in. ±.08; width: 2.93 in. ±.08;
Primary tube sampling no 7.7 × 2.96 × 1.2 in./9 oz. yes 4.5 × 2.5 × 1.2 in./2.8 oz. yes Analytical method or technology or enzyme system used Min.–max. sample
glucose oxidase
volume that can be aspirated at one time 5–200 µLelectrochemical
Accommodates mostthickness:
standard1.92tube
in. ±.08/10.58
sizes/Acceptsoz. nonstandard
±.51 no/no yes/yes (13 mm) yes/yes (12 × 75 mm, 13 ×No.100 mm)
of disposable reagent system units per basic package Min. reaction 50 volume/Min.
or 100 specimen volume/Min. dead volume varies by50assay/varies by

Waste management automated collection onboard instrument

Analytical method or technology or enzyme system used tube sizes glucose-specific GDH-NAD enzyme and low applied glucose-specific GDH-NAD enzyme and low applied glucose oxidase test strips pe
Disposable units shelf life Dedicated pediatric
18 months sample cup yes (dead24volume:
months80 μL
from
voltage to
Pierces caps on primary tubes minimize interference; β-hydroxybutyrate,
no the voltage to minimize interference; β-hydroxybutyrate,
nothe no Primary tube sampling yes
Reagent unit storage requirements 34°–86°F room temperatur
Protects against predominant
probe collision blood ketone associated with DKA no predominant blood ketone associated with DKA yes yes Accommodates most standard tube sizes/Accepts nonstandard yes/no
No. of disposable reagent system units per basic packageDetects clots/liquid level/short
glucose: sample wrapped strips;
100 individually yes/yes/yesglucose: 100 individually wrapped strips; no/yes/yes50 or 100 no/yes/yes Digital readout character size/Keypad input capability tube sizes — variable (defined
Detection or quantitation
ketone: 50for individually
hemolysis, icterus,
wrapped lipemia,
strips clots detection forketone:
hemolysis, icterus, lipemia,
50 individually clotsstrips
wrapped assay dependent assay dependent Pierces caps on primary tubes no selection
Disposable units shelf life Dilutes patient samples
18 monthsonboard/Susceptibility to carryover no/— 18 months yes (can be
18 programmed
months to perform dilutions prior to yes (can be programmed toHowperform
resultsdilutions prior to
are displayed Protects against
trueprobe
valuescollision no plasma equivale
Reagent unit storage requirements 39°–86°F (4°–30°C) 39°–86°F (4°–30°C) analysis)/no carryover
39°–86°F analysis)/no carryover Specimen types Detects clots/liquid level/short sample
whole blood yes/yes/yes
whole blood
Automatic rerun capability no yes yes Sampling techniques Detection or quantitation
drop for hemolysis, icterus, lipemia, clots detectiondrop,
for clots; hemo
capillary tr

Sample barcode-reading capability/Autodiscrimination yes (Interleaved 2 of 5, UPC, Codabar, Code 39, Code 128, EAN,
Digital readout character size/Keypad input capability Sample volume can be diluted to rerun out-of-linear-range
variable/alphanumeric keypad high results no variable/alphanumeric keypad yes — yes Minimum specimen volume required Dilutes patient0.5samples
μL onboard/Susceptibility to carryover yes (can 1.2
be programmed
μL t
How results are displayed Sample volume can be concentrated
plasma equivalent to rerun out-of-linear-range
glucose values no plasma equivalent glucose values yes true values yes Suitable for samples from well neonates/Sick neonates no/no yes/yes
Specimen types low results glucose and ketone: fresh capillary, venous, arterial, or glucose: fresh capillary, venous, arterial, or neonatal whole whole blood Time from sample introduction to result availability Automatic rerun capability
5 seconds no 6 seconds
Analyzer requiresneonatal
dedicated whole
waterblood
supply no blood; ketone: fresh capillary and venous whole bloodno no Batteries used/No. used/Average life of one set of batteriesSample volume3vcan be diluted
lithium to rerun out-of-linear-range
(disposable, high results
type CR2032)/2/1,000 tests yes AAA/2/minimum
Sampling techniques top-fill or end-fill
Autocalibration/Multipoint sample
calibration application
supported top-fill
yes (calibrants or end-fill
are not stored sample application
onboard)/yes (recommended drop can be stored onboard)/yes (recommended
no (calibrants no (calibrants can be stored onboard)/yes (recommended Sample volume can be concentrated to rerun out-of-linear-range no
Minimum specimen volume required glucose: 0.6 μL; ketone: 1.5 μL glucose:
avg. frequency: each 0.6
test)μL; ketone: 1.5 μL 0.5 μL test dependent)
avg. frequency: Average expected life of device
avg. frequency: test dependent) low results 3 years >5 years

