Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40391
371 Level 1 12 x 5 mL
0459 2022-12-31 40390 Level 2 40392
372 Level 2 12 x 5 mL
Level 3 40393
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

http://www.myeinserts.com/40390

INTENDED USE LIMITATIONS

Lyphochek Immunoassay Plus Control is intended for use as an assayed quality 1. This product should not be used past the expiration date.
control serum to monitor the precision of laboratory testing procedures for the 2. If there is evidence of microbial contamination or excessive turbidity in the
analytes listed in this package insert. reconstituted product, discard the vial.
SUMMARY AND PRINCIPLE 3. This product is not intended for use as a standard.
The use of quality control materials is indicated as an objective assessment of WARNING
the precision of methods and techniques in use and is an integral part of good
laboratory practices. Multiple levels of control are available to allow monitoring Biological source material. Treat as potentially infectious.
of the test system’s reliability. Each human donor unit used to manufacture this product was tested as required
For customers in Germany: Quality control materials are required for assessment by FDA accepted methods. Tests results were non-reactive or negative for
of laboratory performance as described in the “Guideline for Quality Assurance evidence of infection due to Human Immunodeficiency Virus (HIV), Hepatitis B
of Medical Laboratory Examinations following the German Medical Association” Virus (HBV) and Hepatitis C Virus (HCV). This product may also contain other
(Rili-BÄK regulation). human source materials for which there are no approved tests. In accordance
REAGENT with good laboratory practice, all human source material should be considered
This product is prepared from human serum with added chemicals, constituents potentially infectious and handled with the same precautions used with
of human and animal origin, therapeutic drugs and stabilizers. This product is patient specimens.
provided in lyophilized form for increased stability. Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
STORAGE AND STABILITY SPECIFIC PERFORMANCE CHARACTERISTICS
This product will be stable until the expiration date when stored This product is a freeze-dried product manufactured under rigid quality control
unopened at 2 to 8°C. standards. To obtain consistent assay values, the control requires proper storage
Reconstituted and Refrigerated: After reconstituting and storing tightly capped and handling as described.
at 2 to 8°C, this product will be stable as follows: ASSIGNMENT OF VALUES
- All analytes: 7 days The mean values and corresponding ±3SD ranges in the Assignment of Values
Except: Data Charts (available separately) were derived from replicate analyses and are
- Folate and PSA (Total): 3 days at 2 to 8°C specific for this lot of product. Data from Unity™ Interlaboratory Program are
- C-Peptide: 1 day at 2 to 8°C included in the determination of some ranges. The tests listed were performed
- ACTH, Calcitonin, Gastrin and PSA (Free): After reconstituting, according to the by the manufacturer and/or independent laboratories using manufacturer
instructions in the Procedure Section, assay immediately. supported reagents and a representative sampling of this lot of product. It is
Reconstituted and Frozen: When reconstituted and stored tightly capped recommended that each laboratory establish its own acceptable ranges and use
at -20 to -70°C, this product will be stable as follows: those provided only as guides. Laboratory established ranges may vary from
- All analytes: 20 days those listed during the life of this control. [Customers in Germany have to follow
Except: the requirements as described in the Rili-BÄK regulation.] Variations over time
- ACTH, Aldosterone, Calcitonin and C-Peptide: No frozen stability provided. and between laboratories may be caused by differences in laboratory technique,
Once thawed, do not refreeze this product. Discard the remaining material. instrumentation and reagents, or by manufacturer test method modifications.
This product is shipped under ambient conditions.
PROCEDURE Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
This product should be treated the same as patient specimens and run in holding more than 2 billion QC data points from thousands of laboratories.
accordance with the instructions accompanying the instrument, kit, or reagent INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
being used. The Data Charts are available through the Internet, at
Using a volumetric pipet or equivalent, reconstitute each vial with 5.0 mL of www.myeinserts.com/40390. Follow the directions at the website to receive
distilled or deionized water. Replace the stopper and allow this product to stand email notifications of insert updates. Alternate methods for receiving data charts
for approximately 15 minutes swirling occasionally. are available by contacting your local Bio-Rad Laboratories Office.
Before sampling, allow this product to reach room temperature (18 to 25°C).
Gently swirl the vial several times to ensure homogeneity. After each use,
promptly replace the stopper and return to 2 to 8°C storage.
Dispose of any discarded materials in accordance with the requirements of your
local waste management authorities. In the event of damage to packaging,
contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories
Technical Services.

Page 1 English • 2020-03 • 1536-00

 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3
ANALYTES
11-Deoxycortisol Dehydroepiandrosterone-Sulfate Immunoglobulin E (IgE) PTH (Intact) ❑
17-Alpha-Hydroxyprogesterone (DHEA-Sulfate) Immunoglobulin G (IgG) ◆ Quinidine ❍
25-Hydroxy Vitamin D ◆ Desipramine ❍ Immunoglobulin M (IgM) ◆ Salicylate
Acetaminophen Digoxin Immunoreactive Trypsinogen (IRT) ❑ Sex Hormone Binding Globulin
ACTH Disopyramide Insulin (SHBG) ❑

AFP Estradiol Iron ◆ T3 (Free)

Aldosterone Estriol (Free) Iron (TIBC) ◆ T3 (Total)

Amikacin Estriol (Total) ❑ Lidocaine T3 Uptake/T Uptake

Amiodarone ❑ Estrogen (Total) Lithium T4 (Free)

Amitriptyline Ethosuximide Luteinizing Hormone (LH) T4 (Total)

Androstenedione Ferritin N-Acetyl Procainamide (NAPA) TCA Screen ❍

Angiotensin I ◆ ❑ Flecainide ❍ Netilmicin ❑ Testosterone

Anti-Tg ❑ Folate Nortriptyline Testosterone (Free)

Anti-Thyroperoxidase (Anti-TPO) ❑ Follicle Stimulating Hormone (FSH) Phenobarbital Theophylline

Caffeine Fructosamine ◆ ❍ Phenytoin Thyroglobulin (Tg) ◆

Calcitonin Gastrin Phenytoin (Free) ❍ Thyroid Stimulating Hormone (TSH)

Carbamazepine Gentamicin Primidone Thyroxine Binding Globulin (TBG) ◆

Carbamazepine (Free) ❍ Glucagon ❑ Procainamide Tobramycin

CEA hCG Progesterone Valproic Acid

Chloramphenicol hCG-Beta Subunit Prolactin Valproic Acid (Free) ❍

Cortisol Human Growth Hormone (hGH) Propranolol ❍ Vancomycin

C-Peptide IGF-1/Somatomedin C ◆ Prostatic Acid Phosphatase (PAP) Vitamin B12

Cyclosporine ❑ Imipramine PSA (Free)

Dehydroepiandrosterone (DHEA) ❑ Immunoglobulin A (IgA) ◆ PSA (Total)

NOTES
◆ Endogenous levels only.
❑ No claim is made for expected value or stability of this analyte.
❍ Values are not provided.

LEXICON

Reconstitute with

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© 2020 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2020-03 • 1536-00
 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
11-DEOXYCORTISOL (2)
DIAsource RIA CT ng/mL 0.925 0.648 – 1.20 2.85 1.99 – 3.70 3.89 2.73 – 5.06
17-ALPHA-HYDROXYPROGESTERONE (2)
Beckman Coulter RIA (IM1452) ng/mL 0.590 0.390 – 0.800 1.68 1.18 – 2.19 4.11 2.88 – 5.34
Calbiotech ELISA ng/mL 0.570 0.380 – 0.760 2.04 1.36 – 2.72 8.25 5.50 – 11.0
Diagnostics Biochem Canada ELISA ng/mL § § §
DiaMetra ELISA ng/mL 0.170 <0.200 – 0.330 1.32 0.820 – 1.81 3.78 2.64 – 4.91
DIAsource RIA CT ng/mL 0.907 0.635 – 1.18 2.25 1.58 – 2.93 4.98 3.48 – 6.47
DRG ELISA (EIA-1292) ng/mL 0.590 0.320 – 0.850 2.56 1.41 – 3.71 7.44 4.09 – 10.8
IBL ELISA ng/mL 0.490 0.170 – 0.810 2.01 1.11 – 2.91 6.74 3.70 – 9.77
IBL RIA ng/mL § § §
Monobind AccuBind ELISA ng/mL 1.08 0.730 – 1.44 3.63 2.43 – 4.82 >10.0
Monobind AccuLite CLIA ng/mL 1.06 0.710 – 1.41 3.72 2.49 – 4.95 >10.0
MP BioMedicals ImmuChem CT RIA ng/mL
MP BioMedicals ImmuChem DA RIA ng/mL
ACETAMINOPHEN (2)
Cambridge Life Sciences Paracetamol (K8003) µg/mL 10.7 7.55 – 13.9 36.4 29.2 – 43.8 107 85.3 – 128
SEKURE (Sekisui Diagnostics) µg/mL 10.0 7.00 – 13.0 36.0 27.0 – 45.0 105 79.0 – 131
ACTH (2)
Beckman Coulter IRMA (IM2030) (5) pg/mL 17.3 12.1 – 22.4 135 94.7 – 176 115 80.6 – 150
Biomerica ELISA pg/mL 23.5 12.7 – 34.2 182 107 – 256 127 67.3 – 188
BRAHMS Diagnostica RIA (5) pg/mL 23.0 18.0 – 28.0 212 171 – 253 184 156 – 212
Cisbio Bioassays (5) pg/mL 90.0 62.0 – 118 810 630 – 990 820 650 – 990
AFP (2)
Beckman Coulter IRMA (IM1441) ng/mL 22.8 17.1 – 28.6 108 80.8 – 135 240 180 – 300
Beckman Coulter Screening IRMA (A37404) ng/mL 22.0 16.5 – 27.5 116 87.3 – 146 252 189 – >265
Calbiotech ELISA ng/mL 11.7 7.79 – 15.6 80.8 53.8 – 108 181 120 – 241
Cisbio Bioassays ng/mL 23.2 18.5 – 27.9 143 114 – 172 265 210 – 320
Cisbio Bioassays RIA-gnost IU/mL 15.5 12.4 – 18.6 76.0 60.0 – 92.0 150 120 – 180
DiaMetra ELISA ng/mL 18.7 13.1 – 24.4 72.6 50.9 – 94.4 102 71.5 – 133
DRG ELISA (EIA-1468) ng/mL 29.6 19.5 – 39.6 141 93.4 – 189 >193
Fortress Diagnostics ng/mL
HUMAN ELISA ng/mL 20.3 13.6 – 26.9 96.0 64.3 – 128 230 165 – 295
IBL ELISA IU/mL 25.0 16.0 – 33.0 117 78.0 – 157 >160
Institute of Isotopes IRMA IU/mL 13.3 10.6 – 15.9 68.9 55.1 – 82.7 152 122 – 182
Monobind AccuBind ELISA ng/mL 20.3 13.6 – 26.9 96.0 64.3 – 128 230 165 – 295
Monobind AccuLite CLIA ng/mL 18.4 12.3 – 24.5 103 69.2 – 137 244 163 – 324
ALDOSTERONE (2)
Beckman Coulter RIA (DSL8600) pg/mL 153 107 – 199 328 230 – 427 805 564 – 1047
Beckman Coulter RIA (IM1664) pg/mL 103 61.8 – 144 182 118 – 246 343 206 – 480
Cisbio Bioassays pg/mL 96.0 74.0 – 118 118 94.0 – 142 270 210 – 330
DiaMetra ELISA pg/mL 124 60.8 – 187 341 238 – 443 723 506 – 939
DIAsource RIA CT ng/dL 10.9 7.78 – 13.9 20.9 16.4 – 25.5 53.4 45.6 – 61.2
DRG ELISA (EIA-5298) pg/mL 90.1 49.6 – 131 272 150 – 394 795 437 – 1153
IBL ELISA pg/mL 90.0 50.0 – 131 272 150 – 394 795 437 – 1153
IBL RIA pg/mL § § §
AMITRIPTYLINE
HPLC ng/mL § § §
ANDROSTENEDIONE (2)
Beckman Coulter RIA (DSL3800) ng/mL 0.550 0.360 – 0.740 1.49 1.05 – 1.94 2.77 1.94 – 3.60
Beckman Coulter RIA Delta4 (IM0674) ng/mL 1.15 0.810 – 1.50 2.68 1.87 – 3.48 4.46 3.12 – 5.80
Calbiotech ELISA ng/mL 1.64 1.09 – 2.18 4.11 2.74 – 5.48 7.58 5.05 – >10.0
Diagnostics Biochem Canada ELISA ng/mL § § §
DiaMetra ELISA ng/mL 0.360 0.220 – 0.500 1.83 1.28 – 2.38 2.90 2.03 – 3.77
DIAsource RIA CT ng/mL 0.788 0.560 – 1.02 2.39 1.94 – 2.83 4.37 3.42 – 5.31
DRG ELISA (EIA-3265) ng/mL 0.520 0.290 – 0.750 1.57 0.860 – 2.27 4.50 2.47 – 6.52

Page 3 English • 2020-03 • 1536-00

7
 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
ANDROSTENEDIONE (2) (continued)
IBL ELISA ng/mL 0.520 0.290 – 0.750 1.60 0.900 – 2.30 4.50 2.50 – 6.50
IBL RIA ng/mL § § §
MP BioMedicals ImmuChem DA RIA ng/mL
Siemens Atellica Solution ng/mL 0.558 0.295 – 0.821 1.11 0.667 – 1.55 1.75 1.10 – 2.39
CALCITONIN (2)
Biomerica ELISA pg/mL 59.4 50.8 – 68.0 330 284 – 375 555 433 – 676
Cisbio Bioassays pg/mL 59.0 47.0 – 71.0 252 194 – 310 380 300 – 460
DIAsource CT US IRMA 2nd IS 89/620 pg/mL 51.1 39.1 – 63.2 287 256 – 319 426 376 – 475
EUROIMMUN IRMA CT pg/mL 31.0 23.0 – 39.0 214 161 – 267 352 264 – 440
IBL RIA pg/mL 34.9 27.9 – 41.9 237 190 – 284 421 336 – 505
Institute of Isotopes IRMA pg/mL 28.1 21.1 – 35.2 188 150 – 225 332 265 – 398
Siemens Atellica Solution (CALCT) (IM) pg/mL 25.8 11.5 – 40.0 222 161 – 282 419 311 – 526
CARBAMAZEPINE (2)
CEDIA II µg/mL
Sekisui Medical Nanopia µg/mL 2.72 1.63 – 3.81 7.56 5.29 – 9.83 13.0 10.4 – 15.6
CEA (2)
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 1.08 0.710 – 1.43 9.88 6.59 – 13.2 29.0 19.4 – 38.7
Cisbio Bioassays ng/mL 1.55 1.24 – 1.86 10.9 8.70 – 13.1 35.0 28.0 – 42.0
DiaMetra ELISA ng/mL <5.00 14.7 10.3 – 19.1 32.9 23.0 – 42.8
DIAsource IRMA ng/mL 2.16 1.51 – 2.80 20.4 14.3 – 26.6 58.1 40.7 – 75.5
HUMAN ELISA ng/mL 1.78 1.19 – 2.37 14.6 9.80 – 19.4 27.7 17.3 – 38.1
Institute of Isotopes IRMA ng/mL 1.70 1.28 – 2.13 11.1 8.90 – 13.3 28.8 23.1 – 34.6
Monobind AccuBind (NG ELISA) ng/mL <2.00 11.4 7.66 – 15.2 22.3 15.0 – 29.7
Monobind AccuBind ELISA ng/mL 1.78 1.19 – 2.37 14.6 9.80 – 19.4 27.7 17.3 – 38.1
Monobind AccuLite (NG CLIA) ng/mL <2.00 10.1 6.79 – 13.5 18.6 12.4 – 24.7
Monobind AccuLite CLIA ng/mL 1.68 1.12 – 2.23 12.4 8.27 – 16.4 27.8 18.6 – 37.0
CHLORAMPHENICOL
HPLC µg/mL § § §
CORTISOL (2)
Beckman Coulter RIA (IM1841) µg/dL 4.67 3.51 – 5.83 16.9 12.7 – 21.2 28.5 21.4 – 35.7
Calbiotech ELISA ng/mL 46.2 30.8 – 61.6 193 129 – 257 402 268 – 536
Cisbio Bioassays µg/dL 3.41 2.72 – 4.09 13.4 10.5 – 16.3 22.5 17.8 – 27.2
DIALAB Cortisol ng/mL 37.9 27.7 – 48.1 273 224 – 322 488 419 – 558
DiaMetra ELISA ng/mL 26.7 16.3 – 37.2 219 153 – 285 500 350 – >500
DIAsource RIA CT µg/dL 5.08 3.56 – 6.61 16.0 11.2 – 20.8 30.2 21.1 – 39.2
DRG ELISA (EIA-1887) ng/mL 43.7 28.0 – 59.5 197 126 – 267 379 243 – 516
HUMAN ELISA ng/mL 43.7 28.0 – 59.5 197 126 – 267 379 243 – 516
IBL RIA µg/dL § § §
IBL Serum ELISA ng/mL 45.4 29.5 – 61.2 196 127 – 265 379 246 – 512
Institute of Isotopes IRMA ng/mL 41.7 31.2 – 52.2 149 119 – 179 253 202 – 303
Monobind AccuBind ELISA µg/dL 4.45 2.98 – 5.92 16.6 11.1 – 22.1 29.3 19.6 – 39.0
Monobind AccuLite CLIA µg/dL 4.86 3.26 – 6.46 16.4 11.0 – 21.9 31.6 21.2 – 42.1
MP BioMedicals Corti-Cote RIA µg/dL
MP BioMedicals ImmuChem CT RIA µg/dL
C-PEPTIDE (2)
Beckman Coulter IRMA (IM3639) ng/mL 1.16 0.811 – 1.50 5.83 4.08 – 7.57 9.37 6.56 – 12.2
Calbiotech ELISA ng/mL 0.930 0.620 – 1.24 4.83 3.22 – 6.44 7.37 4.91 – 9.82
Cisbio Bioassays ng/mL 1.35 1.08 – 1.62 7.12 5.68 – 8.56 11.7 9.31 – 14.1
DIAsource C-PEP II RIA CT ng/mL 1.12 0.862 – 1.38 4.56 3.60 – 5.56 6.46 4.53 – 8.41
DRG ELISA (EIA-1293) ng/mL 0.660 0.360 – 0.950 4.51 2.48 – 6.54 7.13 3.92 – 10.3
IBL ELISA ng/mL 0.660 0.360 – 0.950 4.51 2.48 – 6.54 7.13 3.92 – 10.3
Institute of Isotopes IRMA ng/mL 1.33 1.00 – 1.67 6.60 5.30 – 7.90 10.9 8.80 – 13.1
Monobind AccuBind ELISA ng/mL 0.710 0.480 – 0.950 3.39 2.27 – 4.51 5.38 3.61 – 7.16
Monobind AccuLite CLIA ng/mL 0.670 0.450 – 0.880 3.33 2.23 – 4.43 5.22 3.50 – 6.95

