Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40411
371 Level 1 12 x 5 mL
0459 2024-09-30 40410 Level 2 40412
372 Level 2 12 x 5 mL
Level 3 40413
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

https://www.myeinserts.com/40410

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/40410. 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 • 2023-02 • 1536-00S

 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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10/22

© 2023 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2023-02 • 1536-00S
 Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
17-ALPHA-HYDROXYPROGESTERONE (2)
Diagnostics Biochem Canada ELISA ng/mL
DRG ELISA (EIA-1292) ng/mL 0.790 0.440 – 1.15 2.51 1.38 – 3.63 7.79 4.28 – 11.3
IBL ELISA ng/mL 0.550 0.190 – 0.900 2.10 1.16 – 3.05 6.35 3.49 – 9.21
MP BioMedicals ImmuChem CT RIA ng/mL § § §
MP BioMedicals ImmuChem DA RIA ng/mL § § §
ACETAMINOPHEN (2)
SEKURE (Sekisui Diagnostics) µg/mL 10.2 7.60 – 12.8 34.0 25.5 – 42.5 107 80.1 – 134
ACTH (2)
Biomerica ELISA pg/mL
AFP (2)
DRG ELISA (EIA-1468) ng/mL 32.4 21.4 – 43.5 153 101 – 205 >193
Monobind AccuBind ELISA ng/mL 19.5 13.1 – 25.9 112 75.2 – 149 239 160 – 318
Monobind AccuLite CLIA ng/mL 19.4 13.0 – 25.9 109 73.0 – 145 259 173 – 344
ALDOSTERONE (2)
Beckman Coulter RIA (DSL8600) pg/mL 138 89.8 – 186 286 200 – 372 887 576 – 1197
AMITRIPTYLINE
HPLC ng/mL § § §
ANDROSTENEDIONE
Beckman Coulter RIA (DSL3800) (2) ng/mL 0.480 0.330 – 0.620 1.33 1.00 – 1.66 2.59 1.94 – 3.24
Calbiotech ELISA (2) ng/mL 1.67 1.10 – 2.20 4.61 3.07 – 6.14 8.15 5.43 – >10.0
Diagnostics Biochem Canada ELISA (2) ng/mL
DRG ELISA (EIA-3265) (2) ng/mL 0.500 0.280 – 0.730 1.42 0.780 – 2.06 3.18 1.75 – 4.62
MP BioMedicals ImmuChem DA RIA (2) ng/mL § § §
Siemens Atellica Solution ng/mL 0.542 0.311 – 0.773 1.12 0.709 – 1.54 1.97 1.29 – 2.65
CALCITONIN
Biomerica ELISA (2) pg/mL
Siemens Atellica Solution (CALCT) (IM) pg/mL 36.6 21.6 – 51.5 129 92.7 – 166 480 361 – 598
CARBAMAZEPINE (2)
CEDIA II µg/mL 2.77 1.87 – 3.67 7.90 6.58 – 9.22 12.4 10.6 – 14.2
CEA (2)
Monobind AccuBind ELISA ng/mL 1.42 0.950 – 1.89 13.2 8.85 – 17.6 23.1 15.5 – 30.7
Monobind AccuLite CLIA ng/mL 1.64 1.04 – 2.25 13.9 9.29 – 18.4 22.3 14.9 – 29.6
CHLORAMPHENICOL
HPLC µg/mL § § §
CORTISOL (2)
DRG ELISA (EIA-1887) ng/mL 34.5 19.0 – 50.1 186 119 – 253 332 212 – 452
MP BioMedicals Corti-Cote RIA µg/dL § § §
MP BioMedicals ImmuChem CT RIA µg/dL § § §
C-PEPTIDE (2)
Calbiotech ELISA ng/mL 0.930 0.620 – 1.24 4.21 2.81 – 5.61 6.87 4.58 – 9.16
DRG ELISA (EIA-1293) ng/mL 0.970 0.530 – 1.40 5.65 3.11 – 8.19 8.75 4.81 – 12.7
Monobind AccuBind ELISA ng/mL 1.04 0.700 – 1.39 3.37 2.26 – 4.48 5.18 3.47 – 6.89
Monobind AccuLite CLIA ng/mL 1.00 0.670 – 1.34 3.43 2.30 – 4.57 5.29 3.54 – 7.04
DEHYDROEPIANDROSTERONE-SULFATE (DHEA-SULFATE) (2)
Beckman Coulter RIA DHEA-S-7 (DSL2700) ng/mL 590 443 – 738 1628 1140 – 2117 5149 3604 – 6693
Calbiotech ELISA µg/mL 1.25 0.840 – 1.67 2.48 1.65 – 3.31 8.41 5.60 – 11.2
DRG ELISA (EIA-1562) µg/mL 0.510 0.280 – 0.740 1.39 0.760 – 2.01 5.29 2.91 – 7.67
IBL ELISA µg/mL 0.760 0.490 – 1.02 1.95 1.27 – 2.63 7.35 4.77 – 9.92
Monobind AccuBind ELISA µg/mL 0.870 0.580 – 1.16 2.42 1.62 – 3.21 6.56 4.39 – >8.00
Monobind AccuLite CLIA µg/mL 0.840 0.560 – 1.12 2.62 1.75 – 3.48 7.40 4.96 – >8.00
MP BioMedicals ImmuChem CT RIA ng/mL § § §
DESIPRAMINE
HPLC ng/mL § § §
DIGOXIN (2)
Monobind AccuBind ELISA ng/mL 0.870 0.580 – 1.15 2.33 1.56 – 3.10 3.58 2.40 – >4.00

Page 3 English • 2023-02 • 1536-00S

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

METHOD (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
DIGOXIN (2) (continued)
Monobind AccuLite CLIA ng/mL 0.910 0.610 – 1.21 2.32 1.55 – 3.09 3.59 2.41 – >4.00
DISOPYRAMIDE
Emit µg/mL § § §
ESTRADIOL (2)
Beckman Coulter RIA US Estradiol (DSL4800) pg/mL 62.5 37.5 – 87.5 77.0 46.2 – 108 157 94.0 – 219
BioCheck EIA pg/mL § § §
Calbiotech ELISA pg/mL 92.1 61.2 – 123 222 148 – 296 585 390 – 780
DRG ELISA (EIA-2963) pg/mL 137 76.8 – 197 380 213 – 548 792 444 – 1141
Monobind AccuBind ELISA pg/mL 103 69.0 – 137 181 121 – 240 342 229 – 455
Monobind AccuLite CLIA pg/mL 99.3 66.5 – 132 185 124 – 246 356 239 – 473
MP BioMedicals ImmuChem CT RIA pg/mL § § §
MP BioMedicals ImmuChem DA RIA pg/mL § § §
ESTRIOL (FREE) (2)
Calbiotech ELISA ng/mL 5.01 3.34 – 6.68 13.4 8.93 – 17.9 26.2 17.5 – >30.0
DRG ELISA (EIA-1612) ng/mL 2.62 1.44 – 3.80 6.41 3.53 – 9.30 17.4 9.55 – 25.2
Monobind AccuBind ELISA ng/mL 3.20 2.14 – 4.25 8.37 5.61 – 11.1 16.2 10.9 – 21.6
Monobind AccuLite CLIA ng/mL 3.56 2.39 – 4.74 9.06 6.07 – 12.1 17.5 11.7 – 23.2
ESTROGEN (TOTAL) (2)
MP BioMedicals ImmuChem DA RIA pg/mL § § §
ETHOSUXIMIDE
Emit µg/mL 28.7 22.5 – 34.9 62.4 49.2 – 75.7 106 83.7 – 129
FERRITIN (2)
BioCheck EIA ng/mL § § §
Monobind AccuBind ELISA ng/mL 60.3 40.4 – 80.2 147 98.7 – 196 398 267 – 529
Monobind AccuLite CLIA ng/mL 71.1 47.6 – 94.5 155 104 – 206 394 264 – 524
FOLATE (2)
MP BioMedicals SimulTRAC SNB RIA ng/mL § § §
MP BioMedicals SimulTRAC SP RIA ng/mL § § §
FOLLICLE STIMULATING HORMONE (FSH) (2)
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 2.11 1.40 – 2.81 11.7 7.80 – 15.8 17.2 11.5 – 23.0
DRG ELISA (EIA-1288) mIU/mL 4.63 2.55 – 6.72 21.1 11.6 – 30.6 39.9 21.9 – 57.8
Monobind AccuBind ELISA mIU/mL 5.34 3.58 – 7.10 22.8 15.3 – 30.3 40.5 27.1 – 53.9
Monobind AccuLite CLIA mIU/mL 4.62 3.10 – 6.15 21.9 14.7 – 29.2 41.7 28.0 – 55.5
GASTRIN (2)
MP BioMedicals RIA pg/mL § § §
GENTAMICIN (2)
CEDIA II µg/mL 2.22 1.50 – 2.94 4.93 3.81 – 6.09 7.46 6.08 – 8.90
HCG (2)
BioCheck EIA mIU/mL § § §
DRG ELISA (EIA-1469) mIU/mL 31.1 19.3 – 42.9 202 126 – 279
Monobind AccuBind ELISA mIU/mL 6.67 4.47 – 8.88 18.3 12.3 – 24.4 219 147 – >250
Monobind AccuBind ELISA (Rapid hCG) mIU/mL 11.0 7.34 – 14.6 21.0 14.1 – 27.9 225 151 – >250
Monobind AccuLite CLIA mIU/mL 6.78 4.54 – 9.01 18.6 12.5 – 24.7 216 145 – >250
HCG-BETA SUBUNIT (2)
DRG ELISA (EIA-1911) mIU/mL 2.94 1.82 – 4.06 11.7 7.25 – 16.1 108 67.2 – 150
HUMAN GROWTH HORMONE (HGH) (2)
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 4.56 3.04 – 6.08 15.9 10.6 – 21.1 33.0 22.0 – >40.0
MEDIAGNOST ELISA µIU/mL 10.7 8.60 – 12.9 27.3 21.8 – 32.8 55.0 44.0 – 66.0
Monobind AccuBind ELISA µIU/mL 13.1 8.75 – 17.4 29.1 19.5 – 38.7 60.1 40.3 – 80.0
Monobind AccuLite CLIA µIU/mL 12.2 8.17 – 16.2 29.3 19.6 – 38.9 61.7 41.3 – 82.0
MP BioMedicals ImmuChem DA RIA ng/mL § § §
IGF-1/SOMATOMEDIN C (2)
MEDIAGNOST IGF-1 ELISA (IGFBP Blocked) ng/mL 113 90.0 – 135 115 92.0 – 139 124 99.0 – 149