EAN-128)/no
Suitable for samples from well neonates/Sick neonatesTypical calibration yes/yes
frequency for ISE/therapeutic drugs/ —/—/—/each yes/yes
test/each test — no/no — Device warranty 3 years
Analyzer requires dedicated water supply no 2 years (optional
Time from sample introduction to result availability glucose: 5chemistries/immunoassays
drugs of abuse/general seconds; ketone: 10 seconds glucose: 20 seconds; ketone: 10 seconds 7 seconds Service options/Loaners provided —/yes
Autocalibration/Multipoint calibration supported meterare
no (calibrants replaceme
not sto
Batteries used/No. used/Average life of one set of batteries AA alkaline,
Automatic programmable lithium, nickel
start/Automatic cadmium, shutdown
programmable or NiMH yes/yes AA alkaline or NiMH rechargeable/depends on type/ no/no AAA/2/5,000 tests with 4 tests per day no/no avg. frequency: 28 days)
Onboard real-timerechargeable/depends on type/depends
QC/Onboard software capability to reviewonQCuse yes/yes depends on use yes/yes yes/yes User list or user group no no
Typical calibration frequency for ISE/therapeutic drugs/ —/—/—/—/28 days
Average expected life of device Supports multiple—QC lot numbers per analyte yes — yes 5 years yes Toll-free No. for customer questions/Hours of operation 800-818-8877/24 hours, 7 days 800-458-5813/2
drugs of abuse/general chemistries/immunoassays

Lab can control analyzer from remote computer no

Device warranty Waste management 1 year or contract term manually by1user
year or contract term manually 5byyears
user, automated collection onboard instrument, direct to drain Training and certification program/No. of training days provided yes/one on site yes/defined durin
Automatic programmable start/Automatic programmable shutdown no (< 5 min. start-up tim
Service options/Loaners provided replacement/no replacement/no —/yes
direct to drain Onboard real-time QC/Onboard software capability to review QC no/yes CLIA requiremen
Internal QC recommended or required control solution testing
User list or user group Sample barcode-reading
— capability/Autodiscrimination yes (Interleaved
— 2 of 5, Codabar, Code 39, Code 128, EAN-8, yes (Codeno39, Code 129)/no yes (Code 39, Code 129)/no Supports multiple QC lot numbers per analyte yes policy
Toll-free No. for customer questions/Hours of operation 877-529-7185/24 hours, 7 days, all year EAN-13)/—877-529-7185/24 hours, 7 days, all year 800-818-8877/24 hours, 7 days Waste management automated collection onb
Accuracy slope=1.0, y-inter.= -7.39 mg/dL, r=0.99 >97% versus ID
Lab can control analyzer from remote computerplan yes yes yes Sample barcode-reading capability/Autodiscrimination yes (Interleaved
Training and certification program/No. of training days provided yes/based on implementation yes/based on implementation plan yes/one on site method 2 of 5, C

Instrument can diagnose its own malfunctions no (operator intervention required to order parts)
Instrument can diagnose its own malfunctions yes (operator intervention required to order parts) yes (operator intervention required to order parts) yes (operator intervention required to order parts)
Internal QC recommended or required as defined • Compared with what reference method or device YSI model 2300 glucose analyzer tested to CLSI PO
System malfunctions can bebydiagnosed
facility orvia
institutional policy
remote monitoring yes as defined by facility or institutional policy yes control solution testing yes Lab can control analyzer from remote computer yes
UPS backup power supply no no no Precision Instrument can diagnose
results its ownconcentration
for glucose malfunctions≥75 mg/dL: 100% within yes (operator
withinintervention
run=1.9–
Accuracy Data-management capillary blood glucose
capability/LIS or EHRresults:
systems100% within ±15 mg/dL
interfaced capillary blood glucose results: 97% within ±15 mg/dL
optional add-on/— onboard/—slope=1.0, y-inter.= -2.33, r=0.99 onboard/— System malfunctions
±20%; 98% can be diagnosed
within ±15%; via80%remote
withinmonitoring yes
±10%; 42% within day to day=3.4–
or ±15%; 95.1% within ±10 mg/dL or ±10% or ±20% UPS backup power supply for glucose concentration <75 mg/dL: 100%
±5%; results no
• Compared with what reference method or device LIS interface provided/Bidirectional
YSI glucose analyzer interface capability YSIcost)/no
yes (additional glucose analyzer yes/yes YSI model 2300 glucose analyzer yes/yes Data-management
within capability/LIS
±15%; 100% or EHR ±10%;
within systems100%interfaced
within ±5%onboard/Cerner, Antrim, CC