Page 4 English • 2020-03 • 1536-00

7
 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
DEHYDROEPIANDROSTERONE-SULFATE (DHEA-SULFATE) (2)
Beckman Coulter RIA (IM0729) µg/dL 80.8 60.6 – 101 155 116 – 194 719 503 – 935
Beckman Coulter RIA DHEA-S-7 (DSL2700) ng/mL 694 486 – 903 1689 1182 – 2196 5365 3219 – 7511
Calbiotech ELISA µg/mL 1.30 0.870 – 1.74 2.37 1.58 – 3.16 9.03 6.02 – 12.0
DiaMetra ELISA µg/mL 0.860 0.590 – 1.12 1.69 1.18 – 2.20 4.93 3.25 – 6.61
DIAsource RIA CT µg/dL 101 79.8 – 122 188 145 – 232 627 439 – 815
DRG ELISA (EIA-1562) µg/mL 0.640 0.350 – 0.940 1.69 0.930 – 2.44 5.77 3.17 – 8.37
HUMAN ELISA µg/mL 0.640 0.350 – 0.940 1.69 0.930 – 2.44 5.77 3.17 – 8.37
IBL ELISA µg/mL 0.880 0.570 – 1.19 1.95 1.27 – 2.64 7.72 5.02 – 10.4
Institute of Isotopes IRMA µg/mL 0.889 0.667 – 1.15 1.59 1.26 – 1.93 5.85 4.67 – 7.00
Monobind AccuBind ELISA µg/mL 0.830 0.560 – 1.10 1.99 1.33 – 2.65 6.73 4.51 – >8.00
Monobind AccuLite CLIA µg/mL 0.930 0.620 – 1.23 2.17 1.38 – 2.95 >8.00
MP BioMedicals ImmuChem CT RIA ng/mL
DESIPRAMINE
HPLC ng/mL § § §
DIGOXIN (2)
Monobind AccuBind ELISA ng/mL 0.850 0.570 – 1.14 2.32 1.56 – 3.09 3.80 2.55 – >4.00
Monobind AccuLite CLIA ng/mL 0.820 0.550 – 1.09 2.22 1.49 – 2.95 3.73 2.50 – >4.00
Sekisui Medical Nanopia ng/mL 0.722 0.433 – 1.01 1.97 1.38 – 2.56 3.42 2.74 – 4.10
DISOPYRAMIDE
Emit µg/mL § § §
ESTRADIOL (2)
Beckman Coulter RIA (A21854) pg/mL 67.8 40.7 – 94.9 96.5 57.9 – 135 169 110 – 229
Beckman Coulter RIA US Estradiol (DSL4800) pg/mL 60.9 39.6 – 82.2 83.8 54.5 – 113 151 98.3 – 204
BioCheck EIA pg/mL § § §
Calbiotech ELISA pg/mL 86.2 57.5 – 115 256 171 – 342 771 514 – >1000
Cisbio Bioassays pg/mL 68.0 38.0 – 98.0 277 214 – 340 640 510 – 770
Cisbio Bioassays ESTR-US-CT pg/mL 51.0 40.6 – 61.3 76.3 59.9 – 92.6 147 117 – 177
DIALAB 17-beta pg/mL 99.3 75.5 – 123 261 214 – 308 634 569 – 698
DiaMetra ELISA (17 Beta) pg/mL 152 106 – 197 306 214 – 398 649 454 – 844
DIAsource E2 RIA CT pg/mL 79.0 58.0 – 101 144 101 – 188 306 217 – 394
DRG ELISA (EIA-2963) pg/mL 134 75.3 – 194 382 214 – 550 747 418 – 1076
HUMAN ELISA pg/mL 221 124 – 318 565 316 – 813 1037 581 – 1493
IBL ELISA pg/mL 134 75.0 – 194 382 214 – 550 747 418 – 1076
Monobind AccuBind ELISA pg/mL 99.1 66.4 – 132 183 122 – 243 361 242 – 480
Monobind AccuLite CLIA pg/mL 99.1 66.4 – 132 189 127 – 242 356 236 – 477
MP BioMedicals ImmuChem CT RIA pg/mL
MP BioMedicals ImmuChem DA RIA pg/mL
Pantex 100 uL Direct 125I pg/mL § § §
ESTRIOL (FREE) (2)
Beckman Coulter RIA (IM3594) ng/mL 0.760 0.450 – 1.06 1.92 1.15 – 2.69 5.31 3.19 – 7.44
Calbiotech ELISA ng/mL 4.32 2.88 – 5.76 11.5 7.68 – 15.4 16.9 11.3 – 22.6
DiaMetra ELISA ng/mL
DRG ELISA (EIA-1612) ng/mL 2.02 1.11 – 2.93 6.10 3.37 – 8.89 12.8 7.05 – 18.6
HUMAN ELISA ng/mL 1.54 0.840 – 2.23 3.68 2.02 – 5.33 10.7 5.90 – 15.6
IBL ELISA Unconjugated ng/mL 2.00 1.10 – 2.90 6.10 3.40 – 8.90 12.8 7.10 – 18.6
Monobind AccuBind ELISA ng/mL 3.39 2.27 – 4.51 10.0 6.72 – 13.4 14.1 9.42 – 18.7
Monobind AccuLite CLIA ng/mL 3.63 2.43 – 4.83 9.40 6.30 – 12.5 14.0 9.40 – 18.7
ESTROGEN (TOTAL) (2)
MP BioMedicals ImmuChem DA RIA pg/mL
ETHOSUXIMIDE
Emit µg/mL § § §
FERRITIN (2)
Beckman Coulter IRMA (IM3492) ng/mL 69.9 48.9 – 90.9 158 110 – 205 376 263 – 489
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 54.0 36.0 – 72.0 133 88.9 – 178 373 249 – 498

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
FERRITIN (2) (continued)
DiaMetra ELISA ng/mL 76.3 57.6 – 95.0 208 138 – 277 519 324 – 713
Monobind AccuBind ELISA ng/mL 83.2 55.7 – 111 164 110 – 219 366 246 – 487
Monobind AccuLite CLIA ng/mL 65.6 43.9 – 87.2 175 107 – 242 402 269 – 534
FOLATE (2)
MP BioMedicals SimulTRAC SNB RIA ng/mL
MP BioMedicals SimulTRAC SP RIA ng/mL
FOLLICLE STIMULATING HORMONE (FSH) (2)
Beckman Coulter IRMA (IM2125) mIU/mL 4.04 3.03 – 5.05 14.1 10.6 – 17.6 26.1 19.6 – 32.6
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 3.11 2.07 – 4.15 11.7 7.81 – 15.6 23.0 15.3 – 30.7
DIALAB FSH mIU/mL 6.84 2.74 – 11.0 26.3 18.0 – 34.7 48.0 33.0 – 63.0
DiaMetra ELISA mIU/mL 6.17 <5.00 – 8.02 23.4 16.4 – 30.4 50.8 35.6 – 66.1
DIAsource IRMA mIU/mL 3.48 2.31 – 4.64 20.4 17.2 – 23.6 38.7 30.5 – 46.8
DRG ELISA (EIA-1288) mIU/mL 5.59 3.07 – 8.10 21.3 11.7 – 30.9 41.8 23.0 – 60.6
Fortress Diagnostics mIU/mL
HUMAN ELISA mIU/mL 5.97 4.00 – 7.94 21.7 14.5 – 28.8 48.9 32.8 – 65.1
IBL ELISA mIU/mL 5.60 3.10 – 8.10 21.3 11.7 – 30.9 41.8 23.0 – 60.6
Institute of Isotopes IRMA mIU/mL 7.00 5.20 – 8.70 25.2 20.2 – 30.2 49.4 39.5 – 59.3
Monobind AccuBind ELISA mIU/mL 5.97 4.00 – 7.94 21.7 14.5 – 28.8 48.9 32.8 – 65.1
Monobind AccuLite CLIA mIU/mL 5.59 3.74 – 7.43 21.7 14.6 – 28.9 49.3 33.0 – 65.6
GASTRIN (2)
Cisbio Bioassays GASK-PR µIU/mL 53.0 36.0 – 70.0 256 202 – 310 520 410 – 630
MP BioMedicals RIA pg/mL
GENTAMICIN (2)
CEDIA II µg/mL
HCG (2)
Beckman Coulter IRMA (IM2110) mIU/mL <10.4 24.1 18.0 – 30.1 170 127 – 212
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 3.89 2.59 – 5.18 17.7 11.8 – 23.6 167 112 – 223
Cisbio Bioassays mIU/mL 8.80 7.00 – 10.6 26.7 20.4 – 33.0 196 156 – 236
DIAsource hCG + Beta IRMA mIU/mL 10.3 7.20 – 13.4 50.6 35.4 – 65.8 262 213 – 312
DRG ELISA (EIA-1469) mIU/mL 26.8 16.6 – 37.0 151 93.6 – 208
HUMAN ELISA mIU/mL 6.80 4.55 – 9.04 22.4 15.0 – 29.8 181 121 – 240
Institute of Isotopes IRMA (ßhCG) mIU/mL 5.80 4.35 – 7.26 25.8 20.7 – 31.0 197 157 – 236
Monobind AccuBind ELISA mIU/mL 6.80 4.55 – 9.04 22.4 15.0 – 29.8 181 121 – 240
Monobind AccuLite CLIA mIU/mL 5.39 3.61 – 7.16 22.5 15.1 – 30.0 167 112 – 223
HCG-BETA SUBUNIT (2)
Cisbio Bioassays ng/mL 0.070 0.050 – 0.090 0.100 0.080 – 0.120 0.830 0.660 – 1.00
DiaMetra ELISA mIU/mL 1.00 <1.00 – 1.40 8.83 6.18 – 11.5 146 98.3 – 193
DRG ELISA (EIA-1911) mIU/mL 3.46 2.15 – 4.78 12.7 7.85 – 17.5 73.2 45.4 – 101
IBL ELISA mIU/mL 3.50 2.20 – 4.80 12.7 7.90 – 17.5 73.0 45.0 – 101
HUMAN GROWTH HORMONE (HGH) (2)
Beckman Coulter IRMA (IM1397) µIU/mL 8.66 6.50 – 10.8 23.3 18.7 – 28.0 47.0 37.6 – 56.4
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 3.22 2.14 – 4.29 13.6 9.05 – 18.1 28.2 18.8 – 37.7
Cisbio Bioassays ng/mL 2.98 2.36 – 3.60 8.20 6.50 – 9.90 15.6 12.4 – 18.8
DiaMetra ELISA µIU/mL
DIAsource IRMA µIU/mL 6.35 4.76 – 7.94 17.8 13.1 – 22.6 38.6 27.8 – 49.3
Institute of Isotopes IRMA µIU/mL 10.0 7.50 – 12.5 27.8 22.2 – 33.3 56.1 44.9 – 67.3
MEDIAGNOST ELISA µIU/mL 9.60 8.10 – 11.2 27.5 23.9 – 31.0 53.6 43.8 – 63.4
Monobind AccuBind ELISA µIU/mL 3.77 2.53 – 5.01 9.37 6.28 – 12.5 21.0 14.1 – 27.9
Monobind AccuLite CLIA µIU/mL 3.39 2.27 – 4.51 9.26 6.20 – 12.3 21.5 14.4 – 28.6
MP BioMedicals ImmuChem DA RIA ng/mL
IGF-1/SOMATOMEDIN C (2)
Beckman Coulter IGF-1 RIA ng/mL § § §

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
IGF-1/SOMATOMEDIN C (2) (continued)
MEDIAGNOST IGF-1 ELISA (IGFBP Blocked) ng/mL 118 92.0 – 144 126 105 – 146 112 92.0 – 131
MEDIAGNOST IGF-1 RIA (IGFBP Blocked) ng/mL 118 92.0 – 144 126 105 – 146 112 92.0 – 131
IMIPRAMINE
HPLC ng/mL § § §
IMMUNOGLOBULIN E (IGE)
BioCheck EIA (2) IU/mL § § §
Calbiotech ELISA (2) IU/mL >400 66.5 44.3 – 88.7 122 81.3 – 163
DiaMetra ELISA (2) IU/mL 361 279 – >400 84.5 59.2 – 110 117 81.6 – 152
EUROIMMUN Total IgE ELISA (2) IU/mL 297 208 – 386 71.8 50.2 – 93.3 90.1 63.1 – 117
ImmunoCAP total IgE IU/mL § § §
Monobind AccuBind ELISA (2) IU/mL 370 248 – >400 86.1 57.7 – 115 105 70.1 – 139
Monobind AccuLite CLIA (2) IU/mL 389 227 – >400 81.1 54.3 – 108 101 67.7 – 134
INSULIN (2)
Beckman Coulter IRMA (IM3210) µIU/mL 16.2 12.1 – 20.2 55.7 41.8 – 69.7 170 136 – 204
Calbiotech ELISA µIU/mL 16.7 11.2 – 22.3 60.7 46.8 – 74.7 >100
Cias INSULIN II and BIO Majesty 1650 µIU/mL 16.3 13.0 – 19.6 54.1 46.0 – 62.2 >100
Cisbio Bioassays BI-Insulin IRMA µIU/mL 18.8 15.0 – 22.6 65.0 52.0 – 78.0 201 160 – 242
DiaMetra ELISA µIU/mL 17.2 12.0 – 22.3 53.3 34.1 – 72.4 154 103 – 205
DIAsource IRMA µIU/mL 17.7 12.8 – 22.6 61.2 42.8 – 79.5 195 139 – 251
DRG ELISA (EIA-2935) µIU/mL 17.0 9.38 – 24.7 56.9 31.3 – 82.6 >100
Institute of Isotopes IRMA µIU/mL 19.2 14.4 – 24.0 63.2 50.5 – 75.8 156 125 – 187
Monobind AccuBind ELISA µIU/mL 11.8 7.89 – 15.7 44.0 29.5 – 58.5 132 88.6 – 176
Monobind AccuLite CLIA µIU/mL 11.0 7.38 – 14.7 42.3 28.3 – 56.2 136 91.0 – 181
MP BioMedicals ImmuChem CT RIA µIU/mL
Sekisui Medical Norudia µIU/mL 12.3 9.84 – 14.8 47.7 38.2 – 57.3 144 115 – >150
LIDOCAINE
Emit µg/mL 1.30 <1.00 – 1.73 3.79 2.96 – 4.62 6.80 5.48 – 8.12
LUTEINIZING HORMONE (LH) (2)
Beckman Coulter IRMA (IM1381) mIU/mL 1.61 1.12 – 2.09 23.1 16.2 – 30.0 82.2 57.6 – 107
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 1.33 0.870 – 1.79 17.5 11.6 – 23.3 36.9 – >50.0
DIALAB LH mIU/mL <2.00 19.3 9.58 – 28.9 50.9 40.4 – 61.4
DiaMetra ELISA mIU/mL <5.00 17.9 12.5 – 23.3 68.9 48.2 – 89.6
DIAsource sp IRMA mIU/mL 0.750 0.530 – 0.980 9.40 6.60 – 12.2 39.9 27.9 – 51.9
DRG Serum ELISA (EIA-1289) mIU/mL 2.66 1.46 – 3.86 22.8 12.6 – 33.1 60.2 33.1 – 87.2
HUMAN ELISA mIU/mL 2.03 1.36 – 2.70 26.2 17.6 – 34.8 88.1 59.0 – 117
IBL ELISA mIU/mL 2.70 1.50 – 3.90 22.8 12.6 – 33.1 60.2 33.1 – 87.2
Institute of Isotopes IRMA mIU/mL 1.20 0.900 – 1.50 16.8 13.5 – 20.2 61.3 49.0 – 73.6
Monobind AccuBind ELISA mIU/mL 2.03 1.36 – 2.70 26.2 17.6 – 34.8 88.1 59.0 – 117
Monobind AccuLite CLIA mIU/mL <5.00 26.1 17.5 – 34.7 88.2 59.1 – 117
N-ACETYL PROCAINAMIDE (NAPA) (2)
CEDIA µg/mL
NORTRIPTYLINE
HPLC ng/mL § § §
PHENOBARBITAL (2)
CEDIA II µg/mL
Sekisui Medical Nanopia µg/mL 9.59 5.76 – 13.4 24.7 17.3 – 32.0 46.8 37.4 – 56.1
PHENYTOIN (2)
CEDIA II µg/mL
Sekisui Medical Nanopia µg/mL 7.84 4.70 – 11.0 14.4 10.1 – 18.8 26.8 21.5 – 32.2
PRIMIDONE
Emit µg/mL § § §
PROCAINAMIDE (2)
CEDIA µg/mL

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
PROGESTERONE (2)
Beckman Coulter RIA (IM1188) ng/mL 0.590 0.420 – 0.770 8.71 6.10 – 11.3 29.2 20.4 – 37.9
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL § § §
Diagnostics Biochem Canada ELISA ng/mL § § §
DIALAB Progesterone ng/mL 1.06 0.370 – 1.74 15.9 12.9 – 19.0 >42.0
DiaMetra ELISA ng/mL 1.01 0.620 – 1.41 21.7 15.2 – 28.3 >40.0
DIAsource RIA CT ng/mL 1.69 1.18 – 2.19 13.9 10.4 – 17.4 36.5 25.6 – 47.5
DRG ELISA (EIA-1561) ng/mL 0.980 0.540 – 1.42 12.1 6.63 – 17.5 35.9 23.4 – 48.5
HUMAN ELISA ng/mL 0.980 0.540 – 1.42 12.1 6.63 – 17.5 35.9 23.4 – 48.5
IBL ELISA ng/mL 0.980 0.540 – 1.42 12.1 6.60 – 17.5 35.9 23.4 – 48.5
Institute of Isotopes IRMA ng/mL 0.535 0.409 – 0.660 6.70 5.35 – 8.05 14.9 11.9 – 17.9
Monobind AccuBind ELISA ng/mL 1.42 0.940 – 1.91 12.5 8.36 – 16.6 31.0 20.8 – 41.3
Monobind AccuLite CLIA ng/mL 1.43 0.850 – 2.01 13.5 9.01 – 17.9 31.4 21.1 – 41.8
MP BioMedicals ImmuChem CT RIA ng/mL
MP BioMedicals ImmuChem DA RIA ng/mL
PROLACTIN (2)
Beckman Coulter IRMA (IM2121) ng/mL 4.51 3.16 – 5.86 13.5 10.1 – 16.9 27.0 20.3 – 33.8
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 7.01 4.67 – 9.34 21.6 14.4 – 28.8 46.5 31.0 – 62.0
DIALAB Prolactin ng/mL 6.01 2.60 – 9.42 14.7 7.26 – 22.1 29.3 18.7 – 40.0
DiaMetra ELISA ng/mL 6.22 <5.00 – 8.08 17.8 12.5 – 23.2 38.3 26.8 – 49.8
DIAsource IRMA ng/mL 2.90 2.03 – 3.77 11.2 7.86 – 14.6 22.5 15.7 – 29.2
DRG ELISA (EIA-1291) ng/mL 6.52 3.59 – 9.45 16.7 9.20 – 24.3 32.5 17.9 – 47.1
Fortress Diagnostics ng/mL
HUMAN ELISA ng/mL 8.55 5.73 – 11.4 24.8 16.6 – 32.9 53.2 35.6 – 70.8
Institute of Isotopes IRMA ng/mL 5.40 4.10 – 6.80 15.2 12.2 – 18.3 30.5 24.4 – 36.7
Monobind AccuBind ELISA ng/mL 9.44 6.32 – 12.6 26.5 17.7 – 35.2 59.8 40.1 – 79.6
Monobind AccuLite CLIA ng/mL 8.46 5.67 – 11.3 25.4 17.0 – 33.8 54.7 36.7 – 72.8
MP BioMedicals ImmuChem CT IRMA ng/mL
PROPRANOLOL
HPLC ng/mL § § §
PSA (FREE) (2)
Beckman Coulter IRMA (IM2520) ng/mL <0.310 1.32 0.990 – 1.65 8.99 6.74 – 11.2
Cisbio Bioassays ng/mL 0.240 0.190 – 0.290 1.53 1.22 – 1.84 9.80 7.80 – 11.8
DiaMetra ELISA ng/mL
HUMAN ELISA ng/mL 0.370 0.250 – 0.500 2.55 1.71 – 3.39 >10.0
IBL ELISA ng/mL § § §
Institute of Isotopes IRMA ng/mL 0.470 0.350 – 0.580 2.70 2.10 – 3.40 17.0 13.6 – 20.4
Monobind AccuBind ELISA ng/mL 0.370 0.250 – 0.500 2.55 1.71 – 3.39 >10.0
Monobind AccuLite CLIA ng/mL 0.360 0.240 – 0.470 2.74 1.83 – 3.64 >10.0
PSA (TOTAL) (2)
Beckman Coulter IRMA (IM1950) ng/mL <1.02 2.62 1.96 – 3.27 16.2 12.1 – 20.2
BioCheck EIA ng/mL § § §
Cisbio Bioassays ng/mL 0.990 0.790 – 1.19 3.90 3.10 – 4.70 19.7 15.7 – 23.7
DIALAB PSA ng/mL 0.670 0.470 – 0.860 2.57 1.73 – 3.40 14.3 10.6 – 18.1
DiaMetra ELISA ng/mL
DRG ELISA (EIA-3719) ng/mL 1.01 0.560 – 1.46 3.40 2.21 – 4.59 17.7 11.5 – 23.9
Fortress Diagnostics ng/mL
HUMAN ELISA ng/mL 1.14 0.628 – 1.66 5.22 3.39 – 7.05 24.7 16.1 – 33.3
IBL ELISA ng/mL 1.00 0.600 – 1.50 3.40 2.20 – 4.60 17.7 11.5 – 23.9
Institute of Isotopes IRMA ng/mL 1.29 0.970 – 1.61 4.40 3.50 – 5.30 25.8 20.6 – 30.9
Monobind AccuBind ELISA ng/mL <2.00 4.94 3.29 – 6.52 26.9 18.0 – 35.8
Monobind AccuLite CLIA ng/mL <2.00 4.99 3.34 – 6.63 26.4 17.7 – 35.2
SALICYLATE (2)
Cambridge Life Sciences (K9001) mg/dL 3.84 3.23 – 4.45 15.5 14.6 – 16.3 47.3 46.0 – 48.7