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

METHOD (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
IGF-1/SOMATOMEDIN C (2) (continued)
MEDIAGNOST IGF-1 RIA (IGFBP Blocked) ng/mL 113 90.0 – 135 115 92.0 – 139 124 99.0 – 149
IMIPRAMINE
HPLC ng/mL § § §
IMMUNOGLOBULIN E (IGE)
BioCheck EIA (2) IU/mL § § §
ImmunoCAP total IgE IU/mL 376 304 – 448 97.7 74.0 – 121 120 92.3 – 147
Monobind AccuBind ELISA (2) IU/mL 391 262 – >400 93.9 62.9 – 125 118 79.0 – 157
Monobind AccuLite CLIA (2) IU/mL 399 268 – >400 92.3 61.9 – 123 107 71.8 – 142
INSULIN (2)
Calbiotech ELISA µIU/mL 19.8 13.2 – 26.4 69.5 46.3 – 92.7 >100
DRG ELISA (EIA-2935) µIU/mL 16.4 9.03 – 23.8 61.6 33.9 – 89.3 >100
Monobind AccuBind ELISA µIU/mL 11.5 7.67 – 15.2 43.4 29.1 – 57.7 145 96.8 – 192
Monobind AccuBind ELISA (Rapid Insulin) µIU/mL 12.4 7.98 – 16.8 41.2 27.6 – 54.8 145 97.0 – 192
Monobind AccuLite CLIA µIU/mL 12.4 8.28 – 16.4 43.6 29.2 – 58.0 149 99.8 – 198
MP BioMedicals ImmuChem CT RIA µIU/mL § § §
LIDOCAINE
Emit µg/mL 1.28 <1.00 – 1.65 3.82 2.91 – 4.73 6.76 5.22 – 8.30
LUTEINIZING HORMONE (LH) (2)
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 1.26 0.840 – 1.68 17.5 11.6 – 23.3 49.6 33.1 – >50.0
DRG Serum ELISA (EIA-1289) mIU/mL 23.5 12.9 – 34.0 69.1 38.0 – 100
Monobind AccuBind ELISA mIU/mL 1.95 1.24 – 2.67 29.4 19.7 – 39.0 99.3 66.5 – 132
Monobind AccuLite CLIA mIU/mL <5.00 30.2 20.2 – 40.2 98.8 66.2 – 131
N-ACETYL PROCAINAMIDE (NAPA) (2)
CEDIA µg/mL 1.59 <0.600 – 3.27 4.08 1.98 – 6.18 8.37 5.91 – 10.8
NORTRIPTYLINE
HPLC ng/mL § § §
PHENOBARBITAL (2)
CEDIA II µg/mL 7.76 4.76 – 10.8 22.2 18.9 – 25.5 46.6 40.3 – 52.9
PHENYTOIN (2)
CEDIA II µg/mL 6.55 4.87 – 8.23 14.2 12.2 – 16.1 26.2 23.6 – 28.8
PRIMIDONE
Emit µg/mL 3.43 2.62 – 4.24 6.02 4.84 – 7.19 11.0 9.12 – 12.9
PROCAINAMIDE (2)
CEDIA µg/mL 1.73 0.530 – 2.93 8.52 6.12 – 10.9 14.0 11.6 – 16.4
PROGESTERONE (2)
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL § § §
Diagnostics Biochem Canada ELISA ng/mL
DRG ELISA (EIA-1561) ng/mL 0.660 0.360 – 0.960 10.9 6.00 – 15.8 >40.0
Monobind AccuBind ELISA ng/mL 0.900 0.600 – 1.20 12.3 8.21 – 16.3 29.3 19.6 – 38.9
Monobind AccuLite CLIA ng/mL 1.05 0.690 – 1.41 12.9 8.65 – 17.2 31.1 20.8 – 41.3
MP BioMedicals ImmuChem CT RIA ng/mL § § §
MP BioMedicals ImmuChem DA RIA ng/mL § § §
PROLACTIN (2)
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 7.74 5.16 – 10.3 21.4 14.3 – 28.5 66.4 44.2 – 88.6
DRG ELISA (EIA-1291) ng/mL 5.12 2.82 – 7.42 13.9 7.66 – 20.2 30.8 17.0 – 44.7
Monobind AccuBind ELISA ng/mL 11.1 7.44 – 14.8 33.4 22.4 – 44.5 79.2 53.0 – >100
Monobind AccuLite CLIA ng/mL 10.8 7.24 – 14.4 28.4 19.0 – 37.7 74.1 49.6 – 98.5
MP BioMedicals ImmuChem CT IRMA ng/mL § § §
PROPRANOLOL
HPLC ng/mL § § §
PSA (TOTAL) (2)
Monobind AccuBind ELISA ng/mL <2.00 5.20 3.49 – 6.92 33.0 22.1 – 43.8

Page 5 English • 2023-02 • 1536-00S

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

METHOD (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
PSA (TOTAL) (2) (continued)
Monobind AccuLite CLIA ng/mL <2.00 5.21 3.49 – 6.92 31.0 21.2 – 42.1
SALICYLATE (2)
SEKURE (Sekisui Diagnostics) mg/dL <5.30 16.9 12.7 – 21.1 46.9 35.2 – 58.6
T3 (FREE) (2)
Calbiotech ELISA pg/mL 3.44 2.29 – 4.59 6.10 4.07 – 8.14 10.4 6.90 – 13.8
Monobind AccuBind ELISA pg/mL 2.58 1.73 – 3.43 5.44 3.64 – 7.23 8.36 5.60 – 11.1
Monobind AccuLite CLIA pg/mL 2.65 1.78 – 3.53 5.25 3.52 – 6.98 8.22 5.51 – 10.9
MP BioMedicals SPCS RIA pg/mL § § §
T3 (TOTAL) (2)
BioCheck EIA ng/mL § § §
Monobind AccuBind ELISA ng/mL 0.990 0.660 – 1.32 2.40 1.60 – 3.19 3.77 2.52 – 5.01
Monobind AccuLite CLIA ng/mL 1.15 0.770 – 1.53 2.52 1.69 – 3.35 3.78 2.53 – 5.03
MP BioMedicals SPCS RIA ng/dL § § §
T3 UPTAKE/T UPTAKE (2)
CEDIA % Uptake 35.9 31.8 – 39.9 42.4 37.4 – 47.3 45.7 40.4 – >50.0
DRI % Uptake 33.2 26.6 – 39.8 41.5 33.2 – 49.7 47.0 37.6 – >50.0
Monobind AccuBind ELISA % Uptake 29.5 25.8 – 33.2 36.9 33.3 – 40.4 44.9 41.5 – 48.4
Monobind AccuLite CLIA % Uptake 30.6 27.3 – 33.9 37.2 33.9 – 40.5 44.7 41.5 – 48.0
MP BioMedicals SPCS RIA % Uptake § § §
T4 (FREE) (2)
EUROIMMUN RIA CT ng/dL 1.36 1.09 – 1.63 3.13 2.50 – 3.76 4.95 3.96 – 5.95
Monobind AccuBind ELISA ng/dL 1.01 0.670 – 1.34 2.14 1.43 – 2.84 3.51 2.35 – 4.67
Monobind AccuLite CLIA ng/dL 1.07 0.710 – 1.42 2.35 1.57 – 3.13 3.55 2.38 – 4.71
MP BioMedicals SPCS RIA ng/dL § § §
T4 (TOTAL) (2)
BioCheck EIA µg/dL § § §
CEDIA µg/dL 6.87 5.70 – 8.04 11.2 9.32 – 13.1 16.1 13.4 – 18.7
DRI µg/dL 5.74 4.60 – 6.89 10.8 8.67 – 13.0 16.1 13.1 – 19.6
Monobind AccuBind ELISA µg/dL 5.39 3.61 – 7.17 11.6 7.78 – 15.4 15.4 10.3 – 20.5
Monobind AccuLite CLIA µg/dL 5.50 3.69 – 7.32 10.1 6.78 – 13.5 13.7 9.21 – 18.3
MP BioMedicals SPCS RIA µg/dL § § §
TESTOSTERONE (2)
BioCheck EIA ng/mL § § §
DRG ELISA (EIA-1559) ng/mL 1.57 0.910 – 2.23 4.60 2.67 – 6.53 10.2 5.91 – 14.5
MP BioMedicals ImmuChem DA RIA ng/mL § § §
TESTOSTERONE (FREE) (2)
Beckman Coulter RIA (DSL4900) pg/mL 2.57 1.54 – 3.60 11.2 6.74 – 15.7 31.9 19.1 – 44.7
THEOPHYLLINE (2)
CEDIA II µg/mL 4.15 2.20 – 6.10 14.2 10.8 – 17.4 26.5 22.7 – 30.2
THYROID STIMULATING HORMONE (TSH) (2)
BioCheck EIA µIU/mL § § §
Fortress Diagnostics µIU/mL
Monobind AccuBind ELISA µIU/mL 0.480 0.320 – 0.640 5.59 3.75 – 7.44 35.7 23.9 – >40.0
Monobind AccuBind ELISA (Rapid TSH) µIU/mL 0.580 0.330 – 0.830 5.52 3.70 – 7.35 38.4 25.7 – 51.0
Monobind AccuLite CLIA µIU/mL 0.560 0.370 – 0.740 5.48 3.67 – 7.29 35.6 23.9 – >40.0
Monobind AccuLite CLIA (Rapid TSH) µIU/mL 0.520 0.350 – 0.700 5.13 3.33 – 6.93 34.9 23.4 – 46.4
MP BioMedicals ImmuChem CT IRMA µIU/mL § § §
TOBRAMYCIN (2)
CEDIA µg/mL § § §
VALPROIC ACID (2)
CEDIA II µg/mL 30.2 22.7 – 37.7 73.0 59.5 – 86.5 114 94.9 – 133
VITAMIN B12 (2)
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 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
Abbott Alinity c Analyzer
Amikacin µg/mL 4.80 3.13 – 6.47 13.8 11.3 – 16.3 26.7 23.2 – 30.2
Carbamazepine µg/mL <1.90 8.18 6.91 – 9.44 11.5 9.96 – 13.1
Gentamicin µg/mL 2.24 1.46 – 3.02 4.85 3.97 – 5.74 7.13 6.13 – 8.12
Lithium mmol/L 0.452 0.355 – 0.548 1.19 1.03 – 1.34 1.66 1.48 – 1.85
Phenobarbital µg/mL 9.00 7.10 – 10.9 22.7 17.1 – 28.2 43.8 32.4 – 55.3
Phenytoin µg/mL 6.50 5.35 – 7.65 13.5 11.2 – 15.8 26.3 21.6 – 31.1
Salicylate mg/dL <5.00 14.9 12.3 – 17.6 43.0 36.1 – 50.0
Theophylline µg/mL 4.08 3.19 – 4.98 13.5 10.2 – 16.8 26.3 19.6 – 33.0
Tobramycin µg/mL 0.598 0.346 – 0.850 2.12 1.77 – 2.47 4.67 4.12 – 5.22
Valproic Acid µg/mL 34.3 27.4 – 41.2 71.5 59.3 – 83.6 114 95.8 – 131
Vancomycin µg/mL 6.88 5.21 – 8.54 18.5 15.9 – 21.1 31.0 27.4 – 34.6
Abbott Alinity i Analyzer
AFP ng/mL 15.6 13.7 – 17.6 91.2 79.8 – 103 193 169 – 218
CEA ng/mL 2.54 2.05 – 3.03 18.9 16.4 – 21.3 41.4 36.3 – 46.6
Cortisol µg/dL 3.18 2.38 – 3.98 14.6 12.4 – 16.7 24.0 20.7 – 27.4
C-Peptide ng/mL 1.32 0.979 – 1.67 5.09 3.99 – 6.20 7.74 6.15 – 9.33
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 69.0 56.7 – 81.3 171 142 – 199 701 595 – 808
Estradiol pg/mL 95.8 71.4 – 120 162 132 – 191 297 257 – 336
Ferritin ng/mL 65.5 54.6 – 76.4 251 205 – 298 708 602 – 813
Folate ng/mL 4.88 3.06 – 6.69 11.9 7.90 – 15.8 13.1 – >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 4.55 3.88 – 5.22 20.5 17.7 – 23.2 39.5 34.2 – 44.8
hCG mIU/mL 6.13 4.21 – 8.05 24.3 19.8 – 28.7 240 212 – 268
Luteinizing Hormone (LH) mIU/mL 1.03 0.893 – 1.17 13.7 11.9 – 15.6 47.9 41.3 – 54.5
Progesterone ng/mL 0.561 <0.500 – 0.785 8.13 6.47 – 9.80 24.0 19.3 – 28.6
Prolactin ng/mL 7.53 6.46 – 8.61 21.4 18.0 – 24.9 48.2 40.1 – 56.3
PSA (Free) ng/mL 0.322 0.266 – 0.378 2.35 1.93 – 2.76 14.4 11.8 – 16.9
PSA (Total) ng/mL 0.669 0.533 – 0.804 3.22 2.61 – 3.82 19.7 16.5 – 22.8
T3 (Free) pg/mL 2.49 1.81 – 3.16 7.31 5.92 – 8.69 13.6 11.6 – 15.6
T3 (Total) ng/mL 0.709 0.583 – 0.835 1.75 1.45 – 2.05 2.92 2.42 – 3.42
T3 Uptake/T Uptake T Uptake Unit 0.926 0.798 – 1.05 0.833 0.712 – 0.954 0.841 0.720 – 0.962
T4 (Free) ng/dL 0.865 0.743 – 0.987 2.12 1.64 – 2.61 3.65 2.71 – 4.58
T4 (Total) µg/dL 5.48 4.80 – 6.16 10.6 9.08 – 12.1 15.0 12.8 – 17.2
Testosterone ng/dL 168 132 – 204 376 295 – 457 885 691 – 1079
Thyroid Stimulating Hormone (TSH) µIU/mL 0.367 0.301 – 0.433 4.35 3.78 – 4.93 27.6 23.9 – 31.4
Vitamin B12 pg/mL 349 248 – 449 549 417 – 680 776 607 – 944
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen (MULTIGENT) µg/mL 10.2 7.72 – 12.6 33.9 30.0 – 37.7 105 97.5 – 113
Carbamazepine (5P05-21) µg/mL <1.90 8.04 5.96 – 10.1 11.7 9.39 – 14.0
Digoxin (MULTIGENT) ng/mL 0.723 0.530 – 0.916 1.78 1.48 – 2.08 3.47 3.01 – 3.92
Gentamicin (MULTIGENT) µg/mL 2.50 1.94 – 3.07 4.86 4.09 – 5.62 6.95 6.00 – 7.90
Immunoglobulin A (IgA) mg/dL 169 144 – 195 148 126 – 171 158 134 – 182
Immunoglobulin E (IgE) (MULTIGENT) IU/mL 347 302 – 392 72.9 50.4 – 95.3 95.3 71.9 – 119
Immunoglobulin G (IgG) mg/dL 850 669 – 1031 758 597 – 920 798 628 – 968
Immunoglobulin M (IgM) mg/dL 68.0 55.0 – 81.0 67.2 54.3 – 80.1 70.0 56.8 – 83.2
Iron µg/dL 112 99.0 – 125 74.6 63.7 – 85.5 73.1 62.3 – 84.0
Lithium (MULTIGENT) mEq/L 0.460 0.362 – 0.557 1.20 1.05 – 1.35 1.69 1.50 – 1.88
Phenobarbital (5P07-21) µg/mL 8.83 6.91 – 10.7 23.4 19.1 – 27.6 46.0 38.1 – 54.0
Phenytoin (5P08-21) µg/mL
Salicylate (MULTIGENT) mg/dL <5.00 14.6 11.9 – 17.2 43.0 38.5 – 47.6
Theophylline (5P06-21) µg/mL 4.37 3.57 – 5.18 14.5 12.0 – 16.9 28.3 23.4 – 33.2
Tobramycin (MULTIGENT) µg/mL 0.627 0.421 – 0.833 2.22 1.88 – 2.56 5.07 4.49 – 5.65
Valproic Acid (MULTIGENT) µg/mL 32.7 26.4 – 38.9 77.5 68.7 – 86.3 115 104 – 126
Vancomycin (MULTIGENT) µg/mL 5.98 4.58 – 7.38 16.9 14.2 – 19.6 31.6 27.1 – 36.0
ABBOTT ARCHITECT iSYSTEMS
AFP ng/mL 16.0 12.9 – 19.1 91.6 79.4 – 104 195 170 – 219