System malfunctions can be diagnosed via remote monitoring no

• Compared with what reference method or device YSI model 2300 glucose analyzer ADAC, Dynamic
— Healthcar
Precision repeatability: pooled whole blood SD 2.8 mg/dL at con- repeatability: CV ranges from 3.0% to 4.9% across AMR results for glucose concentration ≥75 mg/dL: 100%
Modem servicing provided/Service engineer on-site response time —/— (product replacement within 24 hrs.) no/72 hrs. no/72 hrs. LIS interface provided/Bidirectional interface capability yes (included in instrume
centrations <75 mg/dL and <3.6% CV for concentrations within ±20%; 96% within ±15%; 79% within ±10%; 53% Linear range 20–600 mg/dL
Mean time between ≥75 failures
mg/dL; intermediate precision: pooled whole — (displays error codes for troubleshooting)
blood 1–2 service visits
within per results
±5%; year (displays errorconcentration
for glucose codes for <75 mg/dL: 1–2 service visits per year (displays error codes for Modem servicing provided/Service engineer on-site response time yes/< 2410–600 hrs. mg/dL (
troubleshooting) troubleshooting) Suggested dynamic or measurement range 20–600 mg/dL 10–600 mg/dL (
SD 2.8 mg/dL at concentrations <75 mg/dL and <5.0% 100% within ±15 mg/dL; 100% within ±10 mg/dL; 88% Mean time between
Contraindications yes (perfailures
labeling) 1.4 downnone service calls p
Average scheduled for maintenance ≥75bymg/dL
concentrationstime lab personnel — daily: 15 min.
within ±5 mg/dL daily: 15 min. troubleshooting)
Known interferences yes (per labeling) none
• Compared with what reference method or device Maintenance records — kept onboard for user/vendor — no/no YSI model 2300 glucose analyzer no/no Average scheduled maintenance time by lab personnel daily: 7 min.;
none,weekly: 12

UPS backup power supply yes

— High-altitude interference none, up to 10,000 feet up to 15,0
Maintenance training demonstration module onboard — no no Maintenanceyes, records kept onboard for user/vendor no/no no
Linear range Restrictions based on hematocrit hematocrit range: 20–60%
Training included glucose: 20–500 mg/dL;
with purchase/Avg. ketone:
time for 0–8 mmol/L
basic user training —/4 hrs. (atglucose:
customer 20–500
site) mg/dL; ketone: 0–8 mmol/L 20–600
yes (1 training mg/dL
slot)/4 days (at customer or vendor site) yes (1 training slot)/2 days (at customer or vendor site) Maintenancebattery,
trainingtest
demonstration modulesystem,
onboardand sample errors
yes
Suggested dynamic or measurement range glucose: 20–500 charge
mg/dL;forketone: 0–8 mmol/L glucose: 20–500 mg/dL; ketone: 0–8 mmol/L 20–600 or mg/dL Electronic and optical function checks strip, temperature, electronic check
Advanced operator training/Extra follow-up yes (at customer site)/no yes (at customer vendor site)/yes yes (at customer or vendor site)/yes Training included with purchase/Avg. time for basic user training yes (2 training slots)/2 d
Contraindications yes (per labeling) yes (per labeling) yes (per labeling) out-of-range Hct
or advanced training Advanced operator training/Extra charge
Known interferences yes (peroflabeling) yes (per labeling) yesfrom date of shipment)/contract dependent Sample quantity checks fill-trigger electrode on eachfor
testfollow-up yes (at vendor
strip designed to start site)/—
RapidFill samplin
Warranty provided/Cost annual service contract (24 h/7 d) yes (1 year)/— yes (1 year yes (1 year from date of shipment)/contract dependent or advancedthetraining
test when sufficient sample is detected dosing
High-altitude interference none (tested up to 7,200 feet) none (tested up to 7,200 feet) none, up to 10,000 feet