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SALICYLATE (2) (continued)
SEKURE (Sekisui Diagnostics) mg/dL <5.30 16.5 12.4 – 20.6 47.9 35.9 – 59.9
T3 (FREE) (2)
Beckman Coulter RIA (IM1579) pg/mL 2.34 1.75 – 2.92 8.64 6.48 – 10.8 15.8 11.9 – 19.8
BRAHMS Diagnostica RIA SPART pg/mL 2.90 2.03 – 3.77 11.6 9.74 – 13.5 24.9 20.5 – 29.4
Calbiotech ELISA pg/mL 3.04 2.02 – 4.05 5.48 3.65 – 7.30 7.51 5.01 – 10.0
Cisbio Bioassays pg/mL 2.44 1.78 – 3.10 7.10 5.60 – 8.60 12.1 9.60 – 14.6
Demeditec Diagnostics RIA/CT (DE 06100) pg/mL 3.12 2.47 – 3.77 9.29 7.40 – 11.2 16.8 13.4 – 20.2
DiaMetra ELISA pg/mL 2.47 1.73 – 3.20 4.59 3.21 – 5.96 6.42 4.50 – 8.35
EUROIMMUN RIA CT pg/mL 3.99 2.99 – 4.99 13.1 9.81 – 16.3 25.2 18.9 – >27.5
Fortress Diagnostics pg/mL
HUMAN ELISA pg/mL 2.65 1.77 – 3.52 5.36 3.59 – 7.12 7.64 5.12 – 10.2
IBL ELISA pg/mL 2.47 1.73 – 3.21 4.59 3.21 – 5.96 6.42 4.50 – 8.35
Monobind AccuBind ELISA pg/mL 2.65 1.77 – 3.52 5.36 3.59 – 7.12 7.64 5.12 – 10.2
Monobind AccuLite CLIA pg/mL 2.54 1.70 – 3.38 5.14 3.44 – 6.84 7.34 4.92 – 9.76
MP BioMedicals SPCS RIA pg/mL
T3 (TOTAL) (2)
Beckman Coulter RIA (IM1699) ng/dL 76.6 53.9 – 99.4 168 126 – 210 251 189 – 314
BioCheck EIA ng/mL § § §
BRAHMS Diagnostica RIA ng/dL 76.6 53.9 – 99.4 168 126 – 210 251 189 – 314
Calbiotech ELISA ng/dL 88.0 58.0 – 117 206 137 – 275 332 218 – 445
Cisbio Bioassays ng/mL 0.530 0.420 – 0.640 1.29 1.03 – 1.55 2.22 1.77 – 2.67
DIALAB T3 ng/mL 0.980 0.500 – 1.47 2.04 1.49 – 2.58 2.90 2.11 – 3.70
DiaMetra ELISA ng/mL
DIAsource RIA CT ng/dL 46.2 34.0 – 58.5 118 105 – 131 191 166 – 215
DRG ELISA (EIA-4569) ng/dL 101 56.0 – 147 197 108 – 285 312 171 – 452
Fortress Diagnostics ng/mL
HUMAN ELISA ng/dL 113 73.0 – 154 248 166 – 329 366 245 – 486
Institute of Isotopes IRMA ng/dL 97.4 73.4 – 122 182 143 – 214 253 201 – 299
Monobind AccuBind ELISA ng/mL 1.13 0.730 – 1.54 2.48 1.66 – 3.29 3.66 2.45 – 4.86
Monobind AccuLite CLIA ng/mL 1.01 0.680 – 1.34 2.33 1.56 – 3.10 3.55 2.38 – 4.72
MP BioMedicals SPCS RIA ng/dL
T3 UPTAKE/T UPTAKE (2)
Beckman Coulter RIA (A30282) % Uptake 35.1 26.3 – 43.9 39.4 29.6 – 49.3 41.4 31.0 – 51.7
CEDIA % Uptake
DRI % Uptake
Monobind AccuBind ELISA % Uptake 29.5 27.0 – 32.0 35.8 33.3 – 38.2 41.7 39.2 – 44.1
Monobind AccuLite CLIA % Uptake 29.8 26.7 – 32.9 35.9 32.9 – 39.0 40.0 36.1 – 43.9
MP BioMedicals SPCS RIA % Uptake
T4 (FREE) (2)
Beckman Coulter RIA (IM1363) pg/mL 10.0 7.98 – 12.0 20.6 15.5 – 25.8 31.2 23.5 – 39.1
BRAHMS Diagnostica RIA pg/mL 10.1 7.75 – 12.4 27.9 23.3 – 32.6 48.1 39.5 – 56.6
Calbiotech ELISA ng/dL 1.22 0.810 – 1.63 3.42 2.28 – 4.56 4.33 2.89 – 5.77
Cisbio Bioassays pg/mL 9.20 6.70 – 11.7 30.0 24.0 – 36.0 38.0 30.0 – 46.0
Demeditec Diagnostics RIA/CT (DE 07100) ng/dL 0.930 0.744 – 1.12 2.29 1.83 – 2.74 3.47 2.78 – 4.17
DIALAB FT4 ng/dL 1.24 0.480 – 2.00 2.52 1.81 – 3.23 3.39 2.66 – 4.12
DiaMetra ELISA ng/dL 0.830 0.580 – 1.08 2.19 1.53 – 2.84 3.06 2.14 – 3.98
EUROIMMUN RIA CT ng/dL 1.39 1.04 – 1.74 3.22 2.42 – 4.03 4.58 3.43 – 5.73
Fortress Diagnostics ng/dL
HUMAN ELISA ng/dL 0.820 0.550 – 1.09 2.33 1.56 – 3.10 3.21 2.15 – >4.00
IBL ELISA ng/dL 0.830 0.580 – 1.08 2.19 1.53 – 2.84 3.06 2.14 – 3.98
Institute of Isotopes (RIA) ng/dL 1.30 0.972 – 1.62 3.24 2.59 – 3.89 4.68 3.74 – 5.62
Monobind AccuBind ELISA ng/dL 0.820 0.550 – 1.09 2.33 1.56 – 3.10 3.21 2.15 – 4.27
Monobind AccuLite CLIA ng/dL 0.890 0.590 – 1.18 2.22 1.49 – 2.95 3.02 2.02 – 4.02
MP BioMedicals SPCS RIA ng/dL

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
T4 (TOTAL) (2)
Beckman Coulter RIA (IM1447) µg/dL 4.56 3.42 – 5.70 8.68 6.49 – 10.9 9.46 7.08 – 11.8
BioCheck EIA µg/dL § § §
BRAHMS Diagnostica RIA µg/dL 4.56 3.42 – 5.70 8.68 6.49 – 10.9 9.46 7.08 – 11.8
Calbiotech ELISA µg/dL 5.41 3.58 – 7.25 9.91 6.61 – 13.2 11.5 7.64 – 15.3
CEDIA µg/dL
Cisbio Bioassays ng/mL 52.0 41.0 – 63.0 106 84.0 – 128 122 97.0 – 147
DIALAB T4 µg/dL 2.90 2.13 – 3.67 5.37 4.47 – 6.28 8.50 5.45 – 11.6
DiaMetra ELISA µg/dL 5.42 3.80 – 7.05 9.76 6.83 – 12.7 11.4 8.00 – 14.9
DIAsource RIA CT µg/dL 4.66 3.72 – 5.60 7.60 6.67 – 8.60 8.68 6.05 – 11.3
DRG ELISA (EIA-4568) µg/dL 4.57 2.51 – 6.62 9.46 5.19 – 13.6 11.9 6.54 – 17.3
DRI µg/dL
Fortress Diagnostics µg/dL
HUMAN ELISA µg/dL 5.52 3.70 – 7.34 10.8 7.23 – 14.4 14.1 9.47 – 18.8
Institute of Isotopes IRMA µg/dL 4.57 3.43 – 5.71 8.76 7.01 – 10.5 9.64 7.71 – 11.6
Monobind AccuBind ELISA µg/dL 5.52 3.70 – 7.34 10.8 7.23 – 14.4 14.1 9.47 – 18.8
Monobind AccuLite CLIA µg/dL 6.15 4.12 – 8.18 10.1 6.73 – 13.4 12.8 8.54 – 17.0
MP BioMedicals SPCS RIA µg/dL
TESTOSTERONE (2)
Beckman Coulter RIA Direct (IM1119) ng/mL 1.02 0.670 – 1.38 2.80 1.82 – 3.79 6.33 4.12 – 8.55
Beckman Coulter RIA Extraction (IM1087) ng/mL 1.59 0.960 – 2.23 3.98 2.59 – 5.37 8.12 5.28 – 11.0
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 2.00 1.34 – 2.68 5.42 3.61 – 7.22 12.6 8.42 – 16.8
Cisbio Bioassays ng/mL 1.18 0.922 – 1.44 3.57 2.85 – 4.29 8.36 6.63 – 10.1
DIALAB Testosterone ng/mL 0.730 0.420 – 1.03 3.99 2.03 – 5.95 10.7 7.55 – 13.8
DiaMetra ELISA ng/mL 0.790 0.550 – 1.02 3.63 2.54 – 4.71 9.87 6.91 – 12.8
DIAsource RIA CT ng/mL 0.390 0.274 – 0.509 2.06 1.63 – 2.48 4.20 3.18 – 5.23
DRG ELISA (EIA-1559) ng/mL 1.69 0.980 – 2.40 5.17 3.00 – 7.37 13.5 7.84 – 19.2
HUMAN ELISA ng/mL 1.69 0.980 – 2.40 5.17 3.00 – 7.37 13.5 7.84 – 19.2
IBL ELISA ng/mL 1.17 0.930 – 1.40 3.10 2.48 – 3.72 7.55 6.04 – 9.07
Monobind AccuBind ELISA ng/mL 0.930 0.620 – 1.24 3.45 2.31 – 4.58 7.96 5.33 – 10.6
Monobind AccuLite CLIA ng/mL 1.00 0.670 – 1.33 3.98 2.66 – 5.29 9.22 6.18 – >12.0
MP BioMedicals ImmuChem DA RIA ng/mL
ZenTech RiAZEN ng/mL § § §
TESTOSTERONE (FREE) (2)
Beckman Coulter RIA (DSL4900) pg/mL 2.88 1.73 – 4.03 11.0 7.71 – 14.3 28.5 20.0 – 37.1
Calbiotech ELISA pg/mL 3.44 2.29 – 4.58 15.5 10.3 – 20.6 26.3 17.5 – 35.0
DiaMetra ELISA pg/mL 2.31 1.62 – 3.00 10.9 7.60 – 14.1 30.3 21.2 – 39.3
DIAsource RIA CT pg/mL 2.08 1.46 – 2.70 6.08 4.17 – 8.00 17.2 12.1 – 22.3
IBL ELISA pg/mL 3.07 1.69 – 4.45 12.4 6.80 – 17.9 36.2 19.9 – 52.5
IBL ELISA (Gen. II) pg/mL 2.30 1.60 – 3.00 10.9 7.60 – 14.1 30.3 21.2 – 39.3
Monobind AccuBind ELISA pg/mL 2.56 1.71 – 3.40 11.3 7.58 – 15.1 30.2 11.6 – 48.9
Monobind AccuLite CLIA pg/mL 2.57 1.72 – 3.42 12.7 7.13 – 18.3 39.7 23.5 – 55.9
THEOPHYLLINE (2)
CEDIA II µg/mL
Sekisui Medical Nanopia µg/mL 4.25 2.55 – 5.95 14.8 10.3 – 19.2 30.5 24.4 – 36.6
THYROID STIMULATING HORMONE (TSH) (2)
Beckman Coulter IRMA (IM3712) µIU/mL 0.450 0.320 – 0.590 5.87 4.40 – 7.33 39.3 29.5 – 49.1
BioCheck EIA µIU/mL § § §
BRAHMS Diagnostica LIA µIU/mL § § §
BRAHMS Diagnostica RIA µIU/mL 0.690 0.570 – 0.810 7.30 6.30 – 8.30 51.0 44.0 – 58.0
Calbiotech ELISA µIU/mL <0.500 2.87 1.91 – 3.83 28.6 19.1 – 38.1
Cisbio Bioassays µIU/mL 0.540 0.430 – 0.650 6.40 5.10 – 7.70 42.0 33.0 – 51.0
Demeditec TSH1h µIU/mL 0.400 0.300 – 0.500 5.20 4.20 – 6.20 37.2 29.8 – 44.6
DIALAB TSH µIU/mL 0.400 0.060 – 0.750 3.40 2.99 – 3.85 >15.0
DiaMetra ELISA µIU/mL 0.270 <0.200 – 0.350 3.67 2.57 – 4.77 >20.0

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
THYROID STIMULATING HORMONE (TSH) (2) (continued)
DIAsource IRMA µIU/mL 0.558 0.429 – 0.687 5.70 5.19 – 6.20 39.4 35.9 – 42.9
DRG ELISA (EIA-4171) µIU/mL 0.300 0.160 – 0.430 3.88 2.52 – 5.23 >15.0
EUROIMMUN IRMA CT µIU/mL 0.560 0.420 – 0.700 5.98 4.49 – 7.47 38.6 28.9 – 48.3
Fortress Diagnostics µIU/mL
HUMAN ELISA µIU/mL 0.213 0.117 – 0.308 4.53 2.95 – 6.12 34.7 22.6 – 46.9
IBL ELISA µIU/mL 0.300 0.160 – 0.430 3.90 2.50 – 5.20 >15.0
IBL RIA µIU/mL § § §
Institute of Isotopes IRMA (Turbo-hTSH) µIU/mL 0.470 0.350 – 0.580 5.70 4.50 – 6.80 38.6 30.9 – 46.3
Monobind AccuBind ELISA µIU/mL 0.530 0.350 – 0.700 5.87 3.94 – 7.81 39.6 26.5 – >40.0
Monobind AccuLite CLIA µIU/mL 0.430 0.290 – 0.580 5.44 3.64 – 7.23 37.0 24.8 – >40.0
MP BioMedicals ImmuChem CT IRMA µIU/mL
THYROXINE BINDING GLOBULIN (TBG) (2)
BRAHMS Diagnostica RIA µg/mL 14.6 12.9 – 16.3 12.8 11.3 – 14.3 11.6 10.4 – 12.8
TOBRAMYCIN (2)
CEDIA µg/mL
VALPROIC ACID (2)
CEDIA II µg/mL
Sekisui Medical Nanopia µg/mL 34.5 20.7 – 48.3 86.2 60.3 – 112 128 102 – >150
VANCOMYCIN (2)
Sekisui Medical Nanopia µg/mL 11.6 6.96 – 16.2 19.4 13.6 – 25.2 35.1 28.1 – 42.1
VITAMIN B12 (2)
Monobind AccuBind ELISA pg/mL 409 274 – 544 649 435 – 863 826 554 – 1099
Monobind AccuLite CLIA pg/mL 375 251 – 498 637 427 – 848 807 541 – 1073
MP BioMedicals SimulTRAC SNB RIA pg/mL
MP BioMedicals SimulTRAC SP RIA pg/mL

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen (MULTIGENT) µg/mL 10.8 8.78 – 12.7 36.8 31.8 – 41.8 107 93.8 – 120
Carbamazepine (5P05-21) µg/mL <1.90 – 2.95 6.56 4.83 – 8.28 11.4 9.08 – 13.7
Digoxin (MULTIGENT) ng/mL 0.753 0.530 – 0.975 1.91 1.49 – 2.34 3.24 2.58 – 3.89
Gentamicin (MULTIGENT) µg/mL 2.49 1.89 – 3.10 4.87 3.96 – 5.79 7.83 6.51 – 9.15
Immunoglobulin A (IgA) mg/dL 164 140 – 188 146 126 – 166 139 121 – 158
Immunoglobulin E (IgE) (MULTIGENT) IU/mL 328 265 – 391 73.1 60.0 – 86.2 94.3 77.0 – 112
Immunoglobulin G (IgG) mg/dL 844 680 – 1008 788 635 – 941 734 591 – 877
Immunoglobulin M (IgM) mg/dL 61.8 50.1 – 73.4 69.1 56.8 – 81.4 59.9 48.4 – 71.4
Iron µg/dL 132 117 – 147 80.0 70.8 – 89.2 68.7 60.2 – 77.2
Lithium (MULTIGENT) mEq/L 0.466 0.361 – 0.570 1.23 1.06 – 1.41 1.83 1.60 – 2.07
Phenobarbital (5P07-21) µg/mL § § §
Phenytoin (5P08-21) µg/mL 7.13 5.22 – 9.04 14.3 9.87 – 18.7 27.7 20.0 – 35.5
Salicylate (MULTIGENT) mg/dL <5.00 15.3 13.2 – 17.3 46.1 41.8 – 50.4
Theophylline (5P06-21) µg/mL 4.74 3.80 – 5.67 14.6 12.2 – 17.1 30.3 25.0 – 35.7
Tobramycin (MULTIGENT) µg/mL 0.600 0.316 – 0.884 2.65 2.10 – 3.20 5.22 4.34 – 6.10
Valproic Acid (MULTIGENT) µg/mL 32.9 26.7 – 39.1 74.6 64.9 – 84.4 119 106 – 132
Vancomycin (MULTIGENT) µg/mL 9.63 6.42 – 12.9 18.7 12.0 – 25.3 34.1 21.5 – 46.7
ABBOTT ARCHITECT iSYSTEMS
AFP ng/mL 16.6 12.4 – 20.8 91.3 67.0 – 116 198 142 – 255
Carbamazepine (1P36-25) µg/mL 3.02 2.49 – 3.55 7.83 6.61 – 9.04 13.9 11.8 – 16.0
Carbamazepine (1P36-27) µg/mL 3.02 2.49 – 3.55 7.83 6.61 – 9.04 13.9 11.8 – >15.0
CEA ng/mL 2.35 1.66 – 3.04 18.4 14.9 – 22.0 41.7 34.0 – 49.5
Cortisol µg/dL 3.87 2.83 – 4.90 14.5 11.3 – 17.7 25.9 20.4 – 31.3
C-Peptide ng/mL 0.991 0.615 – 1.37 4.95 3.35 – 6.54 8.13 5.55 – 10.7
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 78.6 65.0 – 92.3 159 134 – 185 595 507 – 683
Digoxin ng/mL 0.533 0.392 – 0.673 1.65 1.40 – 1.91 2.98 2.59 – 3.38
Estradiol pg/mL 84.3 55.2 – 113 167 122 – 212 345 265 – 425
Ferritin ng/mL 75.2 58.5 – 92.0 184 138 – 230 472 348 – 597
Folate ng/mL 4.89 3.08 – 6.69 11.7 8.42 – 14.9 >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 5.51 4.55 – 6.47 20.7 17.2 – 24.2 43.2 35.9 – 50.4
Gentamicin µg/mL 2.25 1.89 – 2.62 4.49 3.66 – 5.32 8.55 6.87 – >10.0
hCG mIU/mL 5.32 3.07 – 7.58 21.5 16.5 – 26.4 159 131 – 187
Insulin µIU/mL 14.3 12.0 – 16.6 48.4 41.9 – 54.9 146 128 – 165
Luteinizing Hormone (LH) mIU/mL 1.04 0.806 – 1.28 14.2 11.0 – 17.5 49.7 38.3 – 61.1
Phenobarbital µg/mL 9.92 8.10 – 11.7 25.1 20.8 – 29.3 48.7 40.7 – 56.7
Phenytoin µg/mL 6.28 5.23 – 7.32 13.1 11.1 – 15.1 23.8 20.2 – 27.3
Progesterone ng/mL 0.758 0.541 – 0.975 8.76 6.40 – 11.1 26.0 18.6 – 33.3
Prolactin ng/mL 7.41 5.94 – 8.87 22.0 17.9 – 26.2 46.9 38.2 – 55.6
PSA (Free) ng/mL 0.244 0.184 – 0.303 1.77 1.43 – 2.11 12.2 9.51 – 15.0
PSA (Total) ng/mL 0.819 0.648 – 0.990 3.02 2.39 – 3.65 18.5 14.6 – 22.3
T3 (Free) pg/mL 2.11 1.50 – 2.72 5.73 4.39 – 7.08 10.3 8.03 – 12.6
T3 (Free) (7K63-02) pg/mL 2.28 1.64 – 2.92 6.24 4.79 – 7.68 10.5 8.22 – 12.9
T3 (Total) ng/mL 0.751 0.549 – 0.953 1.68 1.35 – 2.02 2.63 2.16 – 3.10
T3 Uptake/T Uptake T Uptake Unit 0.925 0.773 – 1.08 0.822 0.679 – 0.965 0.782 0.643 – 0.922
T4 (Free) ng/dL 0.827 0.680 – 0.973 2.08 1.55 – 2.60 3.16 2.26 – 4.05
T4 (Total) µg/dL 4.99 3.88 – 6.10 10.2 7.61 – 12.7 11.8 8.76 – 14.8
Testosterone ng/dL 168 112 – 224 391 295 – 487 837 662 – 1013
Theophylline µg/mL 4.08 3.22 – 4.93 12.6 10.1 – 15.2 24.2 19.3 – 29.0
Thyroid Stimulating Hormone (TSH) µIU/mL 0.372 0.237 – 0.506 4.18 3.45 – 4.91 28.4 23.7 – 33.2
Valproic Acid µg/mL 30.1 23.5 – 36.7 72.6 58.6 – 86.5 114 92.7 – 135
Vancomycin (1P30-27) µg/mL 12.1 10.0 – 14.2 19.9 16.3 – 23.5 35.9 29.3 – 42.6
Vancomycin (1P30-28) µg/mL 12.1 10.0 – 14.2 19.9 16.3 – 23.5 35.9 29.3 – 42.6
Vitamin B12 pg/mL 381 254 – 508 625 437 – 812 769 546 – 992
BECKMAN COULTER ACCESS / 2 / 2i
AFP ng/mL 20.2 14.8 – 25.6 104 77.0 – 130 227 169 – 285