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
ABBOTT ARCHITECT iSYSTEMS (continued)
Carbamazepine (1P36-27) µg/mL 3.00 2.43 – 3.57 8.08 6.70 – 9.46 12.7 10.6 – 14.8
CEA ng/mL 2.34 1.66 – 3.01 18.2 14.9 – 21.4 40.2 33.4 – 47.0
Cortisol µg/dL 3.10 2.31 – 3.89 14.4 12.0 – 16.7 24.0 20.3 – 27.8
C-Peptide ng/mL 1.37 0.942 – 1.79 5.22 4.06 – 6.37 8.14 6.44 – 9.85
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 73.3 61.5 – 85.1 171 142 – 200 686 568 – 804
Digoxin ng/mL 0.599 0.450 – 0.748 1.71 1.46 – 1.96 3.12 2.74 – 3.51
Estradiol pg/mL 93.8 74.2 – 113 170 144 – 196 313 276 – 350
Ferritin ng/mL 68.7 54.8 – 82.6 250 192 – 308 632 495 – 769
Folate ng/mL 4.66 2.98 – 6.34 11.9 8.54 – 15.3 >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 4.56 3.75 – 5.37 21.1 17.6 – 24.5 41.1 34.2 – 47.9
Gentamicin µg/mL 2.31 1.96 – 2.65 5.04 4.16 – 5.91 7.61 6.24 – 8.99
hCG mIU/mL 5.95 3.97 – 7.93 23.1 18.3 – 28.0 224 185 – 263
Insulin µIU/mL 14.7 12.5 – 16.9 49.3 43.1 – 55.4 170 150 – 190
Luteinizing Hormone (LH) mIU/mL 1.08 0.813 – 1.34 14.9 11.9 – 17.8 51.9 41.7 – 62.2
Phenobarbital µg/mL 9.86 7.99 – 11.7 24.7 20.4 – 29.0 48.5 40.3 – 56.6
Phenytoin µg/mL 6.25 5.28 – 7.22 13.2 11.0 – 15.4 25.7 21.3 – 30.2
Progesterone ng/mL 0.517 0.335 – 0.699 8.15 6.33 – 9.97 26.9 20.9 – 32.8
Prolactin ng/mL 7.66 6.16 – 9.17 20.8 16.9 – 24.8 46.8 38.0 – 55.6
PSA (Free) ng/mL 0.308 0.264 – 0.351 2.20 1.80 – 2.60 14.3 11.6 – 17.1
PSA (Total) ng/mL 0.630 0.493 – 0.767 2.93 2.32 – 3.54 18.4 14.6 – 22.2
T3 (Free) pg/mL 2.45 1.80 – 3.10 6.63 5.03 – 8.22 11.9 9.13 – 14.8
T3 (Free) (7K63-02) pg/mL 2.79 2.06 – 3.51 7.23 5.49 – 8.96 13.4 10.2 – 16.5
T3 (Total) ng/mL 0.794 0.603 – 0.985 1.88 1.52 – 2.24 2.98 2.45 – 3.52
T3 Uptake/T Uptake T Uptake Unit 0.890 0.718 – 1.06 0.789 0.644 – 0.934 0.793 0.647 – 0.939
T4 (Free) ng/dL 0.904 0.792 – 1.02 2.10 1.59 – 2.61 3.65 2.61 – 4.69
T4 (Total) µg/dL 5.65 4.56 – 6.73 10.6 8.28 – 12.8 15.7 12.2 – 19.2
Testosterone ng/dL 181 133 – 229 419 326 – 512 962 766 – 1157
Theophylline µg/mL 4.29 3.48 – 5.10 14.1 11.1 – 17.0 26.2 20.7 – 31.7
Thyroid Stimulating Hormone (TSH) µIU/mL 0.351 0.222 – 0.480 3.95 3.26 – 4.65 27.3 22.8 – 31.8
Valproic Acid µg/mL 29.9 23.7 – 36.0 69.1 55.9 – 82.3 107 87.2 – 127
Vancomycin (1P30-28) µg/mL 7.49 6.25 – 8.73 21.3 17.8 – 24.8 37.7 31.5 – 43.9
Vitamin B12 pg/mL 340 243 – 437 542 400 – 684 748 560 – 936
BECKMAN COULTER ACCESS / 2 / 2i
AFP ng/mL 18.3 13.4 – 23.2 98.3 73.6 – 123 207 155 – 258
CEA (CEA2) ng/mL 2.20 1.73 – 2.66 18.1 14.6 – 21.6 39.3 31.7 – 46.9
Cortisol µg/dL 3.16 2.12 – 4.19 17.0 13.1 – 20.9 30.4 23.8 – 36.9
C-Peptide (2) ng/mL 1.12 0.900 – 1.35 3.61 2.89 – 4.34 5.97 4.77 – 7.16
Digoxin ng/mL 0.813 0.581 – 1.05 1.90 1.50 – 2.30 3.23 2.62 – 3.83
Estradiol pg/mL § § §
Estradiol (Sensitive) pg/mL 116 78.1 – 153 210 153 – 267 387 294 – 481
Estriol (Free) (Unconjugated Estriol) ng/mL 1.25 0.807 – 1.69 3.60 2.77 – 4.43 >6.90
Ferritin ng/mL 53.6 42.0 – 65.1 149 115 – 183 420 342 – 498
Folate (FOLW) ng/mL 4.36 3.25 – 5.47 10.1 7.82 – 12.3 17.8 14.0 – 21.5
Follicle Stimulating Hormone (FSH) (hFSH) (2) mIU/mL 6.12 4.60 – 7.64 23.8 18.1 – 29.4 41.5 31.6 – 51.3
hCG (Total ßhCG) (5th IS) mIU/mL 6.84 5.42 – 8.26 27.3 22.5 – 32.0 254 221 – 287
Insulin (Ultrasensitive Insulin) µIU/mL 15.5 12.4 – 18.6 52.1 42.8 – 61.3 187 155 – 219
Luteinizing Hormone (LH) (hLH) (2) mIU/mL 1.14 0.805 – 1.47 17.4 13.5 – 21.3 67.3 53.0 – 81.7
Progesterone ng/mL 0.595 0.366 – 0.824 9.89 7.91 – 11.9 26.0 21.0 – 31.0
Progesterone (P4DE) ng/mL 0.353 0.207 – 0.510 7.77 6.08 – 9.53 22.5 17.8 – 27.3
Prolactin ng/mL 6.10 4.96 – 7.23 16.6 13.5 – 19.8 36.0 29.2 – 42.9
PSA (Free) (Hybritech free PSA) ng/mL 0.401 0.323 – 0.479 2.39 1.97 – 2.81 15.9 13.1 – 18.6
PSA (Free) (WHO 96/668) ng/mL 0.316 0.254 – 0.377 1.94 1.55 – 2.28 12.6 10.3 – 14.7
PSA (Total) (Hybritech PSA) ng/mL 0.810 0.652 – 0.968 3.65 3.02 – 4.27 23.5 19.6 – 27.4
PSA (Total) (WHO 96/670) ng/mL 0.684 0.551 – 0.818 2.84 2.35 – 3.33 18.3 15.3 – 21.3
T3 (Free) (Free T3) (2) pg/mL 2.43 1.95 – 2.91 5.83 4.67 – 6.99 9.42 7.54 – 11.3