Data-management capability/LIS or EHR systems interfaced onboard/—

Distinguishing features (suppliedrange:
by company) • handheld yes,
portable analyzer; unit use system can perform • verticalyes,
platehematocrit
reading forrange:
biochemistries • compact low-cost analyzer Whenthatauto
saveslockonorreagent
shutdown
use;occurs
open Warranty provided/Cost of annual
user flags control service
solution contract
tests when (24 h/7 d)
conducted yes (1 year)/—
—
Restrictions based on hematocrit yes, hematocrit 15–65% hematocrit range: 20–70% 30–55%
Electronic and optical function checks battery, barcode scanner, database, and temperaturechemistry,battery,
blood gas, cardiac
barcode marker,database,
scanner, and coagulation tests • 2-in-1 utility
and temperature battery,with
testthestrip,
ability to run in ELISA
temperature, modemeasurement,
EEPROM, or system; remote access Distinguishing features (supplied by company) • offers the robustness of
checks performed during power-up • CLIA-waived tests,performed
checks including glucose and creatinine
during power-up biochemistry modetransmission, and thermistor errors
self-check, User can define QC lockout intervals/QC lockout can be circumvented no/no
• flexibility of hardware/software no/—
analyzer in convenient s
Sample quantity checks test strip contains fill-trigger electrode designed to•start
uses 2–3 test
dropsstrip
of whole blood
contains or plasma
fill-trigger • low-costfill-trigger
electrode designed to start analyzer electrode
that savesononeachreagent
test use;
stripopen to start• software included (free) Information for which device supports barcode scanning
system;
designed no barcode scanner no barcode
• standardization scan
of result
the test when sufficient sample is detected the test when sufficient sample is detected remote access; software included (free)
the test when sufficient sample is detected Method of analyst ID/ID required — none/—
segments
When auto lock or shutdown occurs configurable lockout for operator certification, strip lot, configurable lockout for operator certification, strip lot, — Internal memory size 500 tests • reliable400 tests total
benchtop (F
system

LIS interface provided/Bidirectional interface capability —/yes (host query)

upload, Maximum No. of patient results stored 500 tests results400 tests
as the coretotal
lab (F
Note: a dash in lieu of an and QC requirements
answer means company upload, and QC requirements Note: a dash in lieu of an answer means company
User can define QC lockout intervals/QC lockout can be circumvented yes/no or question is not applicable
did not answer question yes/no yes/yes did not answer question or question is not applicable
36 CAP TODAY | MARCH 2020 Information for which device supports barcode scanning operator ID, patient ID, strip lot, QC, comment code, and operator ID, patient ID, strip lot, QC, comment code, and — Meter connections for information transfer — —
free textbyfield How meters are connected to external system to upload results — —
All information is supplied thedata free text
companies listed. The tabulation does not represent anfield data
endorsement by the CAP. Information contained in transmission to external systemAll information — is supplied by the companies listed. The tabulation does not — represent an end

POC panel talks diabetes care, data management, CGM

Method of analyst ID/ID required scan or manual entry/required scan or manual entry/required —
Internal memory size patient test results: 2,500; control test results: 1,000; patient test results: 2,500; control test results: 1,000; 500 tests

Modem servicing provided/Service engineer on-site response time —/24 hrs.

patient IDs: 6,000; operator IDs: 6,000; test strip lots: 36 patient IDs: 6,000; operator IDs: 6,000; test strip lots: 36 Hardware and software for data-management system — none
(18 glucose, 18 ketone) (18 glucose, 18 ketone)
Maximum No. of patient results stored same as internal memory size same as internal memory size 500 tests
Data management, diabetes care, the demand for continuous glucose monitoring, and Arkray: Arkray’s focus has been long- the only way to ensure that everything JUNE 2024 page 46
Information downloaded from DMS to meter — —
device cleansing were up for discussion when CAP TODAY publisher Bob McGonnagle term care from a point-of-care per- is accurate Meterisconnections
to haveforthe results
information real-
transfer data-management system, which connects to LIS/HIS data-management system, which connects to LIS/HIS —
led a point-of-care glucose testing roundtable in January. Joining him were Todd Cullen spective and blood glucose monitor- How meters areinto
time downloaded connected
thetolaboratory
external system to upload results real-time wireless data transfer via meter or through data transfer via docking station connected to ethernet or —
LISs/HISs to which system is connected (live installs) using:
docking station connected to ethernet wireless workstation
of Arkray, Corinne Fantz, PhD, DABCC, of Roche, and Susan Fuhrman, MD, of ing. Our challenge over the many information system.
Information If you
contained look attothe
in transmission external system device unique identifier, operator ID, patient ID, reagent device unique identifier, operator ID, patient ID, reagent —
• Screen animation/Screen scraping — —
• Standard HL7 interface — —