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
BECKMAN COULTER ACCESS / 2 / 2i (continued)
CEA (CEA2) ng/mL 1.90 1.41 – 2.39 17.1 13.7 – 20.5 45.9 37.1 – 54.8
Cortisol µg/dL 3.52 2.41 – 4.63 15.2 11.8 – 18.6 29.0 22.8 – 35.1
C-Peptide (2) ng/mL 0.790 0.630 – 0.950 3.95 3.16 – 4.74 6.49 5.19 – 7.78
Digoxin ng/mL 0.778 0.520 – 1.04 2.02 1.54 – 2.50 3.42 2.74 – 4.10
Estradiol pg/mL 101 63.9 – 137 269 183 – 355 649 451 – 847
Estradiol (Sensitive) pg/mL § § §
Estriol (Free) (Unconjugated Estriol) ng/mL 1.38 0.969 – 1.79 3.83 3.01 – 4.66 >6.90
Ferritin ng/mL 49.9 38.5 – 61.4 116 89.4 – 143 278 214 – 342
Folate (FOLW) ng/mL 4.12 2.88 – 5.37 9.25 6.64 – 11.8 17.2 12.7 – 21.8
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.96 5.30 – 8.62 23.7 18.2 – 29.3 40.2 30.7 – 49.6
hCG (Total ßhCG) (5th IS) mIU/mL 6.29 4.84 – 7.74 25.2 20.6 – 29.7 174 147 – 201
Insulin (Ultrasensitive Insulin) µIU/mL 15.1 12.0 – 18.1 51.4 42.1 – 60.8 156 128 – 183
Luteinizing Hormone (LH) (hLH) mIU/mL 1.18 0.857 – 1.49 16.7 13.0 – 20.3 60.4 47.6 – 73.2
Progesterone ng/mL 0.887 0.572 – 1.20 10.2 7.11 – 13.3 27.7 20.2 – 35.2
Progesterone (P4DE) ng/mL 0.550 0.340 – 0.760 8.04 5.41 – 10.8 24.1 17.1 – 31.4
Prolactin ng/mL 5.85 4.75 – 6.95 16.7 13.8 – 19.7 34.2 28.4 – 40.1
PSA (Free) (Hybritech free PSA) ng/mL 0.375 0.263 – 0.487 2.39 1.96 – 2.82 14.9 12.3 – 17.5
PSA (Free) (WHO 96/668) ng/mL 0.295 0.207 – 0.383 1.94 1.54 – 2.29 11.8 9.72 – 13.8
PSA (Total) (Hybritech PSA) ng/mL 1.02 0.851 – 1.19 3.80 3.17 – 4.42 23.1 19.3 – 26.9
PSA (Total) (WHO 96/670) ng/mL 0.862 0.719 – 1.01 2.96 2.47 – 3.44 18.0 15.0 – 21.0
T3 (Free) (Free T3) (2) pg/mL 2.35 1.87 – 2.83 5.37 4.29 – 6.45 8.71 6.97 – 10.5
T3 (Total) (Total T3) ng/mL 0.830 0.575 – 1.08 1.81 1.39 – 2.23 2.96 2.35 – 3.56
T3 Uptake/T Uptake % Uptake 42.6 34.5 – 50.7 49.5 40.2 – 58.7 55.7 45.8 – 65.5
T4 (Free) (Free T4) ng/dL 0.758 0.601 – 0.915 2.18 1.76 – 2.61 3.27 2.63 – 3.91
T4 (Total) (Total T4) µg/dL 5.60 4.03 – 7.17 10.5 8.09 – 12.9 12.7 9.91 – 15.5
Testosterone ng/mL 1.22 0.936 – 1.49 3.64 2.90 – 4.38 8.83 7.10 – 10.6
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.397 0.315 – 0.479 4.84 3.72 – 5.96 33.1 25.4 – 40.8
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.399 0.316 – 0.482 4.72 3.63 – 5.82 32.2 24.7 – 39.7
Vitamin B12 pg/mL 259 190 – 327 468 346 – 589 623 443 – 802
BECKMAN COULTER AU SYSTEMS
Acetaminophen µg/mL 11.2 <10.0 – 14.6 36.3 27.3 – 45.4 102 78.5 – 126
Acetaminophen (Enzymatic Paracetamol, Europe) (2) µg/mL § § §
Carbamazepine µg/mL 2.88 <2.00 – 3.91 7.52 5.68 – 9.35 13.5 10.6 – 16.4
Digoxin ng/mL 0.696 <0.200 – 1.29 1.87 1.09 – 2.65 3.23 2.23 – 4.23
Digoxin (Europe) ng/mL 0.906 0.510 – 1.30 2.25 1.71 – 2.79 3.77 3.15 – 4.39
Ferritin ng/mL 65.2 50.5 – 79.8 119 92.3 – 146 267 207 – 327
Gentamicin µg/mL 2.35 1.78 – 2.92 4.72 3.40 – 6.04 7.85 5.62 – 10.1
Immunoglobulin A (IgA) mg/dL 168 144 – 191 149 127 – 172 143 120 – 165
Immunoglobulin E (IgE) (Biomed) IU/mL 321 237 – 405 70.2 52.2 – 88.3 93.6 70.6 – 117
Immunoglobulin G (IgG) mg/dL 784 665 – 903 740 629 – 851 690 588 – 792
Immunoglobulin M (IgM) mg/dL 58.9 45.0 – 72.8 66.0 50.8 – 81.2 58.0 44.3 – 71.7
Lithium mEq/L 0.500 0.340 – 0.660 1.20 0.988 – 1.41 1.80 1.54 – 2.06
Phenobarbital µg/mL 9.03 6.38 – 11.7 23.8 18.2 – 29.4 46.2 35.9 – 56.5
Phenytoin µg/mL 6.42 4.61 – 8.23 13.3 9.17 – 17.5 24.5 16.5 – 32.4
Salicylate mg/dL 4.35 2.20 – 6.50 15.5 11.3 – 19.8 44.6 34.8 – 54.3
T4 (Total) (DRI) µg/dL 6.72 5.22 – 8.22 11.9 8.91 – 14.9 13.1 9.73 – 16.4
Theophylline µg/mL 4.45 2.93 – 5.97 14.1 11.3 – 16.8 27.9 23.4 – 32.4
Tobramycin µg/mL 0.967 0.639 – 1.29 3.04 2.44 – 3.63 6.31 5.34 – 7.28
Valproic Acid µg/mL 36.7 27.1 – 46.3 81.5 64.2 – 98.8 119 95.2 – 143
Vancomycin µg/mL 8.99 6.41 – 11.6 15.0 9.74 – 20.2 27.2 16.4 – 38.0
BECKMAN COULTER SYNCHRON / UniCel DxC SERIES
Acetaminophen µg/mL 12.5 <10.0 – 19.0 42.8 32.3 – 53.3 118 97.9 – 139
Carbamazepine µg/mL 2.42 <2.00 – 3.06 7.08 5.71 – 8.46 13.1 10.7 – 15.4
Digoxin ng/mL 0.660 0.422 – 0.898 1.91 1.45 – 2.36 3.23 2.55 – 3.91
Gentamicin µg/mL 2.65 1.78 – 3.52 5.68 4.57 – 6.78 9.50 8.09 – 10.9

Page 13 English • 2020-03 • 1536-00

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
BECKMAN COULTER SYNCHRON / UniCel DxC SERIES (continued)
Immunoglobulin A (IgA) mg/dL 157 132 – 183 140 117 – 163 133 110 – 155
Immunoglobulin G (IgG) mg/dL 804 647 – 960 757 609 – 905 707 568 – 846
Immunoglobulin M (IgM) mg/dL 61.6 51.5 – 71.7 70.6 59.6 – 81.6 59.9 50.0 – 69.8
Iron µg/dL 131 111 – 151 78.8 62.4 – 95.2 68.4 52.8 – 84.0
Lithium (Infinity) mEq/L 0.423 0.268 – 0.578 1.22 1.01 – 1.44 1.84 1.58 – 2.10
Phenobarbital µg/mL 9.17 7.08 – 11.3 24.8 19.7 – 30.0 46.4 37.0 – 55.8
Phenytoin µg/mL 6.50 5.43 – 7.57 13.4 11.2 – 15.5 23.4 19.8 – 27.1
Salicylate mg/dL <4.00 – 5.78 16.2 13.6 – 18.9 48.5 43.1 – 53.9
Theophylline µg/mL 4.28 3.50 – 5.07 13.4 11.4 – 15.3 26.0 22.3 – 29.6
Tobramycin µg/mL 0.933 <0.500 – 1.39 3.88 3.22 – 4.55 7.57 6.63 – 8.50
Valproic Acid µg/mL 17.1 <10.0 – 29.2 75.4 59.0 – 91.7 115 96.3 – 134
Vancomycin µg/mL 9.78 7.10 – 12.5 17.0 13.3 – 20.7 35.2 28.9 – >40.0
BECKMAN COULTER UniCel DxI
AFP ng/mL 15.9 10.4 – 21.4 82.5 60.3 – 105 181 132 – 229
CEA (CEA2) ng/mL 1.80 1.30 – 2.31 16.5 12.4 – 20.5 44.8 33.8 – 55.8
Cortisol µg/dL 3.37 2.18 – 4.56 15.1 11.4 – 18.8 28.9 22.2 – 35.6
C-Peptide (2) ng/mL 0.760 0.610 – 0.910 3.60 2.88 – 4.32 5.90 4.72 – 7.08
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 60.9 46.2 – 75.6 129 98.6 – 160 447 341 – 552
Digoxin ng/mL 0.778 0.520 – 1.04 2.02 1.54 – 2.50 3.42 2.74 – 4.10
Estradiol pg/mL 92.8 63.7 – 122 216 165 – 267 491 391 – 590
Estradiol (Sensitive) pg/mL 91.4 62.2 – 121 175 130 – 220 410 321 – 499
Estriol (Free) (Unconjugated Estriol) ng/mL 1.38 0.969 – 1.79 3.83 3.01 – 4.66 >6.90
Ferritin ng/mL 52.4 40.0 – 64.7 117 88.0 – 145 281 211 – 352
Folate (FOLW) ng/mL 4.09 2.82 – 5.36 9.63 6.95 – 12.3 18.4 14.0 – 22.9
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.96 5.30 – 8.62 23.7 18.2 – 29.3 40.2 30.7 – 49.6
hCG (Total ßhCG) (5th IS) mIU/mL 6.65 5.12 – 8.17 24.4 19.7 – 29.2 177 147 – 207
Insulin (Ultrasensitive Insulin) µIU/mL 14.3 11.6 – 16.9 49.6 40.0 – 59.2 150 120 – 179
Luteinizing Hormone (LH) (hLH) mIU/mL 1.18 0.857 – 1.49 16.7 13.0 – 20.3 60.4 47.6 – 73.2
Progesterone ng/mL 0.877 0.565 – 1.19 10.6 7.39 – 13.8 28.5 21.0 – 36.0
Progesterone (P4DE) ng/mL 0.540 0.330 – 0.760 8.39 5.64 – 11.2 24.9 17.8 – 32.2
Prolactin ng/mL 5.69 4.53 – 6.86 16.3 13.2 – 19.4 34.2 27.9 – 40.5
PSA (Free) (Hybritech free PSA) ng/mL 0.336 0.210 – 0.462 2.16 1.70 – 2.61 13.6 10.8 – 16.4
PSA (Free) (WHO 96/668) ng/mL 0.264 0.165 – 0.364 1.75 1.34 – 2.12 10.7 8.53 – 13.0
PSA (Total) (Hybritech PSA) ng/mL 0.972 0.787 – 1.16 3.69 3.00 – 4.39 22.2 18.0 – 26.4
PSA (Total) (WHO 96/670) ng/mL 0.821 0.665 – 0.980 2.87 2.34 – 3.42 17.3 14.0 – 20.6
T3 (Free) (Free T3) pg/mL 2.50 1.72 – 3.29 5.10 3.35 – 6.86 7.89 5.07 – 10.7
T3 (Total) (Total T3) ng/mL 0.873 0.586 – 1.16 1.76 1.28 – 2.25 3.05 2.28 – 3.83
T3 Uptake/T Uptake % Uptake 44.8 36.5 – 53.1 51.6 42.0 – 61.2 56.1 46.3 – 65.8
T4 (Free) (Free T4) ng/dL 0.770 0.576 – 0.964 2.16 1.69 – 2.63 3.47 2.72 – 4.22
T4 (Total) (Total T4) µg/dL 4.99 3.50 – 6.47 9.87 7.54 – 12.2 12.1 9.35 – 14.8
Testosterone ng/mL 1.10 0.866 – 1.34 3.37 2.56 – 4.18 7.64 5.74 – 9.55
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.390 0.303 – 0.477 4.80 3.61 – 5.99 31.2 23.4 – 39.0
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.407 0.314 – 0.499 4.95 3.70 – 6.19 32.6 24.3 – 40.8
Vitamin B12 pg/mL 264 187 – 340 510 362 – 657 665 462 – 869
BIOMÉRIEUX VIDAS
AFP ng/mL 15.4 9.79 – 21.1 98.6 62.1 – 135 228 155 – 302
CEA (S) ng/mL 1.43 0.724 – 2.14 8.52 6.31 – 10.7 17.8 13.4 – 22.2
Cortisol (S) ng/mL 30.8 15.5 – 46.2 146 92.9 – 199 277 180 – 374
Digoxin ng/mL 0.603 0.335 – 0.872 1.89 1.34 – 2.43 3.37 2.53 – 4.20
Estradiol (II) pg/mL 124 89.7 – 159 338 265 – 410 810 666 – 955
Ferritin ng/mL 58.5 37.6 – 79.5 118 75.3 – 160 280 177 – 382
Follicle Stimulating Hormone (FSH) mIU/mL 6.69 5.37 – 8.01 23.6 18.8 – 28.3 51.0 40.6 – 61.5
hCG mIU/mL 7.66 4.88 – 10.4 27.7 19.6 – 35.7 212 155 – 269
Immunoglobulin E (IgE) (Total) IU/mL 337 212 – 463 77.0 51.8 – 102 99.8 65.8 – 134
Luteinizing Hormone (LH) mIU/mL 1.54 1.19 – 1.89 17.2 13.9 – 20.4 66.9 55.7 – 78.1