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
BECKMAN COULTER ACCESS / 2 / 2i (continued)
T3 (Total) (Total T3) ng/mL 0.953 0.675 – 1.23 2.06 1.60 – 2.51 3.63 2.95 – 4.31
T3 Uptake/T Uptake % Uptake 44.3 35.8 – 52.8 49.6 40.3 – 58.9 54.2 44.1 – 64.3
T4 (Free) (Free T4) ng/dL 0.921 0.747 – 1.09 2.49 2.04 – 2.95 4.16 3.41 – 4.92
T4 (Total) (Total T4) µg/dL 5.92 4.23 – 7.61 11.2 8.48 – 13.9 16.7 12.9 – 20.4
Testosterone ng/mL 1.14 0.871 – 1.41 3.70 2.96 – 4.44 9.20 7.45 – 11.0
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.416 0.341 – 0.491 4.66 3.63 – 5.68 35.9 27.9 – 43.9
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.401 0.328 – 0.474 4.70 3.66 – 5.73 32.6 25.3 – 39.9
Vitamin B12 pg/mL 261 196 – 326 433 326 – 539 620 469 – 772
BECKMAN COULTER AU SYSTEMS
Acetaminophen µg/mL <10.0 – 12.6 34.7 27.5 – 41.9 109 88.8 – 129
Carbamazepine µg/mL <2.00 – 3.46 7.90 6.03 – 9.77 12.2 9.46 – 14.9
Digoxin ng/mL 0.670 <0.200 – 1.15 1.80 1.11 – 2.49 3.25 2.28 – 4.22
Ferritin ng/mL 64.1 49.7 – 78.4 149 128 – 170 340 303 – 376
Gentamicin µg/mL 2.43 1.85 – 3.02 5.13 3.95 – 6.32 7.87 6.06 – 9.67
Immunoglobulin A (IgA) mg/dL 170 145 – 195 153 129 – 177 154 130 – 178
Immunoglobulin G (IgG) mg/dL 803 670 – 937 724 606 – 841 744 623 – 866
Immunoglobulin M (IgM) mg/dL 58.8 43.7 – 73.9 58.3 43.3 – 73.3 61.8 46.2 – 77.5
Lithium mEq/L 0.500 0.343 – 0.657 1.20 1.03 – 1.37 1.70 1.52 – 1.88
Phenobarbital µg/mL 9.45 7.24 – 11.7 24.4 19.3 – 29.4 48.5 38.7 – 58.2
Phenytoin µg/mL 6.20 4.60 – 7.80 13.9 10.0 – 17.7 26.3 19.0 – 33.5
Salicylate mg/dL 3.83 2.86 – 4.81 14.8 12.1 – 17.4 42.9 36.0 – 49.8
T4 (Total) (DRI) µg/dL 6.00 4.66 – 7.34 11.7 10.0 – 13.3 14.0 12.1 – 15.8
Theophylline µg/mL 4.37 3.48 – 5.25 14.7 10.6 – 18.8 26.9 19.0 – 34.7
Tobramycin µg/mL 1.01 0.687 – 1.33 2.69 2.22 – 3.16 6.23 5.46 – 7.01
Valproic Acid µg/mL 34.2 25.9 – 42.5 74.5 60.8 – 88.2 114 94.6 – 133
Vancomycin µg/mL 6.19 4.13 – 8.25 15.2 11.8 – 18.6 27.4 22.2 – 32.7
BECKMAN COULTER SYNCHRON / UniCel DxC SERIES
Acetaminophen µg/mL 13.4 <10.0 – 19.5 41.2 32.6 – 49.9 125 108 – 143
Carbamazepine µg/mL 2.18 <2.00 – 2.85 7.63 6.27 – 9.00 12.1 10.1 – 14.0
Digoxin ng/mL 0.817 0.413 – 1.22 1.98 1.46 – 2.50 3.45 2.78 – 4.12
Gentamicin µg/mL 2.52 1.65 – 3.39 5.75 4.65 – 6.85 8.75 7.44 – 10.1
Immunoglobulin A (IgA) mg/dL § § §
Immunoglobulin G (IgG) mg/dL § § §
Immunoglobulin M (IgM) mg/dL § § §
Iron µg/dL 110 91.0 – 130 72.7 56.3 – 89.1 71.3 54.9 – 87.6
Lithium (Infinity) mEq/L 0.456 0.300 – 0.612 1.20 0.994 – 1.40 1.70 1.46 – 1.93
Phenobarbital µg/mL 9.26 7.27 – 11.3 24.2 19.8 – 28.6 47.1 39.0 – 55.2
Phenytoin µg/mL 6.70 5.57 – 7.82 13.8 11.7 – 15.9 25.3 21.7 – 29.0
Salicylate mg/dL <4.00 15.4 12.9 – 17.9 44.8 40.0 – 49.6
Theophylline µg/mL 4.18 3.52 – 4.85 13.8 11.9 – 15.7 26.4 22.9 – 29.9
Tobramycin µg/mL 0.863 <0.500 – 1.33 3.09 2.49 – 3.69 7.08 6.20 – 7.95
Valproic Acid µg/mL 30.1 16.6 – 43.7 69.5 54.5 – 84.6 109 91.7 – 126
Vancomycin µg/mL 5.25 3.89 – 6.61 16.2 13.4 – 18.9 31.0 26.2 – 35.7
BECKMAN COULTER UniCel DxI
AFP ng/mL 15.7 11.8 – 19.6 88.6 65.7 – 112 192 142 – 242
CEA (CEA2) ng/mL 2.14 1.62 – 2.65 17.1 13.0 – 21.2 36.2 27.5 – 44.8
Cortisol µg/dL 2.92 1.88 – 3.95 15.2 11.5 – 18.9 27.4 21.1 – 33.7
C-Peptide (2) ng/mL 1.07 0.860 – 1.28 3.63 2.90 – 4.35 5.79 4.63 – 6.95
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 58.3 42.5 – 74.1 135 100 – 170 457 344 – 570
Digoxin ng/mL 0.813 0.581 – 1.05 1.90 1.50 – 2.30 3.23 2.62 – 3.83
Estradiol pg/mL § § §
Estradiol (Sensitive) pg/mL 106 81.8 – 129 192 162 – 222 362 320 – 405
Estriol (Free) (Unconjugated Estriol) ng/mL 1.25 0.807 – 1.69 3.60 2.77 – 4.43 >6.90
Ferritin ng/mL 54.4 41.7 – 67.0 158 120 – 197 377 293 – 460
Folate (FOLW) ng/mL 4.67 3.51 – 5.83 11.1 8.75 – 13.4 18.2 14.6 – 21.9