Mean time between failures — (displays error codes for troubleshooting)

OhioHealth Laboratory Services. Here is what they said. years I’ve been with Arkray, and it different ways diabetes is handled in and QC lot numbers, test results, comment codes, and and QC lot numbers, test results, comment codes, and
• Proprietary protocol interface — —
CAP TODAY’s product guide to bedside glucose testing systems begins on page 42. free text entry free text entry
continues to this day, is access to high- medical centers and in hospital com- Use 3rd-party interfacing tool or engine for LIS or HIS interfaces — —
Hardware and software for data-management system compatible with data-management systems from Abbott compatible with data-management systems from Abbott —
Todd, as we begin 2020, what’s topmost in and opportunities, and in terms of what quality, accurate diagnostic products, puter systems, most of the computer (Alere), Siemens, and Telcor (Alere), Siemens, and Telcor LOINC can be used to identify tests when communicating with LIS — —
your mind as you look at the point-of-care
KRgen_2thirdsIslandCapToday_2002_x1a.pdf 1 2/24/20 you’re
1:03 hearing
PM from your customers? blood glucose monitors at the bedside, systemsInformation
have thesedownloaded diabetic
from DMS toflow
meter operator list, patient list, strip lot list, adjusted QC ranges, operator list, patient list, strip lot list, adjusted QC ranges, —
Distinguishing features (supplied by company) • optimized readout display: large, thick numbers are • only meter FDA

Average scheduled maintenance time by lab personnel daily: 10 min.; weekly: 30 min.; monthly: none
testing field and at Arkray’s challenges Todd Cullen, director of marketing, but cost has been a significant chal- sheets, but the algorithms for the labo- and meter configuration settings and meter configuration settings
intended to improve readability including capil
LISs/HISs to which system is connected (live installs) using:
lenge for long-term care facilities, ratory information systems scraping
• Screen animation/Screen are differ- — — — • compact design: small, lightweight design provides • measures and
better portability oxygen, acetam
where almost 30 percent of the popu- ent. In some instances
• Standard we’ve found
HL7 interface — — —
other electroch
• Proprietary protocol interface — — — • other features: auto coding, LCD backlit display, and
lation has diabetes. It’s the cost of that people were hand-entering results
Use 3rd-party interfacing tool or engine for LIS or HIS interfaces yes, via Abbott (Alere), Siemens, or Telcor yes, via Abbott (Alere), Siemens, or Telcor — test strip ejector maltose, galac
entry

Maintenance records kept onboard for user/vendor some records/some records

LOINCinto those
can be used worksheets
to identify tests when communicating with LIS yes yes —
E T

• only meter CLI

C

prior to the(supplied
resultsby cross-
ID U

Bedside glucose testing systems, pages 42–44 Distinguishing departments, o

U D

features company) • individually foil-wrapped test strips support a no-touch • individually foil-wrapped test strips support a no-touch • hypoglycemic alert: audio alert is designed to improve
G O
R

ing over to the lab system, procedure and vial-free solution, which assists in procedure and vial-free solution, which assists in resident safety
P

complying with CDC and CLSI recommendations for complying with CDC and CLSI recommendations for • qcProGuard: control solution test notifications provide
so we would end up with bedside testing supplies bedside testing supplies additional quality control; ProGrip: rubberized case
managing their residents’ diabetes. two results in the same place or two