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
BIOMÉRIEUX VIDAS (continued)
Progesterone ng/mL 0.968 0.483 – 1.45 14.2 10.6 – 17.8 43.9 36.4 – 51.4
Prolactin ng/mL 6.65 4.12 – 9.18 19.3 14.1 – 24.5 39.0 29.6 – 48.4
PSA (Free) ng/mL 0.405 0.285 – 0.525 2.42 1.70 – 3.14 >10.0
PSA (Total) ng/mL 1.21 0.809 – 1.61 3.90 2.83 – 4.97 23.2 17.3 – 29.1
T3 (Free) pg/mL 2.23 1.58 – 2.88 7.40 5.46 – 9.33 13.1 9.73 – 16.4
T3 (Total) ng/mL 0.767 0.445 – 1.09 1.97 1.42 – 2.51 3.10 2.34 – 3.86
T4 (Free) (FT4N) (30459) ng/dL 0.985 0.693 – 1.28 2.88 2.07 – 3.68 4.43 3.30 – 5.56
T4 (Total) µg/dL 5.81 4.35 – 7.27 11.2 8.74 – 13.6 14.3 11.3 – 17.2
Testosterone (II) (414320) (2) ng/mL 0.900 0.650 – 1.15 3.22 2.57 – 3.88 8.42 6.77 – 10.1
Thyroid Stimulating Hormone (TSH) µIU/mL 0.413 0.197 – 0.630 5.64 4.45 – 6.83 37.9 30.5 – 45.2
Thyroid Stimulating Hormone (TSH) (TSH3) µIU/mL 0.322 0.106 – 0.539 4.72 3.70 – 5.73 32.1 25.9 – 38.4
DIASORIN LIAISON (2)
ACTH (5) pg/mL 20.3 2.86 – 37.7 193 122 – 264 193 144 – 242
AFP IU/mL 15.6 12.3 – 18.9 81.3 66.7 – 95.9 180 139 – 221
Aldosterone ng/dL 12.1 8.47 – 15.7 26.1 18.3 – 34.0 67.0 46.9 – 87.1
Androstenedione ng/mL 0.910 0.580 – 1.23 1.69 1.08 – 2.29 2.65 1.70 – 3.60
Calcitonin pg/mL 27.2 19.1 – 35.4 181 126 – 235 313 219 – 406
CEA ng/mL 2.06 1.06 – 3.05 15.1 10.7 – 19.5 46.4 37.0 – 55.8
Cortisol µg/dL 3.22 2.07 – 4.38 18.0 13.1 – 22.9 40.0 24.6 – 55.4
C-Peptide ng/mL 1.27 0.967 – 1.58 6.10 4.88 – 7.32 8.89 7.12 – 10.7
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 61.7 43.2 – 80.3 126 88.2 – 164 497 266 – 728
Estradiol (II Gen) (310680) pg/mL 91.5 61.3 – 122 167 117 – 218 338 237 – 440
Ferritin ng/mL 64.8 55.1 – 74.5 146 124 – 168 358 309 – 407
Follicle Stimulating Hormone (FSH) mIU/mL 7.72 6.19 – 9.25 29.7 25.2 – 34.1 70.2 59.7 – 80.8
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 6.45 4.44 – 8.46 23.9 17.2 – 30.6 54.7 42.6 – 66.8
hCG (XL hCG) (REF 312321) mIU/mL 6.20 3.76 – 8.63 25.1 21.3 – 28.8 151 113 – 189
Human Growth Hormone (hGH) ng/mL 2.78 1.94 – 3.61 7.12 4.98 – 9.26 13.9 9.74 – 18.1
Insulin µIU/mL 18.8 13.1 – 24.4 61.4 43.0 – 79.9 192 134 – 250
Luteinizing Hormone (LH) mIU/mL 1.54 1.27 – 1.81 24.1 20.1 – 28.1 107 88.4 – 125
Luteinizing Hormone (LH) (US only) mIU/mL 1.54 1.27 – 1.81 24.1 20.1 – 28.1 107 88.4 – 125
Progesterone (II Gen) (310690) ng/mL 0.930 0.370 – 1.49 10.2 6.81 – 13.5 26.3 17.6 – 34.9
Prolactin (312151) µIU/mL 163 136 – 190 487 390 – 585 1062 850 – 1274
Prolactin (xt) µIU/mL 163 136 – 190 487 390 – 585 1062 850 – 1274
PSA (Free) ng/mL 0.211 0.083 – 0.340 1.87 1.11 – 2.63 11.2 7.06 – 15.3
PSA (Total) ng/mL 0.718 0.413 – 1.02 2.66 1.84 – 3.48 18.2 12.5 – 24.0
T3 (Free) pg/mL 2.21 1.76 – 2.65 8.52 7.24 – 9.80 19.0 16.1 – 21.9
T3 (Total) ng/dL 73.3 57.5 – 89.1 166 139 – 193 280 207 – 352
T4 (Free) ng/dL 0.930 0.780 – 1.08 3.21 2.72 – 3.70 5.55 4.18 – 6.92
T4 (Free) (US only) ng/dL 0.930 0.780 – 1.08 3.21 2.72 – 3.70 5.55 4.18 – 6.92
T4 (Total) µg/dL 4.20 3.09 – 5.31 7.19 5.63 – 8.74 7.92 6.28 – 9.56
Testosterone ng/mL 0.620 0.390 – 0.840 2.07 1.45 – 2.69 4.45 3.11 – 5.78
Thyroid Stimulating Hormone (TSH) µIU/mL 0.510 0.380 – 0.640 5.66 3.78 – 7.54 38.6 29.5 – 47.7
DIASORIN LIAISON XL (2)
ACTH (5) pg/mL 18.3 11.4 – 25.2 184 128 – 240 195 128 – 261
AFP IU/mL 16.1 13.6 – 18.7 84.0 68.7 – 99.3 187 152 – 222
Aldosterone ng/dL 11.9 8.35 – 15.5 25.6 17.9 – 33.3 67.6 47.3 – 87.9
Androstenedione ng/mL 0.810 0.520 – 1.10 1.63 1.04 – 2.21 2.52 1.62 – 3.43
Calcitonin pg/mL 29.0 20.3 – 37.7 193 135 – 251 329 230 – 428
CEA ng/mL 2.12 1.37 – 2.87 15.3 12.4 – 18.3 46.5 35.6 – 57.3
Cortisol µg/dL 2.32 1.88 – 2.75 17.2 14.3 – 20.0 41.1 34.5 – 47.7
C-Peptide ng/mL 1.38 1.10 – 1.65 6.22 4.97 – 7.46 9.46 7.57 – 11.3
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 61.7 43.2 – 80.3 126 88.2 – 164 497 266 – 728
Estradiol (II Gen) (310680) pg/mL 85.3 57.1 – 113 157 110 – 204 328 230 – 426
Ferritin ng/mL 74.1 63.0 – 85.2 165 140 – 189 380 323 – 437
Follicle Stimulating Hormone (FSH) mIU/mL 8.73 6.45 – 11.0 31.4 25.3 – 37.6 75.5 63.1 – 87.9

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
DIASORIN LIAISON XL (2) (continued)
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 7.14 5.18 – 9.10 25.9 20.3 – 31.5 59.2 46.3 – 72.1
hCG (XL hCG) (REF 312321) mIU/mL 5.72 2.93 – 8.52 25.5 19.4 – 31.5 184 156 – 211
Human Growth Hormone (hGH) ng/mL 2.78 1.94 – 3.61 7.12 4.98 – 9.26 13.9 9.74 – 18.1
Insulin µIU/mL 18.8 13.1 – 24.4 61.4 43.0 – 79.9 192 134 – 250
Luteinizing Hormone (LH) mIU/mL 1.92 1.47 – 2.37 25.2 20.1 – 30.2 109 87.3 – 131
Luteinizing Hormone (LH) (US only) mIU/mL 1.92 1.47 – 2.37 25.2 20.1 – 30.2 109 87.3 – >125
Progesterone (II Gen) (310690) ng/mL 0.890 0.360 – 1.42 9.78 6.84 – 12.7 24.9 16.7 – 33.1
Prolactin (312151) µIU/mL 158 108 – 207 475 376 – 573 1028 817 – 1240
Prolactin (xt) µIU/mL 158 108 – 207 475 376 – 573 1028 817 – 1240
PSA (Free) ng/mL 0.208 0.125 – 0.290 1.88 1.51 – 2.26 10.9 8.69 – 13.0
PSA (Total) ng/mL 0.828 0.616 – 1.04 3.07 2.55 – 3.59 21.2 17.7 – 24.8
T3 (Free) pg/mL 2.38 2.02 – 2.74 8.93 7.60 – 10.3 19.8 15.4 – 24.2
T3 (Total) ng/dL 64.4 52.4 – 76.4 137 107 – 167 243 195 – 291
T4 (Free) ng/dL 1.02 0.869 – 1.18 3.41 2.90 – 3.92 6.37 5.38 – 7.36
T4 (Free) (US only) ng/dL 1.02 0.869 – 1.18 3.41 2.90 – 3.92 6.37 5.38 – 7.36
T4 (Total) µg/dL 3.85 3.20 – 4.50 6.56 5.43 – 7.68 7.18 5.57 – 8.79
Testosterone ng/mL 0.560 0.360 – 0.760 1.87 1.31 – 2.44 3.82 2.67 – 4.96
Testosterone XT ng/dL 70.0 45.0 – 95.0 257 180 – 334 510 357 – 663
Thyroid Stimulating Hormone (TSH) µIU/mL 0.568 0.483 – 0.653 6.30 5.31 – 7.29 40.2 33.1 – 47.3
Fujirebio LUMIPULSE G Series (2)
AFP (AFP-N) ng/mL 18.7 15.0 – 22.4 99.3 79.5 – 119 209 167 – 251
CEA (CEA-N) ng/mL 2.50 2.00 – 3.00 19.9 16.0 – 23.8 53.2 42.6 – 63.8
C-Peptide (Serum, Plasma) ng/mL 1.02 0.820 – 1.22 5.25 4.20 – 6.30 8.49 6.80 – 10.2
Estradiol (E2-III) pg/mL 99.3 79.5 – 119 222 178 – 266 540 432 – 648
Ferritin (N) ng/mL 45.1 36.1 – 54.1 119 95.1 – 143 291 233 – 349
Follicle Stimulating Hormone (FSH) (Product No. 230923) mIU/mL 5.70 4.60 – 6.80 19.7 15.8 – 23.6 38.4 30.8 – 46.0
Follicle Stimulating Hormone (FSH) (Product No. 292693) mIU/mL 7.80 6.30 – 9.30 27.0 21.6 – 32.4 53.1 42.5 – 63.7
hCG (Beta) mIU/mL 4.80 3.90 – 5.70 24.0 19.2 – 28.8 162 130 – 195
Immunoglobulin E (IgE) IU/mL 319 255 – 383 88.8 71.0 – 107 111 88.4 – 133
Insulin (N) µIU/mL 16.2 13.0 – 19.4 54.2 43.4 – 65.0 164 131 – 197
Luteinizing Hormone (LH) mIU/mL 1.20 1.00 – 1.40 17.2 13.8 – 20.6 61.6 49.3 – 73.9
Progesterone (PRG-N) ng/mL 0.760 0.610 – 0.910 10.7 8.54 – 12.8 28.6 22.9 – 34.3
Prolactin ng/mL 8.90 7.20 – 10.6 25.0 20.0 – 30.0 53.0 42.4 – 63.6
PSA (Free) ng/mL 0.211 0.169 – 0.253 1.50 1.20 – 1.80 9.48 7.59 – 11.4
PSA (Total) (PSA-N) ng/mL 0.832 0.666 – 0.998 2.84 2.27 – 3.41 17.1 13.7 – 20.5
T3 (Free) (III) pg/mL 2.64 2.12 – 3.16 7.55 6.04 – 9.06 14.1 11.3 – 16.9
T3 (Total) ng/mL 0.780 0.630 – 0.930 2.02 1.62 – 2.42 3.62 2.90 – 4.34
T4 (Free) (N) ng/dL 0.820 0.660 – 0.980 2.14 1.72 – 2.56 3.27 2.62 – 3.92
T4 (Total) µg/dL 6.07 4.86 – 7.28 12.8 10.3 – 15.4 16.5 13.2 – 19.8
Testosterone ng/mL 1.31 1.05 – 1.57 4.17 3.34 – 5.00 9.90 7.92 – 11.9
Thyroid Stimulating Hormone (TSH) (TSHIII) µIU/mL 0.377 0.302 – 0.452 4.30 3.44 – 5.16 27.6 22.1 – 33.1
IDS-iSYS (2)
Human Growth Hormone (hGH) (IS-3700) ng/mL 3.08 2.25 – 3.91 8.03 6.10 – 9.96 15.4 12.2 – 18.7
KHB Polaris (2)
AFP ng/mL 17.4 13.7 – 21.0 94.8 73.1 – 116 205 158 – 251
CEA ng/mL 2.14 1.53 – 2.74 15.4 10.9 – 19.9 37.7 26.9 – 48.5
C-Peptide ng/mL 1.18 0.830 – 1.54 5.22 3.73 – 6.71 8.44 6.04 – 10.8
Estradiol pg/mL 136 94.6 – 178 267 185 – 349 546 381 – 711
Follicle Stimulating Hormone (FSH) mIU/mL 6.00 4.20 – 7.80 22.5 15.7 – 29.3 46.7 32.7 – 60.8
hCG-Beta Subunit mIU/mL 5.45 3.38 – 7.53 26.1 17.1 – 35.2 173 114 – 232
Insulin µIU/mL 17.4 13.1 – 21.6 65.6 49.3 – 82.0 205 155 – 254
Luteinizing Hormone (LH) mIU/mL 1.96 1.20 – 2.72 29.9 19.6 – 40.2 122 82.4 – 161
Progesterone ng/mL 1.12 0.750 – 1.49 8.71 6.07 – 11.4 21.7 15.1 – 28.4
Prolactin ng/mL 9.68 6.73 – 12.6 28.3 19.5 – 37.1 61.5 42.3 – 80.8
PSA (Free) ng/mL 0.274 0.200 – 0.350 1.93 1.43 – 2.44 12.4 9.14 – 15.7

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
KHB Polaris (2) (continued)
PSA (Total) ng/mL 0.940 0.700 – 1.18 3.63 2.72 – 4.54 21.3 16.0 – 26.7
T3 (Free) pg/mL 2.67 1.87 – 3.47 5.68 3.93 – 7.42 9.33 6.40 – 12.3
T3 (Total) ng/mL 1.15 0.770 – 1.53 2.14 1.50 – 2.79 2.97 2.07 – 3.87
T4 (Free) ng/dL 0.960 0.730 – 1.19 2.19 1.66 – 2.71 3.00 2.28 – 3.72
T4 (Total) ng/mL 58.5 46.7 – 70.3 109 86.9 – 130 124 99.5 – 149
Thyroid Stimulating Hormone (TSH) µIU/mL 0.503 0.380 – 0.630 5.93 4.50 – 7.36 38.7 29.4 – 48.1
KHB Unico (2)
AFP ng/mL 17.4 13.7 – 21.0 94.8 73.1 – 116 205 158 – 251
CEA ng/mL 2.14 1.53 – 2.74 15.4 10.9 – 19.9 37.7 26.9 – 48.5
C-Peptide ng/mL 1.18 0.830 – 1.54 5.22 3.73 – 6.71 8.44 6.04 – 10.8
Estradiol pg/mL 136 94.6 – 178 267 185 – 349 546 381 – 711
Follicle Stimulating Hormone (FSH) mIU/mL 6.00 4.20 – 7.80 22.5 15.7 – 29.3 46.7 32.7 – 60.8
hCG-Beta Subunit mIU/mL 5.45 3.38 – 7.53 26.1 17.1 – 35.2 173 114 – 232
Insulin µIU/mL 17.4 13.1 – 21.6 65.6 49.3 – 82.0 205 155 – 254
Luteinizing Hormone (LH) mIU/mL 1.96 1.20 – 2.72 29.9 19.6 – 40.2 122 82.4 – 161
Progesterone ng/mL 1.12 0.750 – 1.49 8.71 6.07 – 11.4 21.7 15.1 – 28.4
Prolactin ng/mL 9.68 6.73 – 12.6 28.3 19.5 – 37.1 61.5 42.3 – 80.8
PSA (Free) ng/mL 0.274 0.200 – 0.350 1.93 1.43 – 2.44 12.4 9.14 – 15.7
PSA (Total) ng/mL 0.940 0.700 – 1.18 3.63 2.72 – 4.54 21.3 16.0 – 26.6
T3 (Free) pg/mL 2.81 1.96 – 3.66 5.98 4.14 – 7.82 9.82 6.74 – 12.9
T3 (Total) ng/mL 1.15 0.770 – 1.53 2.14 1.50 – 2.79 2.97 2.07 – 3.87
T4 (Free) ng/dL 0.960 0.730 – 1.19 2.19 1.66 – 2.71 3.00 2.28 – 3.72
T4 (Total) ng/mL 58.5 46.7 – 70.3 109 86.9 – 130 124 99.5 – 149
Thyroid Stimulating Hormone (TSH) µIU/mL 0.503 0.380 – 0.630 5.93 4.50 – 7.36 38.7 29.4 – 48.1
Mindray CL Series/ Wiener Lab CLIA Series (2)
ACTH pg/mL
AFP IU/mL 13.5 9.86 – 17.1 77.2 56.4 – 98.1 170 124 – 216
Calcitonin pg/mL
CEA ng/mL 2.26 1.65 – 2.88 19.0 13.8 – 24.1 46.4 33.9 – 58.9
Cortisol µg/dL 3.56 2.49 – 4.63 15.3 10.7 – 19.8 29.8 20.8 – 38.7
C-Peptide ng/mL 0.907 0.635 – 1.18 5.36 3.75 – 6.96 8.72 6.10 – 11.3
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 73.9 51.7 – 96.1 166 117 – 216 632 442 – 821
Estradiol pg/mL 79.9 55.9 – 104 198 139 – 258 517 362 – 672
Estriol (Free) (4) ng/mL 1.39 0.973 – 1.81 4.05 2.84 – 5.27 11.5 8.07 – 15.0
Ferritin ng/mL 60.4 42.3 – 78.5 170 119 – 221 449 314 – 583
Folate ng/mL
Follicle Stimulating Hormone (FSH) mIU/mL 7.01 4.91 – 9.11 25.4 17.8 – 33.1 56.8 36.7 – 73.8
hCG (4) mIU/mL
Human Chorionic Gonadotropin (hCG2.0) mIU/mL
Insulin µIU/mL 18.7 13.7 – 23.8 65.2 47.6 – 82.8 218 159 – 277
Luteinizing Hormone (LH) (4) mIU/mL 1.65 1.15 – 2.14 21.5 15.1 – 28.0 76.6 53.6 – 99.6
Progesterone ng/mL
Prolactin ng/mL 9.98 6.48 – 13.5 25.4 16.5 – 34.2 53.5 34.8 – 72.2
PSA (Free) ng/mL 0.264 0.192 – 0.335 1.78 1.30 – 2.26 11.4 8.33 – 14.5
PSA (Total) ng/mL 0.836 0.610 – 1.06 3.28 2.39 – 4.16 20.2 14.8 – 25.7
T3 (Free) pg/mL 2.37 1.66 – 3.08 6.63 4.64 – 8.62 11.0 7.72 – 14.4
T3 (Total) ng/mL 0.673 0.471 – 0.874 1.60 1.12 – 2.08 2.49 1.74 – 3.23
T4 (Free) ng/dL 0.880 0.643 – 1.12 2.40 1.75 – 3.04 3.40 2.48 – 4.32
T4 (Total) µg/dL 5.46 3.82 – 7.10 11.3 7.90 – 14.7 13.7 9.57 – 17.8
Testosterone ng/mL 1.36 0.954 – 1.77 5.39 3.77 – 7.01 13.6 9.48 – >16.0
Thyroglobulin (Tg) ng/mL
Thyroid Stimulating Hormone (TSH) (4) µIU/mL 0.497 0.363 – 0.631 5.42 3.95 – 6.88 39.8 29.0 – 50.5
Vitamin B12 pg/mL 458 297 – 618 842 547 – 1137 1129 734 – 1525
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (ACET) µg/mL 11.6 <10.0 – 15.1 42.3 31.9 – 52.7 130 104 – 155