Page 9 English • 2023-02 • 1536-00S

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
BECKMAN COULTER UniCel DxI (continued)
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 6.12 4.60 – 7.64 23.8 18.1 – 29.4 41.5 31.6 – 51.3
hCG (Total ßhCG) (5th IS) mIU/mL 6.97 5.46 – 8.48 26.7 21.8 – 31.5 259 224 – 294
Insulin (Ultrasensitive Insulin) µIU/mL 15.6 12.5 – 18.7 52.0 41.9 – 62.1 191 154 – 228
Luteinizing Hormone (LH) (hLH) mIU/mL 1.14 0.805 – 1.47 17.4 13.5 – 21.3 67.3 53.0 – 81.7
Progesterone ng/mL 0.718 0.511 – 0.925 10.6 8.27 – 13.0 28.8 22.4 – 35.1
Progesterone (P4DE) ng/mL 0.434 0.299 – 0.570 8.39 6.38 – 10.5 25.2 19.1 – 31.3
Prolactin ng/mL 5.94 4.70 – 7.17 16.2 12.8 – 19.5 33.6 26.7 – 40.5
PSA (Free) (Hybritech free PSA) ng/mL 0.363 0.268 – 0.457 2.42 1.92 – 2.93 14.6 11.6 – 17.5
PSA (Free) (WHO 96/668) ng/mL 0.286 0.211 – 0.360 1.96 1.51 – 2.38 11.5 9.20 – 13.8
PSA (Total) (Hybritech PSA) ng/mL 0.792 0.627 – 0.956 3.52 2.84 – 4.19 21.3 17.2 – 25.3
PSA (Total) (WHO 96/670) ng/mL 0.669 0.530 – 0.808 2.74 2.21 – 3.26 16.6 13.4 – 19.7
T3 (Free) (Free T3) pg/mL 2.44 1.72 – 3.15 5.42 3.64 – 7.20 7.98 5.24 – 10.7
T3 (Total) (Total T3) ng/mL 0.862 0.582 – 1.14 1.91 1.41 – 2.41 3.13 2.38 – 3.88
T3 Uptake/T Uptake % Uptake 44.3 36.2 – 52.4 48.9 40.1 – 57.6 54.0 44.6 – 63.5
T4 (Free) (Free T4) ng/dL 0.927 0.707 – 1.15 2.50 1.98 – 3.02 4.48 3.58 – 5.39
T4 (Total) (Total T4) µg/dL 5.93 4.19 – 7.68 11.4 8.67 – 14.1 16.3 12.6 – 19.9
Testosterone ng/mL 1.19 0.930 – 1.46 3.65 2.84 – 4.45 8.26 6.42 – 10.1
Thyroid Stimulating Hormone (TSH) (3rd IS) µIU/mL 0.400 0.339 – 0.461 4.58 3.49 – 5.67 32.8 24.8 – 40.9
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.429 0.363 – 0.494 4.95 3.75 – 6.14 32.6 24.5 – 40.7
Vitamin B12 pg/mL 245 175 – 315 433 318 – 548 650 483 – 817
BIOMÉRIEUX VIDAS
AFP ng/mL 16.1 7.89 – 24.3 102 73.0 – 130 219 161 – 277
CEA (S) ng/mL 1.58 1.10 – 2.06 9.81 7.38 – 12.2 17.4 13.1 – 21.6
Digoxin ng/mL 0.707 0.430 – 0.984 1.94 1.43 – 2.46 3.70 2.90 – 4.49
Estradiol (II) pg/mL 125 89.4 – 160 329 258 – 400 782 632 – 933
Ferritin ng/mL 59.9 38.6 – 81.2 150 97.3 – 203 356 231 – 481
Follicle Stimulating Hormone (FSH) mIU/mL 5.51 4.18 – 6.84 23.6 18.5 – 28.6 47.7 37.4 – 57.9
hCG mIU/mL 6.75 4.48 – 9.01 23.5 16.6 – 30.3 305 222 – 388
Immunoglobulin E (IgE) (Total) IU/mL 351 253 – 448 82.6 61.1 – 104 106 77.9 – 134
Luteinizing Hormone (LH) mIU/mL 1.41 1.15 – 1.66 16.1 12.7 – 19.4 62.7 49.5 – 76.0
Progesterone ng/mL 0.680 <0.250 – 1.20 13.6 9.93 – 17.2 43.4 32.8 – 54.0
Prolactin ng/mL 6.87 4.42 – 9.31 18.9 13.8 – 24.1 39.2 29.4 – 48.9
PSA (Total) ng/mL 0.993 0.683 – 1.30 4.11 3.00 – 5.21 25.4 19.2 – 31.6
T3 (Free) pg/mL 2.45 1.61 – 3.29 7.33 5.34 – 9.32 13.5 10.1 – 17.0
T3 (Total) ng/mL 0.775 0.535 – 1.01 2.03 1.40 – 2.66 3.16 2.19 – 4.14
T4 (Free) (FT4N) (30459) ng/dL 1.04 0.707 – 1.38 2.98 2.31 – 3.66 5.39 4.28 – 6.51
T4 (Total) µg/dL 6.19 4.70 – 7.67 11.7 9.14 – 14.2 16.1 12.7 – 19.4
Thyroid Stimulating Hormone (TSH) µIU/mL 0.423 0.279 – 0.568 5.78 4.48 – 7.08 38.8 30.3 – 47.2
DIASORIN LIAISON (2)
Aldosterone ng/dL 10.9 7.64 – 14.2 24.3 17.0 – 31.6 59.9 41.9 – 77.8
CEA ng/mL 2.38 1.89 – 2.86 16.3 13.8 – 18.7 37.9 32.2 – 43.5
Cortisol µg/dL 2.46 1.94 – 2.98 17.2 14.3 – 20.1 34.0 28.9 – 39.1
C-Peptide ng/mL 1.68 1.19 – 2.17 6.06 4.85 – 7.28 8.97 7.18 – 10.8
Estradiol (II Gen) (310680) pg/mL 92.7 62.1 – 123 167 117 – 217 281 197 – 366
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 5.16 4.38 – 5.95 22.7 18.1 – 27.2 51.8 41.4 – 62.1
Luteinizing Hormone (LH) (US only) mIU/mL 1.62 1.15 – 2.09 25.0 21.2 – 28.7 108 92.0 – 124
Progesterone (II Gen) (310690) ng/mL 0.510 0.200 – 0.810 9.67 6.77 – 12.6 24.4 16.4 – 32.5
Prolactin (xt) µIU/mL 165 131 – 200 469 375 – 563 1041 833 – 1250
T3 (Free) pg/mL 2.42 2.06 – 2.79 10.3 8.76 – 11.9 22.5 19.2 – 25.9
T4 (Free) (US only) ng/dL 1.05 0.893 – 1.21 3.31 2.82 – 3.81 7.20 6.12 – >7.70
Testosterone ng/mL 0.530 0.210 – 0.850 2.05 1.44 – 2.67 4.78 3.34 – 6.21
DIASORIN LIAISON XL (2)
Aldosterone ng/dL 12.8 8.97 – 16.7 25.4 17.8 – 33.1 61.9 43.3 – 80.5
CEA ng/mL 2.44 1.91 – 2.98 17.0 14.4 – 19.5 40.6 34.5 – 46.7
Cortisol µg/dL 1.85 1.57 – 2.13 16.1 13.7 – 18.5 34.6 29.4 – 39.8

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
DIASORIN LIAISON XL (2) (continued)
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 55.0 38.5 – 71.5 126 88.4 – 164 488 261 – 715
Estradiol (II Gen) (310680) pg/mL 92.9 62.2 – 124 162 113 – 210 281 197 – 365
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 5.75 4.60 – 6.90 25.6 20.5 – 30.7 56.0 44.8 – 67.2
hCG (XL hCG) (REF 312321) mIU/mL 7.18 5.11 – 9.25 29.2 24.9 – 33.5 243 207 – 280
Luteinizing Hormone (LH) (US only) mIU/mL 1.98 1.68 – 2.28 26.2 22.3 – 30.1 111 94.6 – >125
Progesterone (II Gen) (310690) ng/mL 0.570 0.230 – 0.910 9.86 6.90 – 12.8 25.2 16.9 – 33.5
Prolactin (xt) µIU/mL 171 123 – 220 465 372 – 558 1041 832 – 1249
T3 (Free) pg/mL 2.62 2.23 – 3.01 10.5 8.84 – 12.2 23.5 19.4 – 27.5
T4 (Free) (US only) ng/dL 1.02 0.869 – 1.18 3.62 3.08 – 4.16 6.57 – >7.70
T4 (Total) µg/dL 4.05 2.95 – 5.15 6.58 5.26 – 7.90 8.48 6.79 – 10.2
Testosterone ng/mL 0.500 0.320 – 0.680 1.84 1.29 – 2.39 4.19 2.93 – 5.44
Testosterone XT ng/mL 0.650 0.420 – 0.890 2.55 1.78 – 3.31 5.49 3.84 – 7.14
Thyroid Stimulating Hormone (TSH) µIU/mL 0.590 0.440 – 0.740 6.07 5.03 – 7.11 44.2 37.6 – 50.9
IDS-iSYS (2)
Human Growth Hormone (hGH) (IS-3700) ng/mL 3.44 2.51 – 4.37 8.58 6.52 – 10.6 16.1 12.7 – 19.5
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (ACET) µg/mL 11.0 <10.0 – 13.3 40.4 34.0 – 46.8 129 112 – 145
Carbamazepine (CRBM) µg/mL <3.00 6.65 5.09 – 8.21 10.5 8.36 – 12.7
Digoxin (DGXN) ng/mL 0.932 0.502 – 1.36 1.92 1.42 – 2.42 3.22 2.63 – 3.81
Iron (Fe) µg/dL 112 98.6 – 126 70.8 59.7 – 82.0 67.6 56.6 – 78.6
Lithium (Li) mmol/L 0.768 0.575 – 0.961 1.75 1.50 – 1.99 2.28 2.01 – 2.55
Phenytoin (PHYT) µg/mL 5.74 4.50 – 6.98 12.6 10.1 – 15.1 24.6 20.0 – 29.2
Salicylate (SALI) mg/dL 5.15 4.35 – 5.95 17.2 15.2 – 19.3 36.1 32.1 – >40.0
Theophylline (THEO) µg/mL 3.77 1.92 – 5.63 13.8 10.9 – 16.7 29.9 25.2 – 34.5
ORTHO VITROS MICROTIP SERIES
Gentamicin (GENT) µg/mL 2.37 1.97 – 2.77 4.91 4.00 – 5.83 7.50 6.06 – 8.95
Tobramycin (TOBRA) µg/mL 1.05 0.844 – 1.26 2.77 2.33 – 3.21 6.20 5.26 – 7.14
Valproic Acid (VALP) µg/mL 31.5 20.5 – 42.5 73.4 56.0 – 90.8 113 89.7 – 137
Vancomycin (VANC) µg/mL 5.31 <5.00 – 6.87 13.8 11.2 – 16.4 24.0 20.1 – 27.8
ORTHO VITROS MICROWELL SERIES
AFP (2) (3) IU/mL 14.7 11.7 – 17.7 83.6 67.3 – 99.9 180 140 – 220
CEA ng/mL 2.44 1.97 – 2.92 16.9 14.3 – 19.5 38.8 33.0 – 44.6
Cortisol (Cort) µg/dL 2.74 2.09 – 3.38 15.7 12.3 – 19.1 27.8 21.8 – 33.7
C-Peptide (2) ng/mL 1.52 1.14 – 1.90 5.56 4.16 – 6.96 8.18 6.12 – 10.2
Estradiol (E2) (2) pg/mL 94.3 36.3 – 152 308 194 – 421 785 526 – 1045
Ferritin (Ferr) ng/mL 49.1 37.2 – 60.9 135 104 – 165 344 276 – 412
Folate (2) ng/mL 3.27 2.04 – 4.50 8.59 5.76 – 11.4 16.2 10.6 – >20.0
Follicle Stimulating Hormone (FSH) (2) mIU/mL 3.68 2.77 – 4.60 17.3 14.0 – 20.6 34.4 27.9 – 40.9
hCG (B-hCG) mIU/mL 8.54 6.25 – 10.8 23.6 18.9 – 28.4 276 231 – 322
Insulin (2) (3) µIU/mL 15.7 9.94 – 21.5 55.1 38.2 – 72.0 193 135 – 252
Luteinizing Hormone (LH) mIU/mL 1.07 0.617 – 1.52 20.4 17.0 – 23.8 64.5 54.3 – 74.6
Progesterone (Prog) (2) ng/mL 0.560 0.308 – 0.811 9.37 6.98 – 11.8 29.0 22.3 – 35.8
Prolactin (Prol) ng/mL 8.06 6.34 – 9.77 16.6 13.5 – 19.6 35.9 29.9 – 42.0
PSA (Total) (PSA) (680 1756) ng/mL 0.664 0.523 – 0.805 2.56 2.04 – 3.09 13.8 11.0 – 16.6
T3 (Free) (FT3 II) (2) pg/mL 4.64 3.38 – 5.91 15.1 11.5 – 18.8 >22.7
T3 (Free) (FT3) (2) pg/mL 4.65 3.38 – 5.92 17.5 12.8 – 22.3 >22.7
T3 (Total) (TT3) ng/mL 0.893 0.732 – 1.05 2.24 1.85 – 2.63 3.92 3.24 – 4.59
T3 Uptake/T Uptake (T3U) % Uptake 38.7 33.9 – 43.6 54.4 49.3 – 59.5 58.7 – >65.0
T4 (Free) (FT4) ng/dL 1.43 1.14 – 1.72 6.01 5.09 – 6.92 >6.98
T4 (Total) (TT4) (2) µg/dL 5.65 4.58 – 6.72 11.2 9.30 – 13.2 16.5 13.7 – 19.3
Testosterone (2) ng/dL 104 65.7 – 142 478 331 – 625 1288 922 – 1657
Thyroid Stimulating Hormone (TSH) µIU/mL 0.314 0.250 – 0.378 4.68 3.86 – 5.51 32.6 26.9 – 38.4
Vitamin B12 pg/mL 365 272 – 459 603 462 – 743 811 628 – 993
PerkinElmer AUTODELFIA (2)
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL § § §

