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ELITech Reagents Assay Values Guide

This document provides control values for various biochemical analytes to be used with ELITech reagent kits on Selectra/Flexor analyzers. It lists the code, reagent name, method, traceability, units, target value, and range for analytes such as albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma-glutamyl transferase, glucose, and others. The values are defined for use specifically with ELITech reagents.
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0% found this document useful (0 votes)
2K views2 pages

ELITech Reagents Assay Values Guide

This document provides control values for various biochemical analytes to be used with ELITech reagent kits on Selectra/Flexor analyzers. It lists the code, reagent name, method, traceability, units, target value, and range for analytes such as albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, bilirubin, calcium, chloride, cholesterol, creatinine, gamma-glutamyl transferase, glucose, and others. The values are defined for use specifically with ELITech reagents.
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • ELITROL II Specifications and Details
  • Extended ELITROL II Product Data

ELITROL II

: CONT-0160/1160

: 02-2100 : 2021-11

(OLWURO,, 
& )9&217
 

FOR SELECTRA / FLEXOR ANALYSERS


CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
ALBU-0XXX ALBUMIN Bromocresol green ERM-DA 470k / IFCC g/dL 4.99 4.09 5.89
g/L 49.9 40.9 58.9
) ALBU-0XXX ALBUMIN Bromocresol green ERM-DA 470k / IFCC g/dL 4.78 3.92 5.64
IMPROVED APPLICATION Assay Code 101 g/L 47.8 39.2 56.4

PASL-0XXX ALP (DEA) SL DGKC Manual measurement IU/L 37°C 277 227 327

IFCC formulation (Schumann,2011),


ALPI-0XXX ALP IFCC IFCC IU/L 37°C 203 166 240
manual measurement
ALSL-0XXX ALT / GPT 4+1 SL IFCC formulation (Schumann, 2002),
IFCC without pyridoxal-phosphate IU/L 37°C 137.2 112.5 161.9
manual measurement
CNP-G3 substrate IFCC formulation (Schumann, 2006),
AMSL-0XXX AMYLASE SL IU/L 37°C 237 194 280
manual measurement
ASSL-0XXX AST / GOT 4+1 SL IFCC formulation (Schumann, 2002),
IFCC without pyridoxal-phosphate IU/L 37°C 126.6 103.8 149.4
manual measurement
BITO-0XXX TOTAL BILIRUBIN 4+1 Malloy-Evelyn modified NIST SRM 916a mg/dL 6.75 5.53 7.97
BITD-0XXX IMPROVED PRODUCT Assay Code 225 μmoL/L 115.5 94.7 136.3
BIDI-0XXX DIRECT BILIRUBIN 4+1 Malloy-Evelyn modified NIST SRM 916a mg/dL 5.45 4.14 6.76
BITD-0XXX IMPROVED PRODUCT Assay Code 205 μmoL/L 93.2 70.8 115.6
CALA-0XXX CALCIUM ARSENAZO Arsenazo )NIST SRM 956d mg/dL 11.71 10.31 13.11
mmoL/L 2.92 2.57 3.27
CHLO-0XXX CHLORIDE Colorimetric, end point NIST SRM 909c mEq/L 115.2 103.7 126.7
mmoL/L 115.2 103.7 126.7
3918-006 CHLORIDE I.S.E Indirect Potentiometry NIST SRM 918b / NIST SRM 919b mEq/L 105.4 94.9 115.9
mmol/L 105.4 94.9 115.9
CHSL-0XXX CHOLESTEROL SL mg/dL 183 156 210
Enzymatic colorimetric (CHOD-PAP) ID-GC-MS
mmol/L 4.73 4.02 5.44
HDLL-0XXX CHOLESTEROL HDL SL 2G mg/dL 49 42 56
Colorimetric, end point CDC method
mmol/L 1.26 1.07 1.45
LDLL-0XXX CHOLESTEROL LDL SL 2G mg/dL 96 82 110
Colorimetric, end point CDC method
mmol/L 2.49 2.12 2.86
CKSL-0XXX CK NAC SL IFCC formulation (Schumann, 2002),
IFCC IU/L 37°C 305 250 360
manual measurement
CREATININE PAP SL Enzymatic colorimetric (PAP) ID-MS mg/dL 3.75 3.07 4.43
CRSL-0XXX
μmol/L 332 272 392
CRCO-0XXX CREATININE JAFFE mg/dL 3.02 2.48 3.56
Jaffe without deproteinization ID-MS
μmol/L 267 219 315
IFCC formulation (Schumann, 2002),
GISL-0XXX GAMMA GT PLUS SL IFCC IU/L 37°C 213.2 174.8 251.6
manual measurement
GPSL-0XXX GLUCOSE PAP SL Enzymatic colorimetric (GOD-PAP) ID-MS mg/dL 222.4 189.0 255.8
mmol/L 12.34 10.49 14.19
GHSL-0XXX GLUCOSE HK SL Hexokinase ID-MS mg/dL 228.4 194.1 262.7
mmol/L 12.68 10.78 14.58
The values are defined with ELITech reagents