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
ORTHO VITROS MICROSLIDE SERIES (continued)
Carbamazepine (CRBM) µg/mL <3.00 7.10 5.51 – 8.69 12.1 9.38 – 14.9
Digoxin (DGXN) ng/mL 0.732 <0.400 – 1.21 1.88 1.38 – 2.39 3.20 2.67 – 3.73
Iron (Fe) µg/dL 135 126 – 144 74.3 62.2 – 86.3 65.0 52.5 – 77.6
Lithium (Li) mmol/L 0.738 0.542 – 0.934 1.69 1.42 – 1.95 2.48 2.17 – 2.79
Phenytoin (PHYT) µg/mL 5.95 4.45 – 7.44 12.7 10.1 – 15.2 23.6 19.6 – 27.6
Salicylate (SALI) mg/dL 4.95 4.20 – 5.69 17.9 15.6 – 20.2 37.8 32.6 – >40.0
Theophylline (THEO) µg/mL 3.69 2.16 – 5.21 14.5 11.3 – 17.7 32.0 26.1 – 38.0
ORTHO VITROS MICROTIP SERIES
Gentamicin (GENT) µg/mL 2.32 1.93 – 2.72 4.50 3.66 – 5.33 7.32 5.90 – 8.74
Tobramycin (TOBRA) µg/mL 1.04 0.829 – 1.24 3.11 2.61 – 3.60 6.56 5.56 – 7.56
Valproic Acid (VALP) µg/mL 32.8 20.6 – 45.0 77.2 58.5 – 95.9 115 90.7 – 139
Vancomycin (VANC) µg/mL 8.90 6.89 – 10.9 14.8 12.0 – 17.6 27.1 22.7 – 31.4
ORTHO VITROS MICROWELL SERIES
AFP (2) (3) IU/mL 14.3 11.4 – 17.2 78.1 62.9 – 93.3 168 131 – 205
CEA ng/mL 2.02 1.36 – 2.68 16.1 13.3 – 18.9 48.8 41.0 – 56.5
Cortisol (Cort) µg/dL 3.26 2.33 – 4.20 14.8 10.6 – 19.0 29.3 20.9 – 37.7
C-Peptide (2) ng/mL 1.03 0.775 – 1.29 5.46 4.00 – 6.92 8.40 6.16 – 10.6
Estradiol (E2) (2) pg/mL 88.6 34.1 – 143 288 182 – 394 765 483 – 1048
Ferritin (Ferr) ng/mL 49.0 35.5 – 62.4 102 75.0 – 129 250 185 – 316
Folate (Fol/RCFol) ng/mL 3.33 1.73 – 4.93 8.83 4.96 – 12.7 19.2 12.5 – >20.0
Follicle Stimulating Hormone (FSH) (2) mIU/mL 4.57 3.43 – 5.71 15.7 12.6 – 18.8 35.7 28.0 – 43.4
hCG (B-hCG) mIU/mL 8.67 6.35 – 11.0 27.9 22.3 – 33.4 206 171 – 242
Insulin (2) (3) µIU/mL 15.1 9.58 – 20.6 53.8 37.3 – 70.3 165 115 – 215
Luteinizing Hormone (LH) mIU/mL 1.02 0.541 – 1.50 19.3 16.0 – 22.5 66.5 57.2 – 75.9
Progesterone (Prog) (2) ng/mL 0.827 0.456 – 1.20 10.0 7.45 – 12.5 30.4 23.4 – 37.4
Prolactin (Prol) ng/mL 8.09 6.19 – 10.0 17.1 13.8 – 20.4 34.4 28.3 – 40.4
PSA (Free) (fPSA) (2) ng/mL 0.220 0.161 – 0.279 1.46 1.07 – 1.85 9.66 7.14 – 12.2
PSA (Total) (PSA) ng/mL 0.893 0.714 – 1.07 2.51 2.06 – 2.97 13.4 11.0 – 15.7
PSA (Total) (tPSA) (2) ng/mL 0.891 0.653 – 1.13 3.20 2.35 – 4.06 20.0 14.5 – 25.5
T3 (Free) (FT3 II) (2) pg/mL 4.51 3.37 – 5.64 14.3 10.5 – 18.1 >22.7
T3 (Free) (FT3) (2) pg/mL 4.47 3.34 – 5.59 16.2 11.8 – 20.5 >22.7
T3 (Total) (TT3) ng/mL 0.949 0.757 – 1.14 2.15 1.73 – 2.56 3.49 2.82 – 4.17
T3 Uptake/T Uptake (T3U) % Uptake 37.5 32.8 – 42.1 53.0 47.5 – 58.5 63.7 57.6 – >65.0
T4 (Free) (FT4) ng/dL 1.21 0.945 – 1.48 5.12 4.40 – 5.83 >6.98
T4 (Total) (TT4) (2) µg/dL 5.33 4.33 – 6.34 10.6 8.76 – 12.5 12.6 10.5 – 14.8
Testosterone (2) ng/dL 102 64.6 – 139 470 326 – 614 1360 974 – 1746
Thyroid Stimulating Hormone (TSH) µIU/mL 0.279 0.199 – 0.358 4.49 3.70 – 5.28 31.5 26.0 – 37.0
Vitamin B12 pg/mL 387 254 – 520 714 556 – 872 840 672 – >1000
PerkinElmer AUTODELFIA (2)
AFP (hAFP) ng/mL 18.1 14.5 – 21.7 90.4 72.3 – 108 193 154 – 231
Estriol (Free) (Unconjugated, uE3) ng/mL 2.42 1.70 – 3.17 7.49 5.19 – 9.80 >14.4
Estriol (Free) (Unconjugated, uE3)(B095-101) ng/mL 2.62 1.84 – 3.46 5.76 4.03 – 7.49 11.2 8.93 – 13.5
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 5.70 4.60 – 6.80 21.0 17.0 – 25.0 44.0 35.0 – 53.0
hCG mIU/mL 8.90 6.20 – 12.0 25.0 19.0 – 31.0 207 166 – 248
Luteinizing Hormone (LH) (hLH) mIU/mL 1.30 1.00 – 1.60 18.0 14.0 – 22.0 63.0 50.0 – 76.0
Prolactin ng/mL 4.60 3.50 – 5.80 13.0 10.0 – 16.0 28.0 22.0 – 34.0
PSA (Free) (ProStatus) ng/mL § § §
PSA (Total) (ProStatus) ng/mL § § §
T3 (Total) ng/mL 1.50 0.830 – 2.20 3.20 2.60 – 3.80 4.80 3.80 – 5.80
T4 (Free) ng/dL 1.16 0.845 – 1.55 4.57 3.64 – 5.50 >6.20
T4 (Total) µg/dL 5.58 3.88 – 7.29 9.92 7.91 – 11.9 10.7 8.53 – 12.9
Thyroid Stimulating Hormone (TSH) (hTSH Ultra) µIU/mL 0.440 0.350 – 0.530 4.80 3.80 – 5.80 36.0 29.0 – 43.0
PerkinElmer DELFIA Xpress (2)
AFP (hAFP) ng/mL 18.1 14.5 – 21.7 90.4 72.3 – 108 193 154 – 231
Estriol (Free) (Unconjugated, uE3) ng/mL 2.25 1.59 – 2.88 5.76 4.03 – 7.49 11.8 9.51 – 14.1

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
PerkinElmer DELFIA Xpress (2) (continued)
hCG mIU/mL 7.50 5.30 – 9.80 25.0 19.0 – 31.0 189 151 – 227
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (ACET2) (REF 06769942190) µg/mL 10.2 7.21 – 13.3 34.9 26.6 – 43.2 99.1 77.0 – 121
Amikacin µg/mL 4.72 3.52 – 5.92 13.8 12.0 – 15.6 27.9 25.1 – 30.7
Carbamazepine (CARB4) µg/mL 2.79 2.04 – 3.54 7.55 6.22 – 8.89 13.4 11.3 – 15.4
Digoxin ng/mL 0.878 0.578 – 1.18 2.21 1.80 – 2.62 3.69 3.16 – 4.21
Ferritin ng/mL 74.6 61.8 – 87.4 133 103 – 162 292 218 – 366
Gentamicin (GENT2) µg/mL 2.38 1.48 – 3.28 4.96 3.23 – 6.69 8.59 6.03 – 11.2
Gentamicin (QMS) µg/mL 2.54 1.74 – 3.35 4.84 3.84 – 5.85 8.14 6.87 – 9.42
Iron µg/dL 129 117 – 140 81.1 71.7 – 90.5 70.0 61.2 – 78.9
Iron (TIBC) (2) µg/dL 279 234 – 323 245 210 – 280 218 175 – 261
Lithium mg/dL 0.424 0.304 – 0.544 1.10 0.947 – 1.26 1.66 1.47 – 1.85
Phenobarbital µg/mL 9.28 7.42 – 11.1 25.1 21.6 – 28.7 47.6 41.6 – 53.6
Phenytoin µg/mL 6.32 4.81 – 7.83 13.5 10.9 – 16.0 24.0 19.9 – 28.2
Salicylate mg/dL 3.98 3.39 – 4.57 15.7 14.0 – 17.4 46.3 41.7 – 50.9
Theophylline µg/mL 4.42 3.62 – 5.22 14.0 12.0 – 15.9 27.2 23.7 – 30.7
Tobramycin µg/mL 0.973 0.722 – 1.22 3.25 2.81 – 3.68 6.50 5.79 – 7.20
Valproic Acid µg/mL 33.2 24.5 – 41.9 74.0 58.5 – 89.6 110 88.1 – 131
Vancomycin (VANC3) µg/mL 10.6 8.49 – 12.6 17.9 14.9 – 20.8 31.8 27.0 – 36.5
ROCHE COBAS INTEGRA
Acetaminophen (ACET2) µg/mL § § §
Carbamazepine µg/mL 2.77 2.39 – 3.14 7.56 6.44 – 8.68 14.1 12.0 – 16.3
Digoxin ng/mL § § §
Gentamicin µg/mL 2.17 1.73 – 2.61 3.98 3.16 – 4.79 6.28 4.98 – 7.58
Lithium mEq/L 0.492 0.288 – 0.696 1.37 1.17 – 1.58 2.17 1.95 – 2.40
Phenobarbital µg/mL 9.29 8.08 – 10.5 23.5 20.9 – 26.0 45.2 40.6 – 49.8
Phenytoin µg/mL 6.35 5.63 – 7.08 13.2 11.3 – 15.1 22.6 19.0 – 26.1
Salicylate mg/dL § § §
Theophylline µg/mL 4.48 3.72 – 5.25 14.3 12.8 – 15.9 28.1 25.3 – 30.9
Valproic Acid µg/mL 34.5 30.3 – 38.8 79.1 71.1 – 87.0 116 105 – 127
Vancomycin µg/mL 11.9 9.25 – 14.5 20.5 16.9 – 24.0 38.0 32.6 – 43.5
ROCHE ELECSYS / E170 / COBAS e SYSTEMS
ACTH (5) pg/mL 13.5 5.41 – 21.6 90.1 34.0 – 146 84.6 32.2 – 137
AFP ng/mL 18.7 14.1 – 23.3 101 80.6 – 122 214 171 – 257
Calcitonin pg/mL 37.2 28.2 – 46.1 241 196 – 285 441 360 – 521
CEA ng/mL 2.29 1.71 – 2.87 14.3 11.4 – 17.2 37.9 30.5 – 45.2
Cortisol µg/dL 4.23 3.22 – 5.25 16.5 13.7 – 19.3 30.0 25.1 – 34.8
Cortisol (II) µg/dL 4.08 3.09 – 5.07 15.8 13.0 – 18.5 29.4 24.6 – 34.1
C-Peptide ng/mL 1.26 0.906 – 1.61 5.52 4.42 – 6.62 8.46 6.84 – 10.1
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 99.4 74.6 – 124 193 149 – 236 785 627 – 942
Digoxin (Ref. 11820796) restand. ng/mL 0.801 0.593 – 1.01 2.09 1.72 – 2.46 3.53 2.98 – 4.08
Estradiol (III) pg/mL 92.2 67.8 – 117 177 142 – 213 374 312 – 436
Ferritin ng/mL 75.8 59.8 – 91.8 154 122 – 187 345 272 – 418
Folate (cobas e801) ng/mL 2.64 <2.00 – 3.95 6.54 4.76 – 8.32 14.7 12.0 – 17.4
Folate (III) (E170/e601/e602) (Ref. 07559992) (Europe/Asia) restand. ng/mL 2.93 1.62 – 4.23 7.19 5.31 – 9.07 15.1 12.4 – 17.8
Folate (III) (E170/e601/e602) (Ref. 07559992) restand. ng/mL § § §
Folate (III) (e411) (Ref. 07559992) (Europe/Asia) restand. ng/mL 2.68 1.37 – 3.99 7.56 5.63 – 9.50 16.2 13.5 – 18.9
Follicle Stimulating Hormone (FSH) mIU/mL 6.13 5.11 – 7.14 22.3 18.3 – 26.2 44.2 36.3 – 52.2
hCG (+ ß) mIU/mL 5.63 4.51 – 6.74 22.4 17.9 – 26.9 169 135 – 204
hCG (STAT) (2) mIU/mL 5.25 3.52 – 6.98 23.2 15.5 – 30.9 160 107 – 213
Human Growth Hormone (hGH) ng/mL 3.22 2.27 – 4.16 7.92 5.79 – 10.0 15.3 11.3 – 19.2
Immunoglobulin E (IgE) ng/mL 876 735 – 1017 249 209 – 290 268 225 – 312
Insulin µIU/mL 16.4 13.5 – 19.2 57.9 49.0 – 66.9 185 158 – 213
Luteinizing Hormone (LH) mIU/mL 1.85 1.54 – 2.17 21.8 18.6 – 25.0 71.4 61.9 – 81.0
Progesterone ng/mL 0.989 0.745 – 1.23 11.0 8.72 – 13.2 29.3 23.4 – 35.3

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (continued)
Progesterone (III) ng/mL 0.960 0.722 – 1.20 11.1 8.85 – 13.4 29.7 23.6 – 35.7
Prolactin ng/mL 8.40 7.04 – 9.75 24.2 20.4 – 28.1 53.2 45.3 – 61.2
Prostate Specific Antigen, Free (fPSA) (Cobas e411/e601/602) (Ref. Cat.
08828601) ng/mL 0.257 0.208 – 0.307 1.75 1.49 – 2.00 10.9 9.37 – 12.4
Prostate Specific Antigen, Free (fPSA) (Cobas e801) (Ref. Cat. 08828610) ng/mL 0.260 0.210 – 0.310 1.73 1.48 – 1.98 10.8 9.26 – 12.3
Prostate Specific Antigen, Total (e411/e601/602) (tPSA) (Ref. Cat.
08791686) ng/mL 0.931 0.774 – 1.09 3.29 2.78 – 3.79 19.5 16.6 – 22.4
Prostate specific Antigen, Total (tPSA) (Cobas e801) (Ref. Cat. 08791732) ng/mL 0.962 0.800 – 1.12 3.41 2.88 – 3.93 20.0 17.0 – 23.0
PSA (Free) ng/mL 0.261 0.195 – 0.328 1.70 1.43 – 1.96 10.7 9.07 – 12.4
PSA (Total) ng/mL 0.998 0.840 – 1.16 3.50 2.96 – 4.05 20.4 17.2 – 23.6
T3 Total (2) ng/mL 0.922 0.727 – 1.12 2.07 1.64 – 2.51 3.22 2.45 – 3.99
T3 Uptake/T-Uptake TBI 0.936 0.817 – 1.05 0.581 0.426 – 0.737 0.303 <0.200 – 0.481
T3 (Free) pg/mL 2.63 2.10 – 3.15 7.47 6.25 – 8.69 13.7 11.6 – 15.8
T3 (Free) (III) pg/mL 2.79 2.26 – 3.31 7.71 6.50 – 8.91 14.2 12.1 – 16.3
T4 Total (2) µg/dL 5.41 4.27 – 6.55 10.1 7.98 – 12.2 11.6 9.15 – 14.0
T4 (Free) (II) ng/dL 1.04 0.922 – 1.16 2.67 2.17 – 3.17 4.06 3.20 – 4.91
T4 (Free) (III) ng/dL 1.02 0.899 – 1.14 2.65 2.16 – 3.14 4.10 3.25 – 4.95
Testosterone (II) ng/mL 1.54 1.02 – 2.05 4.25 3.33 – 5.16 8.94 7.33 – 10.5
Thyroglobulin (Tg) (II) (2) ng/mL 8.36 6.10 – 10.6 7.46 5.45 – 9.47 9.33 6.81 – 11.8
Thyroid Stimulating Hormone (TSH) µIU/mL 0.516 0.404 – 0.628 5.92 4.53 – 7.32 41.0 31.9 – 50.1
Thyroid Stimulating Hormone (TSH) (Ref. 08429324/08443432) µIU/mL 0.515 0.464 – 0.566 5.55 4.91 – 6.19 37.9 33.4 – 42.5
Vitamin B12 II (E170/e601/e602) pg/mL 426 347 – 504 671 565 – 778 818 695 – 942
Vitamin B12 II (e411) pg/mL 359 285 – 433 592 494 – 689 714 603 – 826
Vitamin B12 (cobas e801) pg/mL 402 326 – 478 642 539 – 746 793 672 – 914
Vitamin B12 (E170/e601/e602) pg/mL 405 328 – 482 644 540 – 748 791 669 – 912
Vitamin B12 (e411) pg/mL § § §
ROCHE HITACHI / MODULAR
Iron µg/dL 129 117 – 140 81.1 71.7 – 90.5 70.0 61.2 – 78.9
Phenobarbital µg/mL 9.28 7.42 – 11.1 25.1 21.6 – 28.7 47.6 41.6 – 53.6
Phenytoin µg/mL 6.32 4.81 – 7.83 13.5 10.9 – 16.0 24.0 19.9 – 28.2
Theophylline µg/mL 4.42 3.62 – 5.22 14.0 12.0 – 15.9 27.2 23.7 – 30.7
Tobramycin µg/mL 0.973 0.722 – 1.22 3.25 2.81 – 3.68 6.50 5.79 – 7.20
Valproic Acid µg/mL 33.2 24.5 – 41.9 74.0 58.5 – 89.6 110 88.1 – 131
SIEMENS ADVIA CENTAUR CP
AFP ng/mL 19.9 14.1 – 25.6 106 69.2 – 143 220 142 – 298
Androstenedione ng/mL 0.531 <0.300 – 0.785 1.13 0.682 – 1.58 1.82 1.15 – 2.49
Carbamazepine (CARB) µg/mL 2.96 2.07 – 3.84 7.51 5.48 – 9.53 13.3 10.9 – 15.7
CEA ng/mL 1.90 1.38 – 2.42 16.7 12.5 – 20.8 44.6 33.6 – 55.7
Cortisol (COR) µg/dL 3.81 2.42 – 5.20 17.8 12.3 – 23.4 33.5 23.3 – 43.7
C-Peptide (CpS) ng/mL 0.940 0.604 – 1.28 4.48 3.31 – 5.64 7.06 5.28 – 8.83
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 73.8 53.0 – 94.6 141 103 – 178 514 382 – 645
Digoxin (DIG) ng/mL 0.779 0.569 – 0.988 2.19 1.76 – 2.61 3.67 3.05 – 4.28
Estradiol (eE2) pg/mL 95.7 59.8 – 132 267 190 – 343 742 553 – 930
Ferritin (FER) ng/mL 59.6 38.8 – 80.4 138 93.0 – 183 341 232 – 449
Ferritin (FER) (reagent lots 310 & higher) (2) ng/mL 57.0 42.8 – 71.3 132 99.3 – 165 327 245 – 408
Folate (FOL) ng/mL 3.22 2.16 – 4.28 7.13 5.07 – 9.19 13.0 9.40 – 16.5
Folate (FOL) DTT/ Releasing Agent lots expiring May 28, 2021 or later. (2) ng/mL 3.03 2.03 – 4.03 6.63 4.71 – 8.55 13.4 9.69 – 17.0
Follicle Stimulating Hormone (FSH) (2) mIU/mL 6.70 5.03 – 8.38 28.9 21.7 – 36.2 67.5 50.6 – 84.3
Gentamicin (GENT) µg/mL 1.72 1.09 – 2.34 4.19 2.90 – 5.47 8.88 5.93 – 11.8
hCG (ThCG) mIU/mL 7.88 6.32 – 9.44 26.4 21.0 – 31.8 166 132 – 201
Immunoglobulin E (IgE) (IgEJ) (2) IU/mL 362 272 – 453 87.7 66.5 – 109 118 89.7 – 146
Immunoglobulin E (IgE) (tIgE) IU/mL 362 254 – 470 87.7 56.8 – 119 118 79.7 – 157
Insulin (IRI) µIU/mL 17.0 12.1 – 21.9 57.8 43.6 – 71.9 173 132 – 214
Luteinizing Hormone (LH) mIU/mL 1.33 0.896 – 1.76 18.8 14.7 – 22.9 66.9 52.7 – 81.1
Phenobarbital (PHNB) µg/mL 11.4 8.39 – 14.4 29.7 19.6 – 39.8 57.9 37.0 – 78.8
Phenytoin (PHTN) µg/mL 6.98 5.01 – 8.94 14.3 10.7 – 17.8 27.9 21.2 – 34.6