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
PerkinElmer AUTODELFIA (2) (continued)
hCG mIU/mL 9.60 6.70 – 12.0 23.0 17.0 – 29.0 295 236 – 354
Luteinizing Hormone (LH) (hLH) mIU/mL § § §
Prolactin ng/mL § § §
T3 (Total) ng/mL 1.10 0.610 – 1.62 2.21 1.75 – 2.66 3.57 2.86 – 4.29
T4 (Free) ng/dL 1.32 0.930 – 1.71 4.96 3.95 – 5.97 >6.20
T4 (Total) µg/dL 5.97 4.19 – 7.75 9.77 7.83 – 11.7 13.3 10.7 – 16.0
Thyroid Stimulating Hormone (TSH) (hTSH Ultra) µIU/mL 0.440 0.350 – 0.530 4.80 3.80 – 5.80 35.0 28.0 – 42.0
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (ACET2) (REF 06769942190) µg/mL 9.61 7.45 – 11.8 32.5 27.3 – 37.7 103 88.1 – 118
Amikacin µg/mL 4.39 3.28 – 5.50 13.3 11.6 – 15.0 26.0 23.4 – 28.6
Carbamazepine (CARB4) µg/mL 2.84 2.14 – 3.54 8.23 6.83 – 9.63 13.3 11.2 – 15.3
Digoxin ng/mL 0.690 0.506 – 0.874 1.85 1.52 – 2.19 3.52 3.00 – 4.03
Ferritin ng/mL 80.7 65.2 – 96.2 181 139 – 222 417 318 – 517
Gentamicin (QMS) µg/mL 2.13 1.37 – 2.90 4.95 3.85 – 6.05 7.33 5.92 – 8.75
Iron µg/dL 108 97.0 – 118 74.7 65.6 – 83.8 73.7 64.7 – 82.8
Iron (TIBC) µg/dL 269 230 – 308 229 192 – 266 240 203 – 277
Lithium mg/dL 0.341 0.221 – 0.461 0.874 0.730 – 1.02 1.22 1.06 – 1.39
Phenobarbital µg/mL 9.52 7.42 – 11.6 24.8 20.9 – 28.6 47.8 41.4 – 54.2
Phenytoin µg/mL 5.87 4.44 – 7.30 12.9 10.4 – 15.4 25.5 21.0 – 30.0
Salicylate mg/dL 3.92 3.31 – 4.54 15.4 13.7 – 17.0 44.9 40.6 – 49.3
Theophylline µg/mL 4.53 3.69 – 5.38 14.9 12.8 – 16.9 27.3 23.8 – 30.9
Tobramycin µg/mL 1.00 0.725 – 1.28 2.70 2.27 – 3.13 6.16 5.41 – 6.90
Valproic Acid µg/mL 34.0 25.9 – 42.1 75.4 60.3 – 90.4 114 92.5 – 136
Vancomycin (VANC3) µg/mL 5.90 4.07 – 7.73 17.7 14.2 – 21.1 32.3 26.8 – 37.8
ROCHE COBAS INTEGRA
Acetaminophen (ACET2) µg/mL 8.50 6.30 – 10.7 29.6 24.6 – 34.7 93.0 79.0 – 107
Carbamazepine µg/mL 2.69 2.35 – 3.03 8.18 7.11 – 9.25 12.9 11.2 – 14.5
Gentamicin µg/mL 2.19 1.75 – 2.63 4.74 3.80 – 5.67 6.88 5.53 – 8.24
Lithium mEq/L 0.493 0.290 – 0.697 1.32 1.11 – 1.52 1.98 1.76 – 2.20
Phenobarbital µg/mL 9.23 8.07 – 10.4 23.0 20.6 – 25.4 45.1 40.7 – 49.6
Phenytoin µg/mL 6.21 5.55 – 6.87 12.9 11.1 – 14.7 24.2 20.5 – 28.0
Theophylline µg/mL 4.43 3.67 – 5.19 14.7 13.1 – 16.2 27.7 25.0 – 30.3
Valproic Acid µg/mL 31.7 25.2 – 38.2 70.3 56.9 – 83.6 108 87.8 – 128
Vancomycin µg/mL 6.69 4.85 – 8.52 18.5 15.6 – 21.4 33.8 29.5 – 38.2
ROCHE ELECSYS / E170 / COBAS e SYSTEMS
ACTH pg/mL 15.4 3.72 – 27.0 81.7 7.73 – 156 127 10.4 – 244
AFP ng/mL 18.2 13.3 – 23.1 105 81.6 – 128 223 175 – 272
Calcitonin pg/mL 46.5 29.5 – 63.6 142 95.3 – 189 502 343 – 662
CEA ng/mL 2.32 1.78 – 2.85 14.7 12.1 – 17.3 31.5 26.1 – 36.8
Cortisol µg/dL § § §
Cortisol (II) µg/dL 3.33 2.53 – 4.14 15.4 12.5 – 18.3 27.1 22.2 – 32.0
C-Peptide ng/mL 1.64 1.27 – 2.01 5.57 4.55 – 6.60 8.41 6.91 – 9.91
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 87.6 65.3 – 110 193 150 – 237 763 607 – 918
Digoxin (Ref. 11820796) restand. ng/mL 0.799 0.604 – 0.995 2.00 1.65 – 2.35 3.72 3.15 – 4.28
Estradiol (III) pg/mL 105 80.3 – 129 188 155 – 222 361 308 – 414
Ferritin ng/mL 80.8 65.5 – 96.1 198 158 – 238 474 386 – 563
Folate (cobas e801) ng/mL 2.79 <2.00 – 3.96 7.31 5.27 – 9.34 13.3 10.1 – 16.5
Folate (III) (E170/e601/e602/e411) (Ref. 07559992) restand. ng/mL 2.98 <2.00 – 4.18 7.79 5.64 – 9.93 13.6 10.3 – 16.9
Follicle Stimulating Hormone (FSH) mIU/mL 4.69 3.81 – 5.58 20.2 16.7 – 23.8 39.3 32.3 – 46.2
hCG (+ ß) mIU/mL 5.90 4.63 – 7.16 22.6 18.4 – 26.8 246 210 – 282
hCG (STAT) mIU/mL 4.72 3.69 – 5.75 20.5 16.8 – 24.3 205 169 – 240
Human Growth Hormone (hGH) ng/mL 3.66 2.44 – 4.88 8.58 6.92 – 10.2 16.4 13.9 – 18.9
Immunoglobulin E (IgE) ng/mL 969 788 – 1150 241 145 – 337 302 200 – 404
Insulin µIU/mL 19.3 15.8 – 22.8 65.8 55.2 – 76.4 228 196 – 260
Luteinizing Hormone (LH) mIU/mL 1.77 1.40 – 2.15 21.4 18.1 – 24.7 71.9 61.2 – 82.6