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ELITROL II ELITROL II
: CONT-0160/1160 : CONT-0160/1160

: 02-2100 : 2021-11 : 02-2100 : 2021-11

FOR SELECTRA / FLEXOR ANALYSERS FOR ENVOY ANALYSERS


CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
CODE REAGENT NAME METHOD TRACEABILITY UNITS TARGET RANGE
ALBU-0850 ALBUMIN ENVOY Bromocresol green ERM-DA 470k / IFCC g/dL 4.78 3.92 5.64
FEFR-0XXX IRON FERROZINE NIST SRM 937 μg/dL 277 227 327 g/L 47.8 39.2 56.4
Ferrozine without deproteinization
μmol/L 49.6 40.7 58.5 IFCC formulation (Schumann,2011),
PIVD-0850 ALP ENVOY IFCC (AMP Buffer) IU/L 37°C 230 189 271
FEFE-0XXX IRON FERENE NIST SRM 937 μg/dL 266 218 314 manual measurement
Ferene
μmol/L 47.6 39.0 56.2 IFCC formulation (Schumann,2002),
ALSL-0850 ALT ENVOY IFCC without pyridoxal-phosphate IU/L 37°C 137.2 112.5 161.9
manual measurement
LACT-0XXX LACTATE Enzymatic colorimetric Primary reference material mg/dL 49.9 40.9 58.9
IFCC formulation (Schumann,2006),
(Lactate oxidase PAP) (weighed in purified material) mmol/L 5.54 4.54 6.54 AMSL-0850 AMYLASE ENVOY CNP-G3 Substrate
manual measurement
IU/L 37°C 237 194 280