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
Progesterone (PRGE) ng/mL 1.18 0.893 – 1.47 9.77 7.72 – 11.8 23.5 18.6 – 28.3
Prolactin (PRL) ng/mL 5.82 4.62 – 7.01 15.1 11.1 – 19.1 35.5 25.4 – 45.5
PSA (Total) (PSA) ng/mL 0.799 0.595 – 1.00 2.73 2.05 – 3.42 17.1 12.9 – 21.4
PSA, Complexed (cPSA) ng/mL 0.518 0.375 – 0.662 1.18 0.892 – 1.47 6.58 5.11 – 8.05
T3 (Free) (FT3) pg/mL 2.79 2.03 – 3.54 6.60 5.06 – 8.14 10.7 8.30 – 13.1
T3 (Total) (T3) ng/mL 0.904 0.706 – 1.10 2.30 1.80 – 2.80 3.76 2.95 – 4.58
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.12 0.924 – 1.31 1.57 1.29 – 1.84 1.86 1.54 – 2.19
T4 (Free) (FT4) ng/dL 0.861 0.614 – 1.11 2.06 1.50 – 2.62 2.97 2.18 – 3.77
T4 (Total) (T4) µg/dL 5.74 4.19 – 7.28 11.9 9.19 – 14.7 14.0 10.8 – 17.1
Testosterone (TSTO) ng/dL § § §
Testosterone II (TSTII) ng/dL 148 104 – 192 359 270 – 447 742 573 – 911
Theophylline (THEO2) µg/mL 4.15 2.32 – 5.98 13.2 9.66 – 16.8 25.0 18.8 – 31.1
Thyroid Stimulating Hormone (TSH) µIU/mL 0.503 0.155 – 0.851 6.18 3.20 – 9.16 40.7 21.4 – 59.9
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.342 0.266 – 0.418 4.80 3.71 – 5.88 33.8 26.1 – 41.5
Valproic Acid (VALP) µg/mL 35.8 28.8 – 42.8 78.6 63.1 – 94.2 118 95.5 – 141
Vancomycin (VANC) µg/mL 8.77 4.94 – 12.6 15.1 9.72 – 20.6 27.1 18.8 – 35.3
Vitamin B12 (VB12) pg/mL 391 275 – 506 678 508 – 848 830 631 – 1028
SIEMENS ADVIA CENTAUR SYSTEMS
AFP ng/mL 18.9 14.6 – 23.3 102 82.9 – 122 215 175 – 255
Androstenedione ng/mL 0.535 <0.300 – 0.790 1.11 0.665 – 1.55 1.78 1.12 – 2.44
Calcitonin (CALCT) pg/mL 24.0 10.2 – 37.9 218 158 – 278 407 302 – 512
Carbamazepine (CARB) µg/mL 2.81 1.81 – 3.81 7.66 5.28 – 10.0 14.2 9.97 – >18.0
CEA ng/mL 1.82 1.06 – 2.58 16.3 12.8 – 19.8 45.1 36.1 – 54.1
Cortisol (COR) µg/dL 3.68 2.58 – 4.77 17.3 12.5 – 22.1 29.3 21.1 – 37.4
C-Peptide (CpS) ng/mL 0.807 0.453 – 1.16 4.06 2.73 – 5.39 6.70 4.55 – 8.85
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 69.7 44.7 – 94.6 137 95.8 – 179 506 380 – 632
Digoxin (DIG) ng/mL 0.963 0.692 – 1.23 2.60 2.09 – 3.10 3.38 2.77 – 3.98
Estradiol (eE2) pg/mL 91.6 58.5 – 125 238 164 – 313 668 471 – 865
Ferritin (FER) ng/mL 62.4 48.4 – 76.4 143 110 – 177 347 264 – 430
Ferritin (FER) (reagent lots 310 & higher) (2) ng/mL 56.7 42.5 – 70.8 130 97.2 – 162 303 228 – 379
Folate (FOL) ng/mL 2.02 1.07 – 2.96 4.95 2.76 – 7.13 9.58 5.42 – 13.7
Folate (FOL) DTT/ Releasing Agent lots expiring May 28, 2021 or later. (2) ng/mL 1.72 0.911 – 2.52 4.62 2.58 – 6.65 10.2 5.76 – 14.6
Follicle Stimulating Hormone (FSH) (2) mIU/mL 7.11 5.34 – 8.89 26.0 19.5 – 32.5 62.9 47.2 – 78.7
Gentamicin (GENT) µg/mL 2.78 2.07 – 3.48 5.38 4.01 – 6.74 7.56 5.64 – 9.47
hCG (ThCG) mIU/mL 7.71 4.30 – 11.1 30.3 23.2 – 37.5 187 154 – 220
Immunoglobulin E (IgE) (IgEJ) (2) IU/mL 370 276 – 463 87.8 66.7 – 109 113 85.9 – 140
Immunoglobulin E (IgE) (tIgE) IU/mL 370 294 – 446 87.8 70.8 – 105 113 90.8 – 135
Insulin (IRI) µIU/mL 16.7 11.8 – 21.6 56.4 42.6 – 70.2 172 131 – 212
Luteinizing Hormone (LH) mIU/mL 1.27 0.985 – 1.55 19.1 15.4 – 22.8 65.4 52.5 – 78.3
Phenobarbital (PHNB) µg/mL 14.1 10.3 – 17.8 32.7 24.0 – 41.4 59.9 44.6 – 75.2
Phenytoin (PHTN) µg/mL 7.67 5.64 – 9.71 16.2 12.1 – 20.2 30.6 23.3 – 37.9
Progesterone (PRGE) ng/mL 1.17 0.771 – 1.57 9.86 6.87 – 12.8 24.5 17.1 – 31.8
Prolactin (PRL) ng/mL 5.83 4.76 – 6.89 15.5 12.4 – 18.5 33.6 26.9 – 40.3
PSA (Free) (fPSA) ng/mL 0.275 0.207 – 0.344 1.85 1.58 – 2.11 11.3 9.76 – 12.8
PSA (Total) (PSA) ng/mL 0.862 0.720 – 1.00 3.07 2.52 – 3.62 18.7 15.3 – 22.1
PSA, Complexed (cPSA) ng/mL 0.595 0.470 – 0.721 1.28 1.03 – 1.54 6.80 5.51 – 8.08
T3 (Free) (FT3) pg/mL 2.62 1.90 – 3.34 6.67 5.12 – 8.23 10.9 8.44 – 13.3
T3 (Total) (T3) ng/mL 0.861 0.589 – 1.13 2.11 1.64 – 2.58 3.52 2.84 – 4.21
T3 Uptake/T Uptake (TUp) (Unit) T Uptake Unit 1.09 0.871 – 1.30 1.31 1.07 – 1.54 1.68 1.38 – 1.97
T4 (Free) (FT4) ng/dL 0.838 0.627 – 1.05 1.98 1.53 – 2.43 2.78 2.16 – 3.40
T4 (Total) (T4) µg/dL 5.31 3.97 – 6.64 10.6 8.23 – 13.0 12.7 9.90 – 15.5
Testosterone (TSTII) ng/dL 186 121 – 251 385 262 – 509 736 510 – 963
Testosterone (TSTO) ng/dL § § §
Theophylline (THEO2) µg/mL 4.25 2.39 – 6.11 13.5 9.64 – 17.3 26.1 19.4 – 32.8
Thyroid Stimulating Hormone (TSH) µIU/mL 0.519 0.354 – 0.684 6.27 3.89 – 8.65 41.6 25.6 – 57.6

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR SYSTEMS (continued)
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.400 0.263 – 0.537 4.81 2.99 – 6.62 32.7 20.1 – 45.2
Valproic Acid (VALP) µg/mL 35.8 28.9 – 42.8 78.6 65.0 – 92.2 118 98.5 – 137
Vancomycin (VANC) µg/mL 7.97 5.77 – 10.2 14.0 10.6 – 17.5 25.1 19.4 – 30.8
Vitamin B12 (VB12) pg/mL 349 243 – 455 658 489 – 828 797 597 – 996
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (ACET) mg/dL 1.05 0.747 – 1.36 3.52 2.93 – 4.11 10.2 8.86 – 11.6
Carbamazepine (CARB_2) µg/mL 3.13 2.23 – 4.04 8.23 6.50 – 9.97 13.6 10.9 – 16.2
Digoxin (DIG) ng/mL 0.637 0.433 – 0.840 1.88 1.46 – 2.30 3.38 2.72 – 4.04
Ferritin (FRT) ng/mL 61.4 44.6 – 78.2 113 86.9 – 139 244 194 – 294
Gentamicin (GENT_2) µg/mL 2.27 1.62 – 2.92 4.50 3.54 – 5.46 7.48 6.18 – 8.78
Immunoglobulin A (IgA) (IGA_2) mg/dL 181 127 – 236 162 115 – 208 154 111 – 198
Immunoglobulin G (IgG) (IGG_2) mg/dL 787 647 – 928 735 605 – 866 691 569 – 813
Immunoglobulin M (IgM) (IGM_2) mg/dL 60.2 45.4 – 74.9 67.2 51.3 – 83.0 58.6 44.0 – 73.1
Iron (IRON_2) µg/dL 130 118 – 142 79.5 70.9 – 88.2 69.0 60.9 – 77.0
Lithium (LITH) mEq/L 0.480 0.377 – 0.583 1.32 1.14 – 1.50 2.03 1.78 – 2.28
Phenobarbital (PHNB_2) µg/mL 9.60 7.49 – 11.7 24.3 17.5 – 31.1 47.1 32.8 – 61.4
Phenytoin (PHNY_2) µg/mL 6.35 4.83 – 7.87 13.9 10.2 – 17.6 26.4 19.7 – 33.1
Salicylate (SAL) mg/dL 4.23 3.45 – 5.02 17.4 15.1 – 19.7 53.2 45.9 – 60.4
Theophylline (THEO_2) µg/mL 4.45 2.42 – 6.48 14.3 9.11 – 19.5 27.9 17.5 – 38.3
Tobramycin (TOB_2) µg/mL 0.967 0.662 – 1.27 3.03 2.53 – 3.54 5.85 5.07 – 6.63
Valproic Acid (VPA_2) µg/mL 33.7 24.1 – 43.4 77.6 59.6 – 95.5 117 91.0 – 144
Vancomycin (VANC_2) µg/mL 8.62 5.81 – 11.4 15.5 11.2 – 19.7 27.9 21.0 – 34.7
SIEMENS BN SERIES NEPHELOMETERS
Immunoglobulin A (IgA) mg/dL 187 152 – 223 159 129 – 190 152 123 – 181
Immunoglobulin E (IgE) IU/mL 345 294 – 396 82.7 65.8 – 99.5 108 86.6 – 130
Immunoglobulin G (IgG) mg/dL 840 678 – 1002 788 638 – 938 739 601 – 877
Immunoglobulin M (IgM) mg/dL 71.2 55.4 – 87.0 74.6 57.9 – 91.3 64.9 50.9 – 79.0
SIEMENS DIMENSION SERIES
Acetaminophen (ACTM) µg/mL 13.0 9.21 – 16.9 43.6 32.9 – 54.2 123 97.3 – 149
Carbamazepine (CRBM) µg/mL 2.65 2.08 – 3.22 7.42 6.17 – 8.66 13.4 11.3 – 15.5
Digoxin (DGNA) ng/mL 0.722 0.510 – 0.933 1.92 1.61 – 2.24 3.27 2.84 – 3.70
Ferritin (FERR) ng/mL 78.0 58.8 – 97.2 165 130 – 199 369 298 – 440
Folate (FOLA) (EXL LOCI MODULE) (RF644) ng/mL 2.41 1.45 – 3.37 6.05 3.90 – 8.19 12.3 8.12 – 16.5
Gentamicin (GENT) µg/mL 2.07 1.59 – 2.55 4.35 3.65 – 5.05 7.45 6.44 – 8.46
hCG mIU/mL 8.41 6.02 – 10.8 25.7 20.7 – 30.7 223 188 – 258
Immunoglobulin A (IgA) mg/dL 163 131 – 194 142 113 – 171 135 107 – 163
Immunoglobulin G (IgG) mg/dL 837 627 – 1046 755 547 – 964 706 497 – 914
Immunoglobulin M (IgM) mg/dL 61.9 45.1 – 78.7 72.9 54.9 – 90.8 60.8 44.1 – 77.5
Iron µg/dL 128 114 – 141 79.6 69.0 – 90.1 68.9 59.0 – 78.8
Iron (TIBC) µg/dL 280 236 – 325 255 213 – 297 225 185 – 265
Lithium (LI) mmol/L 0.386 0.228 – 0.543 1.16 0.964 – 1.36 1.84 1.61 – 2.07
Phenobarbital (PHNO) µg/mL 10.1 6.71 – 13.5 25.8 20.2 – 31.4 49.8 40.7 – 58.8
Phenytoin (PTN) µg/mL 6.93 5.05 – 8.82 15.2 12.2 – 18.2 27.7 23.2 – 32.1
PSA (Free) (FPSA) ng/mL 0.234 0.121 – 0.347 1.65 1.35 – 1.96 11.2 9.25 – 13.2
PSA (Total) (TPSA) ng/mL 0.912 0.702 – 1.12 3.26 2.67 – 3.84 19.7 16.5 – 23.0
Salicylate (SAL) mg/dL 5.07 4.27 – 5.86 17.1 14.8 – 19.4 47.0 40.2 – 53.9
T3 (Free) (FT3) pg/mL 2.23 1.74 – 2.72 7.63 6.37 – 8.88 15.2 12.8 – 17.5
T3 Uptake/T Uptake (%, TU) % Uptake § § §
T4 (Free) (EXL LOCI Module) ng/dL 0.902 0.701 – 1.10 2.33 1.84 – 2.82 4.54 3.61 – 5.46
T4 (Free) (Heterogeneous Module) ng/dL 0.872 0.475 – 1.27 2.26 1.56 – 2.96 4.49 3.30 – 5.67
T4 (Total) (T4) µg/dL 5.62 4.01 – 7.23 11.2 9.06 – 13.3 13.3 11.0 – 15.6
Theophylline (THEO) µg/mL 4.43 3.53 – 5.34 14.5 11.8 – 17.1 29.8 24.5 – 35.1
Thyroid Stimulating Hormone (TSH) µIU/mL 0.409 0.300 – 0.518 4.94 3.58 – 6.30 35.6 25.6 – 45.6
Thyroid Stimulating Hormone (TSH) (EXL LOCI Module) (TSHL) µIU/mL 0.426 0.353 – 0.498 5.18 3.76 – 6.60 38.1 25.5 – 50.8
Tobramycin (TOBR) µg/mL 0.467 0.174 – 0.760 2.67 2.10 – 3.23 5.80 4.85 – 6.75

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SIEMENS DIMENSION SERIES (continued)
Valproic Acid (VALP) µg/mL 34.0 28.4 – 39.7 75.4 62.6 – 88.2 110 91.4 – 129
Vancomycin (VANC) µg/mL 10.7 8.42 – 12.9 17.9 14.6 – 21.2 31.3 26.1 – 36.4
Vitamin B12 (VB12) (EXL LOCI MODULE) (RF642) pg/mL 411 296 – 526 627 460 – 794 764 564 – 965
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen (ACTM) µg/mL 14.3 10.1 – 18.4 44.7 38.8 – 50.6 125 114 – 135
AFP ng/mL 17.5 12.3 – 22.7 93.6 69.2 – 118 201 149 – 254
Amikacin µg/mL 4.62 3.25 – 5.99 13.7 9.24 – 18.2 23.4 15.5 – 31.2
Caffeine µg/mL 2.30 1.42 – 3.18 7.73 5.29 – 10.2 16.5 11.5 – 21.5
Carbamazepine (CRBM) µg/mL 2.70 2.20 – 3.20 7.22 6.17 – 8.28 12.8 11.0 – 14.5
CEA ng/mL 1.82 1.33 – 2.30 16.2 13.1 – 19.4 48.4 39.2 – 57.7
Digoxin (DGXN) ng/mL 0.807 0.575 – 1.04 2.07 1.62 – 2.53 3.70 3.04 – 4.35
Estradiol pg/mL 79.4 52.7 – 106 193 146 – 240 468 373 – 563
Ferritin (FERR) ng/mL 56.7 46.2 – 67.2 124 103 – 146 299 248 – 350
Folate (FOL) ng/mL 2.57 1.70 – 3.44 5.70 4.00 – 7.40 11.3 8.39 – 14.3
Follicle Stimulating Hormone (FSH) mIU/mL 5.85 4.83 – 6.88 20.7 17.2 – 24.3 36.7 30.5 – 43.0
Gentamicin (GENT) µg/mL 2.12 1.65 – 2.59 4.42 3.70 – 5.14 7.67 6.59 – 8.74
hCG (Beta, BHCG) mIU/mL 8.47 6.79 – 10.1 25.2 20.1 – 30.3 200 159 – 242
Immunoglobulin A (IgA) mg/dL 188 154 – 222 164 131 – 197 155 123 – 188
Immunoglobulin E (IgE) IU/mL 341 251 – 431 80.3 60.7 – 99.8 105 79.1 – 132
Immunoglobulin G (IgG) mg/dL 823 685 – 961 769 638 – 899 720 597 – 844
Immunoglobulin M (IgM) mg/dL 69.0 48.3 – 89.8 72.5 51.3 – 93.6 62.9 42.9 – 83.0
Iron µg/dL 131 116 – 145 81.8 69.1 – 94.4 70.5 58.2 – 82.7
Iron (TIBC) µg/dL 283 254 – 312 255 227 – 283 223 196 – 249
Lidocaine (LIDO) µg/mL 1.30 0.841 – 1.77 3.42 2.82 – 4.03 6.49 5.64 – 7.34
Lithium (LITH) mmol/L 0.490 0.369 – 0.611 1.24 1.06 – 1.41 1.87 1.65 – 2.09
Luteinizing Hormone (LH) mIU/mL 1.40 0.949 – 1.84 21.5 18.8 – 24.2 84.3 75.1 – 93.5
N-Acetyl Procainamide (NAPA) µg/mL 1.64 1.13 – 2.16 4.15 3.01 – 5.29 9.01 6.50 – 11.5
Phenobarbital (PHNO) µg/mL 9.83 6.72 – 12.9 24.5 20.2 – 28.9 44.7 38.7 – 50.8
Phenytoin (PTN) µg/mL 6.70 5.22 – 8.18 13.9 11.5 – 16.3 24.7 20.9 – 28.4
Procainamide (PROC) µg/mL 2.08 1.42 – 2.73 8.23 6.64 – 9.81 14.7 12.1 – 17.3
Progesterone (PROG) ng/mL 1.06 0.564 – 1.56 9.39 6.61 – 12.2 24.1 17.3 – 30.8
Prolactin (PRL) ng/mL 5.96 5.18 – 6.74 19.3 17.1 – 21.4 44.3 39.7 – 48.9
PSA (Free) (FPSA) ng/mL 0.236 0.161 – 0.311 1.67 1.41 – 1.92 10.9 9.14 – 12.6
PSA (Total) (TPSA) ng/mL 0.875 0.792 – 0.959 3.06 2.61 – 3.52 18.7 15.6 – 21.8
Salicylate (SAL) mg/dL 5.08 4.29 – 5.88 16.7 14.5 – 18.9 46.3 39.6 – 53.0
T3 (Free) (FT3) pg/mL 2.09 1.47 – 2.70 7.32 5.40 – 9.24 14.4 10.7 – 18.0
T3 Uptake/T Uptake (%, TU) % Uptake 34.0 28.0 – 40.0 40.7 33.4 – 47.9 46.5 38.2 – 54.8
T4 (Free) (FT4) ng/dL 0.890 0.727 – 1.05 2.18 1.82 – 2.54 4.08 3.43 – 4.73
T4 (Total) (T4) µg/dL 6.80 4.68 – 8.92 12.4 9.72 – 15.1 14.6 11.7 – 17.5
Theophylline (THEO) µg/mL 4.38 3.45 – 5.30 14.3 11.7 – 16.8 27.4 22.7 – 32.0
Thyroid Stimulating Hormone (TSH) µIU/mL 0.393 0.278 – 0.507 4.97 4.09 – 5.85 36.5 29.8 – 43.3
Tobramycin (TOBR) µg/mL 0.558 0.366 – 0.751 2.61 2.19 – 3.02 5.68 4.81 – 6.54
Valproic Acid (VALP) µg/mL 36.3 29.1 – 43.5 78.8 65.8 – 91.8 113 95.2 – 131
Vancomycin (VANC) µg/mL 10.8 8.62 – 13.0 18.0 14.9 – 21.1 31.4 26.6 – 36.2
Vitamin B12 (VB12) pg/mL 391 305 – 478 613 514 – 711 756 646 – 866
SIEMENS IMMULITE / IMMULITE 1000
AFP ng/mL 17.1 10.6 – 23.6 98.2 66.0 – 130 212 152 – 272
Androstenedione ng/mL 0.850 0.376 – 1.32 2.64 1.53 – 3.75 4.48 2.24 – 6.72
CEA ng/mL 2.33 1.24 – 3.42 20.9 15.6 – 26.2 54.8 41.6 – 67.9
Cortisol µg/dL 3.84 2.47 – 5.21 16.4 11.6 – 21.2 29.3 21.0 – 37.7
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 71.2 43.7 – 98.6 142 93.2 – 190 534 367 – 700
Estradiol pg/mL 90.0 56.4 – 123 261 177 – 345 617 429 – 806
Estriol (Free) (UE3) ng/mL 1.40 0.579 – 2.22 4.99 3.21 – 6.77 7.61 – >11.2
Ferritin ng/mL 61.6 45.7 – 77.5 122 89.0 – 154 277 201 – 353
Follicle Stimulating Hormone (FSH) mIU/mL 6.74 5.36 – 8.12 25.0 19.4 – 30.6 49.4 38.1 – 60.6