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (continued)
Progesterone ng/mL § § §
Progesterone (III) ng/mL 0.714 0.426 – 1.00 11.1 9.19 – 13.0 30.0 25.2 – 34.8
Prolactin ng/mL 8.58 6.39 – 10.8 23.7 17.7 – 29.6 54.5 41.8 – 67.3
Prostate Specific Antigen, Free (fPSA) (Cobas e411/e601/602) (Ref. Cat.
08828601) ng/mL 0.268 0.216 – 0.320 1.82 1.54 – 2.09 11.0 9.44 – 12.6
Prostate Specific Antigen, Free (fPSA) (Cobas e801) (Ref. Cat. 08828610) ng/mL 0.285 0.231 – 0.339 1.88 1.60 – 2.16 11.4 9.73 – 13.0
Prostate Specific Antigen, Total (e411/e601/602) (tPSA) (Ref. Cat.
08791686/08791716) ng/mL 0.777 0.641 – 0.913 3.62 3.04 – 4.19 21.7 18.4 – 25.1
Prostate specific Antigen, Total (tPSA) (Cobas e801) (Ref. Cat. 08791732) ng/mL 0.743 0.612 – 0.874 3.47 2.92 – 4.02 20.9 17.6 – 24.1
PSA (Free) ng/mL 0.282 0.228 – 0.336 1.88 1.60 – 2.16 11.6 9.89 – 13.2
PSA (Total) ng/mL 0.775 0.639 – 0.911 3.59 3.02 – 4.15 21.6 18.2 – 24.9
T3 Total ng/mL 0.996 0.751 – 1.24 2.20 1.73 – 2.68 3.58 2.84 – 4.32
T3 Uptake/T-Uptake TBI 0.976 0.848 – 1.10 0.626 0.459 – 0.794 0.277 <0.200 – 0.481
T3 (Free) pg/mL § § §
T3 (Free) (III) pg/mL 2.83 2.32 – 3.34 8.31 7.09 – 9.52 15.3 13.2 – 17.4
T4 Total µg/dL 5.65 4.41 – 6.89 9.92 7.82 – 12.0 13.9 11.0 – 16.7
T4 (Free) (II) ng/dL 1.11 0.984 – 1.23 2.78 2.28 – 3.28 5.17 4.13 – 6.20
T4 (Free) (III) ng/dL 1.13 1.00 – 1.26 2.88 2.36 – 3.40 5.56 4.44 – 6.67
Testosterone (II) ng/mL 1.63 1.20 – 2.05 4.37 3.51 – 5.22 9.60 7.91 – 11.3
Thyroid Stimulating Hormone (TSH) µIU/mL 0.493 0.358 – 0.629 5.36 4.08 – 6.65 36.6 27.9 – 45.2
Thyroid Stimulating Hormone (TSH) (Ref. 08429324/08443432) µIU/mL 0.520 0.430 – 0.610 5.53 4.22 – 6.84 38.5 29.5 – 47.5
Vitamin B12 (II) (E170/e601/e602) pg/mL 401 314 – 489 592 484 – 701 811 678 – 943
Vitamin B12 (II) (e411) pg/mL 383 297 – 468 561 456 – 666 816 683 – 949
Vitamin B12 (E170/e601/e602) pg/mL § § §
Vitamin B12 (II) (cobas e801) pg/mL 376 291 – 461 552 448 – 656 782 653 – 912
ROCHE HITACHI / MODULAR
Iron µg/dL 108 97.0 – 118 74.7 65.6 – 83.8 73.7 64.7 – 82.8
Phenobarbital µg/mL 9.52 7.42 – 11.6 24.8 20.9 – 28.6 47.8 41.4 – 54.2
Phenytoin µg/mL 5.87 4.44 – 7.30 12.9 10.4 – 15.4 25.5 21.0 – 30.0
Theophylline µg/mL 4.53 3.69 – 5.38 14.9 12.8 – 16.9 27.3 23.8 – 30.9
Tobramycin µg/mL 1.00 0.725 – 1.28 2.70 2.27 – 3.13 6.16 5.41 – 6.90
Valproic Acid µg/mL 34.0 25.9 – 42.1 75.4 60.3 – 90.4 114 92.5 – 136
SIEMENS ADVIA CENTAUR CP
AFP ng/mL 20.9 15.6 – 26.1 109 84.8 – 134 224 175 – 274
Androstenedione ng/mL 0.537 <0.300 – 0.840 1.19 0.844 – 1.53 2.07 1.61 – 2.54
Carbamazepine (CARB) µg/mL 2.69 1.51 – 3.87 7.55 4.94 – 10.2 11.6 7.77 – 15.5
CEA ng/mL 2.18 1.13 – 3.24 17.1 12.6 – 21.5 41.5 31.4 – 51.5
Cortisol (COR) µg/dL 3.12 1.81 – 4.43 16.9 11.9 – 21.9 28.9 20.7 – 37.1
C-Peptide (CpS) ng/mL 1.07 0.671 – 1.47 4.08 2.99 – 5.16 5.91 4.40 – 7.41
C-Peptide (CpS) (Rgt lots 206 & calibrator lot 08 & higher) ng/mL 1.14 0.741 – 1.54 4.30 3.21 – 5.39 6.44 4.94 – 7.94
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 58.3 45.8 – 70.7 135 112 – 158 463 386 – 539
Digoxin (DIG) ng/mL 0.826 0.623 – 1.03 2.08 1.66 – 2.51 3.97 3.27 – 4.68
Estradiol (eE2) pg/mL 111 71.3 – 150 252 183 – 321 650 497 – 802
Ferritin (FER) ng/mL 49.5 34.0 – 64.9 145 100 – 190 374 258 – 489
Folate (FOL) ng/mL 3.52 1.94 – 5.10 8.21 4.68 – 11.7 14.2 8.18 – 20.2
Follicle Stimulating Hormone (FSH) mIU/mL 5.25 3.80 – 6.70 25.3 19.1 – 31.4 51.4 39.1 – 63.8
Gentamicin (GENT) µg/mL 1.59 0.967 – 2.22 3.45 2.41 – 4.50 5.64 3.85 – 7.43
hCG (ThCG) mIU/mL 8.80 5.98 – 11.6 30.0 23.1 – 36.9 239 201 – 276
Immunoglobulin E (IgE) (tIgE) IU/mL 389 275 – 504 76.2 50.2 – 102 96.5 64.8 – 128
Insulin (IRI) µIU/mL 17.9 11.7 – 24.1 57.2 41.5 – 72.9 205 153 – 257
Luteinizing Hormone (LH) mIU/mL 1.49 0.972 – 2.00 22.1 17.3 – 26.8 73.3 59.0 – 87.6
Phenobarbital (PHNB) µg/mL 12.2 8.45 – 15.9 29.1 19.2 – 38.9 58.3 37.9 – 78.7
Phenytoin (PHTN) µg/mL 6.88 4.72 – 9.03 15.1 10.5 – 19.7 29.8 20.5 – 39.1
Progesterone (PRGE) ng/mL 0.883 0.415 – 1.35 9.20 6.90 – 11.5 23.2 17.8 – 28.6
Prolactin (PRL) ng/mL 6.00 4.58 – 7.43 14.7 11.0 – 18.5 35.0 26.0 – 44.1
PSA (Total) (PSA) ng/mL 0.678 0.534 – 0.821 3.02 2.30 – 3.75 19.7 14.9 – 24.6

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
PSA, Complexed (cPSA) ng/mL 0.380 0.298 – 0.461 1.02 0.737 – 1.30 6.08 4.20 – 7.95
T3 (Free) (FT3) pg/mL 2.86 2.43 – 3.29 7.79 6.73 – 8.84 12.7 11.2 – 14.2
T3 (Total) (T3) ng/mL 0.858 0.592 – 1.12 2.31 1.60 – 3.03 3.87 2.68 – 5.07
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.14 0.931 – 1.35 1.56 1.28 – 1.84 1.76 1.44 – 2.07
T4 (Free) (FT4) ng/dL 0.958 0.783 – 1.13 2.27 1.87 – 2.68 4.08 3.36 – 4.80
T4 (Total) (T4) µg/dL 6.39 4.69 – 8.08 13.8 10.6 – 17.1 20.7 16.4 – 25.1
Testosterone II (TSTII) ng/dL 154 92.8 – 215 391 272 – 509 795 578 – 1012
Theophylline (THEO2) µg/mL 4.11 2.29 – 5.94 13.7 10.0 – 17.3 25.8 19.5 – 32.1
Thyroid Stimulating Hormone (TSH) µIU/mL 0.513 0.420 – 0.606 5.66 4.46 – 6.87 39.0 30.8 – 47.2
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.355 0.289 – 0.421 4.30 3.39 – 5.20 30.1 23.6 – 36.6
Valproic Acid (VALP) µg/mL 34.6 26.8 – 42.4 75.3 60.4 – 90.1 112 90.4 – 133
Vancomycin (VANC) µg/mL 5.18 2.90 – 7.46 16.6 11.9 – 21.2 29.7 22.8 – 36.5
Vitamin B12 (VB12) pg/mL 371 253 – 489 559 403 – 714 879 659 – 1099
SIEMENS ADVIA CENTAUR SYSTEMS
AFP ng/mL 20.3 15.7 – 24.9 104 83.9 – 124 226 183 – 269
Androstenedione ng/mL 0.543 0.312 – 0.774 1.17 0.744 – 1.60 2.11 1.38 – 2.84
Carbamazepine (CARB) µg/mL 2.86 1.85 – 3.86 8.17 5.61 – 10.7 13.0 9.00 – 16.9
CEA ng/mL 2.03 1.30 – 2.77 18.3 14.4 – 22.2 41.6 33.1 – 50.1
Cortisol (COR) µg/dL 3.08 2.12 – 4.03 15.7 11.5 – 19.9 27.5 20.2 – 34.8
C-Peptide (CpS) ng/mL 1.09 0.640 – 1.55 4.14 2.86 – 5.43 6.52 4.58 – 8.45
C-Peptide (CpS) (Rgt lots 206 & calibrator lot 08 & higher) ng/mL 1.27 0.817 – 1.72 4.49 3.20 – 5.78 6.90 4.96 – 8.84
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 59.9 36.6 – 83.1 131 89.3 – 172 468 339 – 597
Digoxin (DIG) ng/mL 0.892 0.643 – 1.14 2.08 1.64 – 2.52 3.68 2.99 – 4.38
Estradiol (eE2) pg/mL 105 72.9 – 137 237 182 – 292 605 486 – 725
Ferritin (FER) ng/mL 53.5 42.5 – 64.5 172 132 – 213 437 331 – 542
Folate (FOL) ng/mL 3.19 1.71 – 4.67 7.67 4.66 – 10.7 12.8 8.10 – 17.4
Follicle Stimulating Hormone (FSH) mIU/mL 5.39 4.20 – 6.59 24.7 20.0 – 29.4 50.9 41.4 – 60.3
Gentamicin (GENT) µg/mL 1.79 1.25 – 2.32 3.98 2.92 – 5.04 7.01 5.10 – 8.91
hCG (ThCG) mIU/mL 8.16 4.79 – 11.5 29.3 22.9 – 35.8 234 202 – 265
Immunoglobulin E (IgE) (tIgE) IU/mL 406 316 – 496 90.0 72.0 – 108 112 88.6 – 134
Insulin (IRI) µIU/mL 18.2 13.4 – 23.0 61.0 46.1 – 75.8 217 165 – 268
Luteinizing Hormone (LH) mIU/mL 1.26 0.955 – 1.56 21.0 16.7 – 25.2 66.9 53.6 – 80.2
Phenobarbital (PHNB) µg/mL 11.6 8.43 – 14.7 29.9 22.0 – 37.8 59.5 44.0 – 75.0
Phenytoin (PHTN) µg/mL 5.79 3.84 – 7.75 13.5 9.92 – 17.1 30.4 22.5 – 38.2
Progesterone (PRGE) ng/mL 0.719 0.446 – 0.991 9.37 6.72 – 12.0 21.8 15.7 – 27.9
Prolactin (PRL) ng/mL 6.08 5.00 – 7.16 14.6 11.7 – 17.4 33.8 27.0 – 40.6
PSA (Total) (PSA) ng/mL 0.689 0.576 – 0.801 3.21 2.62 – 3.79 20.0 16.3 – 23.7
PSA, Complexed (cPSA) ng/mL 0.531 0.414 – 0.648 1.30 1.02 – 1.57 6.54 5.18 – 7.90
T3 (Free) (FT3) pg/mL 2.81 2.07 – 3.56 7.58 5.74 – 9.43 12.5 9.48 – 15.4
T3 (Total) (T3) ng/mL 0.875 0.615 – 1.14 2.30 1.80 – 2.79 3.73 2.99 – 4.47
T3 Uptake/T Uptake (TUp) (Unit) T Uptake Unit 1.12 0.910 – 1.33 1.45 1.19 – 1.71 1.63 1.34 – 1.92
T4 (Free) (FT4) ng/dL 0.892 0.675 – 1.11 2.12 1.64 – 2.59 3.77 2.94 – 4.59
T4 (Total) (T4) µg/dL 5.58 4.21 – 6.96 11.8 9.09 – 14.4 17.2 13.4 – 21.0
Testosterone (TSTII) ng/dL 158 104 – 212 402 272 – 532 800 546 – 1053
Theophylline (THEO2) µg/mL 4.50 2.78 – 6.22 14.1 10.3 – 17.9 25.9 19.5 – 32.3
Thyroid Stimulating Hormone (TSH) µIU/mL 0.529 0.362 – 0.696 5.89 4.42 – 7.36 41.3 31.9 – 50.7
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.376 0.246 – 0.506 4.44 3.32 – 5.56 31.9 24.1 – 39.7
Valproic Acid (VALP) µg/mL 33.8 27.5 – 40.0 72.1 59.7 – 84.5 108 89.8 – 126
Vancomycin (VANC) µg/mL 5.09 3.44 – 6.74 14.3 10.7 – 17.8 25.8 19.9 – 31.7
Vitamin B12 (VB12) pg/mL 383 267 – 499 564 409 – 718 895 670 – 1120
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (ACET) mg/dL 1.09 0.783 – 1.39 3.39 2.80 – 3.97 10.6 9.11 – 12.1
Carbamazepine (CARB_2) µg/mL 2.17 1.18 – 3.16 7.75 5.89 – 9.61 12.3 9.71 – 15.0
Digoxin (DIG) ng/mL 0.738 0.455 – 1.02 1.84 1.34 – 2.34 3.48 2.69 – 4.27
Ferritin (FRT) ng/mL 62.7 51.1 – 74.4 146 123 – 168 339 286 – 391