Maintenance training demonstration module onboard no

• 1D/2D barcode reader; real-time dual band wireless • TrueID technology with active patient ID confirmation, design for secure handling
The expensive control solution testing, results in different places that weren’t data transmission; TrueID technology with active patient which assists in complying with the Joint Commission’s • other features: auto coding, LCD backlit display, and
ID confirmation, which assists in complying with the NPSG.01.01.01 test strip ejector
safety lancets, and ancillary products exactly the same and it was problem- Joint Commission’s NPSG.01.01.01 • replaceable strip port module
make it challenging for them to man- atic. GettingNote: aour
dasharms
in lieu ofaround
an answerthat
meansand
company did
• hematocrit compensation algorithm; replaceable strip
Note: a dash in lieu of an answer means company did
port module
age their residents’ diabetes outside of making sure all of
not answer ourorresults
question are
question is not elec-
applicable not answer question or question is not applicable

Training included with purchase/Avg. time for basic user training yes/3 hrs. (at customer site)
standard, inexpensive blood glucose tronically transmitted real time has
All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP.
meters that they can buy from certain been key.
distributors. So one of the challenges I spoke at the CAP meeting in Sep-
we’ve taken on is trying to provide tember last year on this subject, and

Advanced operator training/Extra charge for follow-up yes (at customer or vendor site)/—
0320_42-44_BedsideGlucose-[Link] 42 3/6/20 2:44 PM
high-quality products they can trust several participants questioned me MARCH 2020 page 42
from an accuracy perspective, with about our laboratory information sys-
ease of use, but that won’t cost them tem—how did we do it and how did
significant money out of their pocket, we make sure it was real time?—be-

or advanced training
because blood glucose monitoring in cause it is a pain point for everyone. I
long-term care is not reimbursed. would say the biggest advocate for
One of the big challenges has been making sure this makes sense is a
a request from our customers for con- good diabetic care clinical team, be-

Coming
tinuous blood glucose monitoring and cause they will want this fixed.

Warranty provided/Cost of annual service contract (24 h/7 d) yes/—

questions about how manufacturers
like us and others are addressing that Can you share with us what your solu-
for them. As they see it out in the con- tion was? Did you use a middleware
sumer market, how can we translate vendor? Did you use a special product
that into the point-of-care market? In like Alere’s RALS or one of the others
a hospital setting they do have limited that are out there?

Distinguishing features (supplied by company) • four independent washable probes with two dual probes for
in October:
access to that, but it hasn’t been an Dr. Fuhrman (OhioHealth): We did
option in long-term care. So the big- use the RALS system, but we had had
gest challenge that Arkray and other time delays built in. RALS is meant to
manufacturers will see over the next be handled for point of care. The main

individual IFA well washing and mounting media dispensing

year and over several years is how we way it happens is that the instrument
address that continuous glucose moni- does the testing and the result goes
toring request from our customers. It over. If you want it to hold, you can
seems to be the next step for them. have it held for one of your point-of-

• reagent integrity and positive patient identification

care coordinators to send it to the LIS
Dr. Fuhrman, we know that diabetes is or you can set a time limit for a hold.

Hematology
almost epidemic, and Todd has given us But you can’t have your users release
a good idea about the challenges in long- it like they would for a regular lab test.
term care facilities and the percentage of So we had a hold in place and we

managed through reagent and patient barcode scanning the population there that has diabetes.
What are the diabetes and glucose-test-
ing–related challenges and the opportu-
nities at OhioHealth?
took the hold off because we figured
that the risk of having a result trans-
mitted that somebody then had to
repeat was so much less than the risk

• 240 sample capacity open IFA/ELISA system with 70

Susan Fuhrman, MD, system di- of the wrong number being put in. We
rector of OhioHealth Laboratory Ser- originally had the hold because we
vices and president, CORPath LLC: were worried that people would test
We have hundreds and hundreds of again and then there would be two

analyzers
reagent and control positions allow for maximum walkaway
glucose meters and thousands of us- and three results, and that turns out to
ers, and keeping all of that orga- have been a small problem compared
nized—because of the sheer volume— with the large problem that we would
is difficult. The other thing we’ve have when we didn’t have immediate

time
struggled with and we finally have transmission, because those nurses are
down is data management. With thou- dosing the insulin right then and there,
sands of blood glucose results a day, and if they don’t —continued on 38

0320_36-40_POCT [Link] 36
MARCH 2020 page 36 3/3/20 2:24 PM

Note: a dash in lieu of an answer means company

did not answer question or question is not applicable

All information is supplied by the companies listed. The tabulation does not represent an endorsement by the CAP. [Link]