IFCC formulation (Schumann, 2002), IFCC formulation (Schumann,2002),


LLSL-0XXX LDH-L SL IFCC (LĺP) IU/L 37°C 333 273 393 ASVD-0850 AST ENVOY IFCC without pyridoxal-phosphate IU/L 37°C 130.7 107.2 154.2
manual measurement manual measurement
BITV-0850 TOTAL BILIRUBIN ENVOY Diazo (blanked) NIST SRM 916a mg/dL 7.86 6.44 9.28
LPSL-0XXX LIPASE Enzymatic colorimetric Manual measurement IU/L 37°C 100 82 118 μmol/L 134.5 110.3 158.7
BIDV-0850 DIRECT BILIRUBIN ENVOY Diazo (blanked) Jendrassik-Grof Manual method mg/dL 7.10 5.40 8.80
MAGN-0XXX MAGNESIUM CALMAGITE Calmagite Atomic absorption mg/dL 3.29 2.89 3.69 μmol/L 121.4 92.3 150.5
mmol/L 1.36 1.20 1.52 CALA-0850 CALCIUM ENVOY Arsenazo NIST SRM 956c mg/dL 12.08 10.63 13.53
MAGX-0XXX MAGNESIUM XYLIDYL Xylidyl Blue Atomic absorption mg/dL 3.22 2.83 3.61 mmol/L 3.01 2.65 3.37
mmol/L 1.33 1.17 1.49 3918-006 CHLORIDE ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 113.8 102.4 125.2
mmol/L 113.8 102.4 125.2
PHOS-0XXX PHOSPHORUS Phosphomolybdate UV Primary reference material mg/dL 7.13 6.06 8.20
CHSL-0850 CHOLESTEROL ENVOY Enzymatic colorimetric (CHOD-PAP) ) ID-GC-MS mg/dL 183 156 210
(NERL/weighed in purified material) mmol/L 2.30 1.95 2.65 mmol/L 4.73 4.02 5.44
3918-005 POTASSIUM I.S.E Indirect Potentiometry NIST SRM 918b mEq/L 6.31 5.68 6.94 HDLL-0850 HDL CHOLESTEROL ENVOY CDC mg/dL 50 42 58
Colorimetric, end point
mmol/L 6.31 5.68 6.94 mmol/L 1.29 1.10 1.48
3918-004 SODIUM I.S.E Indirect Potentiometry NIST SRM 919b mEq/L 146.7 132.0 161.4 LDLL-0850 LDL CHOLESTEROL ENVOY CDC mg/dL 98 83 113
Colorimetric, end point
mmol/L 2.55 2.17 2.93
mmol/L 146.7 132.0 161.4
IFCC formulation (Schumann,2002),
PROB-0XXX TOTAL PROTEIN PLUS Biuret NIST SRM 909c g/dL 7.18 6.32 8.04 CKSL-0850 CK ENVOY IFCC
manual measurement
IU/L 37°C 305 250 360
g/L 71.8 63.2 80.4 CRSL-0850 CREATININE ENVOY Enzymatic colorimetric (PAP) ID-MS mg/dL 3.69 3.02 4.36
TGML-0XXX TRIGLYCERIDES SL mg/dL 197 166 228 μmol/L 327 268 386
Enzymatic colorimetric (GPO-PAP) ID-GC-MS
TRIGLYCERIDES MONO SL NEW mmol/L 2.22 1.86 2.58 GISL-0850 GGT ENVOY IFCC
IFCC formulation (Schumann,2002),
IU/L 37°C 213.2 174.8 251.6
manual measurement
URSL-0XXX UREA UV SL Enzymatic UV ID-MS mg/dL 116.0 98.6 133.4
GPSL-0850 GLUCOSE ENVOY Enzymatic colorimetric (GOD-PAP) ID-MS mg/dL 222.4 189.0 255.8
Urease / GLDH mmoL/L 19.32 16.42 22.22
mmol/L 12.34 10.49 14.19
AUML-0XXX URIC ACID MONO SL Enzymatic colorimetric ID-MS mg/dL 10.68 9.08 12.28 FEFE-0850 IRON ENVOY Ferene NIST SRM 937 μg/dL 266 218 314
(uricase-POD) μmol/L 635 540 730 μmol/L 47.6 39.0 56.2
AUSL-0XXX URIC ACID SL Enzymatic colorimetric ID-MS mg/dL 9.55 8.12 10.98 LPSL-0850 LIPASE ENVOY Enzymatic Colorimetric manual measurement IU/L 37°C 109 89 129
(uricase-POD) μmol/L 568 483 653
IFCC formulation (Schumann,2002),
LLSL-0850 LDH ENVOY IFCC (L ĺ P) IU/L 37°C 323 265 381
manual measurement
The values are defined with ELITech reagents ) : Modification from previous version MAGX-0850 MAGNESIUM ENVOY Xylidyl Blue Atomic absorption mg/dL 3.29 2.90 3.68
mmol/L 1.35 1.19 1.51
SRM: Standard Reference Material IFCC: International Federation of Clinical Chemistry and Laboratory Medicine PHOS-0850 PHOSPHORUS ENVOY Phosphomolybdate UV Primary reference material mg/dL 7.13 6.06 8.20
(NERL/weighed in purified material) mmol/L 2.30 1.95 2.65
ERM: European Reference Material DGKC: Deutsche Gesellschaft für Klinische Chemie
3918-005 POTASSIUM ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 6.65 5.98 7.32
ID-GC-MS: Isotope Dilution – Gas Chromatography –Mass Spectrometry SFBC: Société Française Biologie Clinique
mmol/L 6.65 5.98 7.32
ID-MS: Isotope Dilution – Mass Spectrometry CDC: Centers for Disease Control and Prevention 3918-004 SODIUM ENVOY I.S.E Indirect Potentiometry NIST SRM 956d mEq/L 148.8 133.9 163.7
mmol/L 148.8 133.9 163.7
PROB-0850 TOTAL PROTEIN ENVOY Biuret NIST SRM 909c g/dL 7.18 6.32 8.04
g/L 71.8 63.2 80.4
TGML-0850 TRIGLYCERIDES ENVOY Enzymatic colorimetric (GOD-PAP) ) ID-GC-MS mg/dL 205 172 238
mmol/L 2.32 1.95 2.69
URSL-0850 UREA ENVOY Enzymatic UV Urease/GLDH ID-MS mg/dL 116.0 98.6 133.4
mmol/L 19.31 16.41 22.21
AUVD-0850 URIC ACID ENVOY Uricase NIST SRM 913a mg/dL 10.57 8.98 12.16
μmol/L 629 535 723

The values are defined with ELITech reagents ) : Modification from previous version

SRM: Standard Reference Material )ID-GC-MS: Isotope Dilution – Gas Chromatography –Mass Spectrometry
ERM: European Reference Material IFCC: International Federation of Clinical Chemistry and Laboratory Medicine
ID-MS: Isotope Dilution – Mass Spectrometry CDC: Centers for Disease Control and Prevention

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