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE / IMMULITE 1000 (continued)
hCG mIU/mL 10.8 6.53 – 15.1 30.5 20.4 – 40.6 238 166 – 310
hCG (Turbo) mIU/mL 10.1 6.01 – 14.2 32.0 21.5 – 42.6 256 179 – 333
Human Growth Hormone (hGH) (LKGRH) ng/mL 2.76 1.56 – 3.96 7.07 4.38 – 9.76 13.3 8.47 – 18.2
Immunoglobulin E (IgE) (Rgt. Lots 401+) IU/mL 341 239 – 443 112 81.5 – 143 89.9 66.1 – 114
Insulin µIU/mL 5.05 <2.00 – 9.35 14.7 6.74 – 22.7 34.7 19.0 – 50.3
Luteinizing Hormone (LH) mIU/mL 1.36 0.872 – 1.84 19.1 14.5 – 23.6 62.1 47.6 – 76.6
Progesterone (LKPW1) ng/mL 0.975 0.566 – 1.38 8.88 5.46 – 12.3 23.2 14.1 – 32.3
Prolactin ng/mL 7.35 5.43 – 9.27 20.2 14.6 – 25.9 44.5 31.9 – 57.0
PSA (Free) ng/mL 0.198 0.105 – 0.291 1.48 1.04 – 1.93 9.39 6.56 – 12.2
PSA (Total) ng/mL 0.876 0.671 – 1.08 3.74 3.07 – 4.40 21.0 17.6 – 24.5
PSA (Total) (Gen. 3) ng/mL 0.745 0.561 – 0.928 2.61 2.12 – 3.09 17.6 14.7 – >20.0
T3 (Free) pg/mL 2.88 1.78 – 3.97 5.65 3.88 – 7.43 8.98 6.39 – 11.6
T3 (Total) ng/dL 68.5 <40.0 – 98.3 184 124 – 245 343 241 – 445
T3 Uptake/T Uptake % Uptake 28.6 22.6 – 34.5 34.5 27.9 – 41.0 44.2 35.4 – 52.9
T4 (Free) ng/dL 1.16 0.878 – 1.44 2.85 2.15 – 3.55 4.37 3.30 – 5.45
T4 (Total) µg/dL 5.23 3.89 – 6.56 11.0 8.42 – 13.6 12.9 9.94 – 15.9
Testosterone ng/dL 116 27.3 – 205 510 254 – 766 >1600
Thyroglobulin (Tg) ng/mL 2.00 1.09 – 2.90 1.40 0.581 – 2.22 1.99 1.08 – 2.90
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.427 0.335 – 0.520 4.84 3.44 – 6.25 33.3 23.3 – 43.2
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.456 0.357 – 0.556 5.16 3.65 – 6.66 33.3 23.3 – 43.2
Vitamin B12 pg/mL 416 219 – 614 778 515 – 1041 963 666 – >1200
SIEMENS IMMULITE 2000 / 2000 XPi
ACTH (5) pg/mL 27.0 13.0 – 41.0 299 161 – 436 315 177 – 452
AFP ng/mL 16.0 10.5 – 21.4 90.7 58.7 – 123 201 131 – 271
Androstenedione ng/mL 0.704 <0.300 – 1.18 2.84 1.58 – 4.11 5.33 2.63 – 8.02
Androstenedione (Rgt. Lots 450 and above) ng/mL 1.05 0.480 – 1.62 3.26 2.15 – 4.37 5.97 4.17 – 7.77
Calcitonin pg/mL 34.1 12.0 – 56.1 220 159 – 281 389 289 – 489
Carbamazepine µg/mL 2.34 1.57 – 3.10 6.60 5.04 – 8.17 11.9 9.38 – 14.5
CEA ng/mL 2.28 1.44 – 3.12 19.8 15.1 – 24.5 50.0 38.6 – 61.4
Cortisol µg/dL 4.01 2.75 – 5.27 17.3 12.8 – 21.9 31.5 23.5 – 39.5
Cortisol (Rgt. Lots 550 and above) µg/dL 3.22 2.13 – 4.31 15.0 11.1 – 18.8 27.4 20.6 – 34.2
C-Peptide ng/mL 0.918 0.653 – 1.18 5.30 4.11 – 6.49 8.65 6.75 – 10.6
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 65.9 44.5 – 87.4 130 92.1 – 168 487 358 – 617
Digoxin ng/mL 0.815 0.519 – 1.11 2.10 1.61 – 2.60 3.70 2.95 – 4.44
Estradiol pg/mL 101 68.5 – 133 290 221 – 360 652 513 – 792
Estriol (Free) ng/mL 1.43 0.789 – 2.08 4.70 3.27 – 6.13 10.1 7.39 – >12.0
Ferritin ng/mL 70.8 53.0 – 88.6 139 104 – 174 336 251 – 422
Folate ng/mL 3.64 2.45 – 4.84 8.05 5.46 – 10.6 17.9 13.2 – 22.6
Follicle Stimulating Hormone (FSH) mIU/mL 6.47 5.13 – 7.82 23.1 17.8 – 28.4 47.5 36.4 – 58.6
Gastrin pg/mL 105 66.6 – 144 469 328 – 609 877 622 – >1000
hCG mIU/mL 11.2 5.84 – 16.6 29.2 19.7 – 38.7 228 170 – 285
Human Growth Hormone (hGH) (L2KGRH/L5KGRH) ng/mL 3.08 1.47 – 4.69 7.64 4.21 – 11.1 14.1 8.11 – 20.2
IGF-1/Somatomedin C ng/mL 79.8 44.4 – 115 81.1 45.8 – 116 72.9 37.5 – 108
Immunoglobulin E (IgE) IU/mL 370 254 – 487 88.8 62.5 – 115 114 79.5 – 148
Luteinizing Hormone (LH) mIU/mL 1.32 0.975 – 1.66 17.9 13.2 – 22.6 59.5 43.7 – 75.3
Phenobarbital µg/mL 9.20 7.65 – 10.8 23.3 19.5 – 27.0 45.9 38.6 – 53.2
Phenytoin µg/mL 5.95 3.71 – 8.18 12.5 8.76 – 16.3 22.9 16.7 – 29.1
Progesterone ng/mL 0.901 0.583 – 1.22 7.68 5.34 – 10.0 20.1 14.1 – 26.1
Prolactin ng/mL 6.67 5.32 – 8.01 17.8 14.2 – 21.5 41.1 33.0 – 49.3
Prostatic Acid Phosphatase (PAP) ng/mL 1.72 1.26 – 2.18 21.5 16.7 – 26.3 55.7 45.4 – 66.0
PSA (Free) ng/mL 0.226 0.122 – 0.330 1.59 1.20 – 1.98 10.1 7.78 – 12.3
PSA (Total) ng/mL 0.832 0.384 – 1.28 3.39 2.03 – 4.75 20.8 13.1 – 28.4
T3 (Free) pg/mL 2.85 1.74 – 3.95 6.51 4.80 – 8.22 9.48 7.28 – 11.7
T3 (Total) ng/dL 75.1 51.7 – 98.5 192 149 – 235 355 285 – 426
T3 Uptake/T Uptake % Uptake 29.3 23.9 – 34.6 35.5 28.7 – 42.2 40.9 32.0 – 49.7

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE 2000 / 2000 XPi (continued)
T4 (Free) (L2KFT4/L5KFT4) ng/dL 1.07 0.839 – 1.30 2.63 2.10 – 3.17 3.83 3.06 – 4.60
T4 (Total) µg/dL 5.21 3.88 – 6.54 10.8 8.28 – 13.4 12.1 9.31 – 15.0
Testosterone ng/dL 127 76.1 – 178 499 319 – 678 971 – >1600
Theophylline µg/mL 4.44 2.68 – 6.20 14.7 10.4 – 18.9 28.5 20.9 – 36.2
Thyroglobulin (Tg) ng/mL 2.51 1.16 – 3.86 1.87 0.597 – 3.15 2.84 1.41 – 4.27
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.444 0.344 – 0.545 5.01 3.72 – 6.30 33.5 24.4 – 42.7
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.491 0.390 – 0.591 5.54 4.10 – 6.97 33.8 24.6 – 43.0
Thyroxine Binding Globulin (TBG) µg/mL 16.4 12.1 – 20.7 15.0 11.0 – 18.9 13.8 10.0 – 17.6
Valproic Acid µg/mL 31.6 24.6 – 38.6 77.0 62.7 – 91.2 125 103 – 147
Vitamin B12 pg/mL 373 267 – 479 689 477 – 901 840 575 – >1000
SNIBE MAGLUMI (2)
17-Alpha-Hydroxyprogesterone ng/mL 0.675 0.473 – 0.878 2.04 1.43 – 2.65 6.93 4.85 – 9.01
AFP IU/mL 14.6 10.2 – 19.0 80.5 56.4 – 105 175 123 – 228
Aldosterone pg/mL 97.8 68.5 – 127 225 158 – 293 673 471 – 875
Androstenedione ng/mL 0.932 0.652 – 1.21 2.35 1.65 – 3.06 4.01 2.81 – 5.21
CEA ng/mL § § §
Cortisol ng/mL 41.7 29.2 – 54.2 181 127 – 235 370 259 – 481
C-Peptide ng/mL 1.47 1.03 – 1.91 6.14 4.30 – 7.98 9.70 6.79 – 12.6
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 84.5 59.2 – 110 189 132 – 246 628 440 – 816
Digoxin ng/mL 0.527 0.369 – 0.685 2.30 1.61 – 2.99 3.78 2.65 – 4.91
Estradiol pg/mL § § §
Estriol (Free) ng/mL § § §
Ferritin ng/mL § § §
Folate ng/mL § § §
Follicle Stimulating Hormone (FSH) mIU/mL 6.11 4.28 – 7.94 23.2 16.2 – 30.2 50.7 35.5 – 65.9
Gastrin pg/mL 25.2 17.6 – 32.8 156 109 – 203 275 193 – 358
hCG mIU/mL 6.25 4.38 – 8.13 25.4 17.8 – 33.0 230 161 – 299
Human Growth Hormone (hGH) ng/mL 3.24 2.27 – 4.21 10.1 7.07 – 13.1 19.3 13.5 – 25.1
Immunoglobulin E (IgE) IU/mL 316 221 – 411 79.4 55.6 – 103 104 73.0 – 135
Insulin µIU/mL 16.5 11.6 – 21.5 59.7 41.8 – 77.6 164 115 – >200
Luteinizing Hormone (LH) mIU/mL 2.66 1.86 – 3.46 24.0 16.8 – 31.2 81.2 56.8 – 106
Progesterone ng/mL 0.856 0.599 – 1.11 12.6 8.82 – 16.4 30.0 21.0 – 39.0
Prolactin µIU/mL 139 97.3 – 181 369 258 – 480 840 588 – 1092
PSA (Free) ng/mL 0.240 0.144 – 0.336 1.50 1.05 – 1.95 11.3 7.91 – 14.7
PSA (Total) ng/mL 0.798 0.559 – 1.04 2.81 1.97 – 3.65 16.9 11.8 – 22.0
T3 (Free) pg/mL 2.41 1.69 – 3.13 7.19 5.03 – 9.35 14.9 10.4 – 19.4
T3 (Total) ng/mL 0.711 0.498 – 0.924 1.59 1.11 – 2.07 2.69 1.88 – 3.50
T4 (Free) pg/mL 10.9 7.63 – 14.2 28.2 19.7 – 36.7 49.6 34.7 – 64.5
T4 (Total) ng/mL 64.1 44.9 – 83.3 117 81.9 – 152 137 95.9 – 178
Testosterone ng/mL 0.783 0.548 – 1.02 4.30 3.01 – 5.59 9.72 6.80 – 12.6
Testosterone (Free) pg/mL 4.25 2.98 – 5.53 15.9 11.1 – 20.7 45.1 31.6 – 58.6
Thyroid Stimulating Hormone (TSH) µIU/mL 0.475 0.333 – 0.618 5.38 3.77 – 6.99 39.5 27.7 – 51.4
Vitamin B12 pg/mL 344 241 – 447 518 363 – 673 712 498 – 926
TOSOH AIA SYSTEMS (2)
25-Hydroxy Vitamin D (AIA-PACK) ng/mL 15.0 10.5 – 19.5 26.4 18.5 – 34.3 21.3 14.9 – 27.7
ACTH (ST AIA-PACK) (5) pg/mL 19.8 13.8 – 25.7 162 113 – 210 141 98.8 – 184
AFP (ST AIA-PACK) ng/mL 18.4 12.9 – 23.9 94.4 66.1 – 123 198 139 – 257
CEA (ST AIA-PACK) ng/mL 2.80 2.00 – 3.60 18.8 13.2 – 24.4 43.2 30.2 – 56.2
Cortisol (ST AIA-PACK) µg/dL 4.20 2.90 – 5.50 18.4 12.9 – 23.9 32.9 23.0 – 42.8
C-Peptide (II, ST AIA-PACK) ng/mL 1.03 0.720 – 1.34 5.52 3.86 – 7.18 9.10 6.37 – 11.8
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (ST AIA-PACK) µg/dL 82.8 58.0 – 108 167 117 – 217 589 413 – 766
Estradiol (REF E2-025274) pg/mL 249 174 – 323 542 380 – 705 1132 792 – 1472
Estradiol (REF HSE2-025225) pg/mL 90.2 63.1 – 117 216 151 – 281 462 323 – 601
Ferritin (ST AIA-PACK) ng/mL 52.1 36.5 – 67.7 101 70.5 – 131 238 167 – 310
Folate (AIA-PACK) ng/mL 6.04 3.58 – 8.50 12.5 7.62 – 17.3 18.6 13.0 – >20.0

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 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

INSTRUMENT (1)
Level 1 - 40391 Level 2 - 40392 Level 3 - 40393
Units Mean Range Mean Range Mean Range
TOSOH AIA SYSTEMS (2) (continued)
Follicle Stimulating Hormone (FSH) (ST AIA-PACK) mIU/mL 7.70 5.40 – 10.0 24.8 17.4 – 32.2 37.3 26.1 – 48.5
hCG (Total Beta, ST AIA-PACK) mIU/mL 8.80 6.20 – 11.4 27.0 18.9 – 35.1 195 137 – 254
Human Growth Hormone (hGH) (ST AIA-PACK) ng/mL 3.15 2.21 – 4.10 8.40 5.88 – 10.9 16.3 11.4 – 21.2
Immunoglobulin E (IgE) (II, ST AIA-PACK) IU/mL 332 232 – 431 83.4 58.4 – 108 110 77.1 – 143
Insulin (IRI, ST AIA-PACK) µIU/mL 17.7 12.4 – 23.0 61.7 43.2 – 80.2 168 117 – 218
Luteinizing Hormone (LH) (II, ST AIA-PACK) mIU/mL 1.20 0.800 – 1.60 18.2 12.7 – 23.7 68.8 48.2 – 89.4
Progesterone (ST AIA-PACK, Cat.No.0036281) ng/mL 0.365 0.256 – 0.475 11.4 7.98 – 14.8 32.3 22.6 – >40.0
Progesterone (ST AIA-PACK, PROGII) ng/mL 0.410 0.290 – 0.530 11.9 8.33 – 15.5 33.9 23.7 – >40.0
Progesterone (ST AIA-PACK, PROGIII) (Cal Lot G33CC359) ng/mL 0.780 0.550 – 1.01 13.5 9.43 – 17.5 36.9 25.8 – >40.0
Prolactin ng/mL 1.20 <1.00 – 1.60 5.80 4.10 – 7.50 5.30 3.70 – 6.90
Prostatic Acid Phosphatase (PAP) (ST AIA-PACK) ng/mL 1.40 1.00 – 1.80 20.4 14.3 – 26.5 38.9 27.2 – >40.0
PSA (Total) (ST AIA-PACK) ng/mL 0.960 0.670 – 1.25 3.21 2.25 – 4.17 18.5 12.9 – 24.0
T3 (Free) (ST AIA-PACK) pg/mL 2.90 2.03 – 3.77 10.1 7.08 – 13.2 24.4 17.1 – >25.0
T3 (Total) (ST AIA-PACK) ng/mL 0.860 0.600 – 1.12 1.96 1.37 – 2.55 3.19 2.23 – 4.15
T3 Uptake/T Uptake (ST AIA-PACK) % Uptake 32.3 22.6 – 42.0 41.7 29.2 – 54.2 46.7 32.7 – >60.0
T4 (Free) (ST AIA-PACK) ng/dL 0.980 0.690 – 1.27 2.72 1.90 – 3.54 4.35 3.05 – 5.66
T4 (Total) (ST AIA-PACK) µg/dL 5.30 3.70 – 6.90 9.90 6.90 – 12.9 11.6 8.10 – 15.1
Testosterone (ST AIA-PACK) ng/dL 110 77.3 – 144 485 340 – 631 1389 972 – 1806
Thyroid Stimulating Hormone (TSH) (ST AIA-PACK) µIU/mL 0.400 0.280 – 0.520 5.03 3.52 – 6.54 33.3 23.3 – 43.2
Thyroid Stimulating Hormone (TSH) (TSH3G, AIA-PACK) µIU/mL 0.420 0.290 – 0.550 5.19 3.63 – 6.75 33.6 23.5 – 43.6
Vitamin B12 (AIA-PACK) pg/mL 414 290 – 538 760 532 – 988 981 687 – 1275
YHLO iFlash (2)
CEA ng/mL 2.08 1.37 – 2.82 14.5 9.50 – 19.6 38.6 25.4 – 52.4
C-Peptide ng/mL 1.55 1.02 – 2.10 6.25 4.11 – 8.48 9.27 6.09 – 12.6
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) ng/mL 789 518 – 1070 2149 1412 – 2916 7612 5004 – 10331
Ferritin ng/mL 70.7 46.5 – 95.9 157 103 – 214 376 247 – 510
Follicle Stimulating Hormone (FSH) mIU/mL 5.50 3.62 – 7.46 22.8 15.0 – 30.9 51.8 34.1 – 70.3
PSA (Total) ng/mL 1.06 0.700 – 1.44 4.54 2.98 – 6.16 27.0 17.7 – 36.6
T3 (Free) pg/mL 2.50 1.64 – 3.39 5.93 3.90 – 8.05 8.46 5.56 – 11.5
T4 (Free) pg/mL 5.83 3.83 – 7.91 13.0 8.55 – 17.6 19.8 13.0 – 26.9
T4 (Total) ng/mL 50.0 32.9 – 67.8 94.3 62.0 – 128 112 73.3 – 151
Thyroid Stimulating Hormone (TSH) µIU/mL 0.660 0.430 – 0.900 5.89 3.87 – 7.99 37.3 24.5 – 50.6

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(3) For the conversion factor, refer to the manufacturer’s instruction for use.
(4) Values are not suitable for the following method/instrument: Mindray CL-900i)
(5) No distinct recovery values may be observed between Levels 2 and 3 on some methods.
Data is not available at this time. Please inquire.
§ The data required to establish the means and acceptable ranges for this assay were not obtained due to limited assignment participation. If your facility is
interested in participating in the Value Assignment Program for this assay, please contact your local Bio-Rad office.
Not applicable

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