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CHEMISTRY SYSTEMS (continued)
Gentamicin (GENT_2) µg/mL 2.33 1.70 – 2.97 4.70 3.74 – 5.66 6.78 5.50 – 8.06
Immunoglobulin A (IgA) (IGA_2) mg/dL 185 154 – 217 153 125 – 180 163 135 – 192
Immunoglobulin G (IgG) (IGG_2) mg/dL 816 670 – 962 721 589 – 852 766 628 – 905
Immunoglobulin M (IgM) (IGM_2) mg/dL 63.4 53.2 – 73.5 61.6 51.7 – 71.6 65.3 55.0 – 75.5
Iron (IRON_2) µg/dL 110 83.7 – 136 73.7 45.7 – 102 72.7 44.7 – 101
Lithium (LITH) mEq/L 0.511 0.380 – 0.643 1.30 1.09 – 1.50 1.82 1.57 – 2.08
Phenobarbital (PHNB_2) µg/mL 9.52 7.26 – 11.8 24.8 19.2 – 30.3 50.2 38.9 – 61.4
Phenytoin (PHNY_2) µg/mL 5.50 3.51 – 7.49 13.1 9.15 – 17.0 26.3 18.8 – 33.7
Salicylate (SAL) mg/dL 4.52 2.50 – 6.53 17.7 14.8 – 20.6 51.8 46.5 – 57.0
Theophylline (THEO_2) µg/mL 4.40 3.00 – 5.80 14.5 10.7 – 18.3 27.8 20.7 – 34.9
Tobramycin (TOB_2) µg/mL 0.917 0.723 – 1.11 2.62 2.20 – 3.04 5.72 4.84 – 6.59
Valproic Acid (VPA_2) µg/mL 35.5 28.5 – 42.6 74.9 59.8 – 90.0 108 86.0 – 131
Vancomycin (VANC_2) µg/mL § § §
SIEMENS BN SERIES NEPHELOMETERS
Immunoglobulin A (IgA) mg/dL 198 175 – 222 158 137 – 179 169 147 – 191
Immunoglobulin E (IgE) IU/mL 391 284 – 498 84.5 63.0 – 106 112 82.9 – 141
Immunoglobulin G (IgG) mg/dL 869 697 – 1041 761 615 – 906 817 657 – 976
Immunoglobulin M (IgM) mg/dL 77.5 59.5 – 95.6 71.4 55.1 – 87.7 74.5 57.3 – 91.7
SIEMENS DIMENSION SERIES
Acetaminophen (ACTM) µg/mL 10.2 7.01 – 13.5 38.4 30.6 – 46.3 116 95.6 – 137
Carbamazepine (CRBM) µg/mL 2.62 2.03 – 3.20 7.50 6.32 – 8.68 11.6 9.95 – 13.3
Digoxin (DGNA) ng/mL 0.833 0.611 – 1.06 2.01 1.68 – 2.33 3.48 3.03 – 3.93
Ferritin (FERR) ng/mL 78.0 62.7 – 93.2 201 165 – 237 477 404 – 549
Folate (FOLA) (EXL LOCI MODULE) (RF644) ng/mL 2.87 1.96 – 3.79 6.53 4.74 – 8.33 11.3 8.35 – 14.2
Gentamicin (GENT) µg/mL 2.05 1.59 – 2.51 4.79 4.08 – 5.50 7.36 6.41 – 8.32
hCG mIU/mL 8.05 6.04 – 10.1 22.1 17.9 – 26.3 287 242 – 332
Immunoglobulin A (IgA) mg/dL 187 162 – 211 151 128 – 174 160 137 – 184
Immunoglobulin G (IgG) mg/dL 893 775 – 1010 735 637 – 834 768 664 – 871
Immunoglobulin M (IgM) mg/dL 63.7 48.3 – 79.1 64.2 48.8 – 79.6 65.3 49.7 – 80.9
Iron µg/dL 108 95.4 – 120 73.8 63.6 – 84.0 71.6 61.5 – 81.6
Iron (TIBC) µg/dL 273 229 – 317 236 195 – 276 241 200 – 282
Lithium (LI) mmol/L 0.389 0.235 – 0.544 1.15 0.959 – 1.34 1.66 1.45 – 1.87
Phenobarbital (PHNO) µg/mL 9.78 6.29 – 13.3 24.5 19.0 – 30.0 47.0 38.4 – 55.6
Phenytoin (PTN) µg/mL 6.54 4.67 – 8.41 13.7 11.0 – 16.5 27.2 22.8 – 31.6
PSA (Free) (FPSA) ng/mL 0.270 0.182 – 0.358 1.89 1.50 – 2.29 12.7 10.2 – 15.3
PSA (Total) (TPSA) ng/mL 0.762 0.522 – 1.00 3.37 2.72 – 4.02 21.3 17.8 – 24.7
Salicylate (SAL) mg/dL 4.75 3.67 – 5.84 16.3 13.5 – 19.2 43.8 36.7 – 50.8
T3 (Free) (FT3) pg/mL 2.27 1.65 – 2.90 8.56 6.49 – 10.6 16.7 13.5 – 19.9
T3 Uptake/T Uptake (%, TU) % Uptake § § §
T4 (Free) (EXL LOCI Module) ng/dL 0.958 0.739 – 1.18 2.45 2.03 – 2.86 6.05 5.14 – 6.97
T4 (Free) (Heterogeneous Module) ng/dL § § §
T4 (Total) (T4) µg/dL § § §
Theophylline (THEO) µg/mL 4.58 3.64 – 5.51 15.2 12.4 – 17.9 28.9 23.8 – 33.9
Thyroid Stimulating Hormone (TSH) µIU/mL 0.365 0.234 – 0.496 4.57 3.40 – 5.74 32.4 24.3 – 40.4
Thyroid Stimulating Hormone (TSH) (EXL LOCI Module) (TSHL) µIU/mL 0.406 0.332 – 0.480 5.02 3.95 – 6.08 40.0 30.8 – 49.2
Tobramycin (TOBR) µg/mL 0.517 0.319 – 0.714 2.18 1.85 – 2.52 5.37 4.76 – 5.97
Valproic Acid (VALP) µg/mL 32.4 26.4 – 38.5 69.4 59.2 – 79.6 100 86.4 – 114
Vancomycin (VANC) µg/mL 6.02 4.61 – 7.43 17.3 14.4 – 20.2 30.1 25.5 – 34.7
Vitamin B12 (VB12) (EXL LOCI MODULE) (RF642) pg/mL 368 289 – 448 532 439 – 625 791 677 – 905
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen (ACTM) µg/mL 13.6 10.0 – 17.2 42.4 36.9 – 48.0 122 111 – 133
AFP ng/mL 16.6 13.4 – 19.7 92.1 79.8 – 104 200 175 – 226
Amikacin µg/mL 4.67 3.89 – 5.44 13.6 10.9 – 16.3 23.9 18.3 – 29.5
Caffeine µg/mL 1.97 1.24 – 2.70 7.11 5.25 – 8.97 14.5 11.0 – 18.0
Carbamazepine (CRBM) µg/mL 2.64 2.17 – 3.12 7.82 6.72 – 8.92 12.2 10.6 – 13.8

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS (continued)
CEA ng/mL 1.94 1.63 – 2.25 16.8 14.8 – 18.8 38.0 33.6 – 42.4
Digoxin (DGXN) ng/mL 0.820 0.619 – 1.02 1.96 1.61 – 2.31 3.66 3.14 – 4.18
Estradiol pg/mL 97.3 75.0 – 120 211 179 – 243 440 389 – 491
Ferritin (FERR) ng/mL 57.5 50.3 – 64.7 165 142 – 188 408 349 – 467
Folate (FOL) ng/mL 2.48 1.65 – 3.31 5.98 4.54 – 7.43 10.1 7.95 – 12.3
Follicle Stimulating Hormone (FSH) mIU/mL 4.55 3.09 – 6.00 19.5 15.0 – 24.0 36.9 28.5 – 45.4
Gentamicin (GENT) µg/mL 2.08 1.65 – 2.52 4.93 4.19 – 5.68 7.43 6.42 – 8.45
hCG (Beta, BHCG) mIU/mL 7.98 5.80 – 10.2 21.3 17.2 – 25.3 265 237 – 294
Immunoglobulin A (IgA) mg/dL 196 172 – 221 158 135 – 181 168 143 – 192
Immunoglobulin E (IgE) IU/mL 384 337 – 431 87.3 72.8 – 102 112 94.5 – 129
Immunoglobulin G (IgG) mg/dL 882 775 – 989 762 662 – 861 814 715 – 914
Immunoglobulin M (IgM) mg/dL 76.9 65.7 – 88.1 68.6 58.5 – 78.6 72.3 61.8 – 82.9
Iron µg/dL 109 86.7 – 131 74.7 52.7 – 96.7 72.5 50.5 – 94.5
Iron (TIBC) µg/dL 279 234 – 324 248 207 – 289 251 209 – 293
Lidocaine (LIDO) µg/mL 1.51 1.21 – 1.82 3.81 3.30 – 4.32 6.69 5.92 – 7.46
Lithium (LITH) mmol/L 0.472 0.372 – 0.571 1.23 1.09 – 1.36 1.69 1.53 – 1.84
Luteinizing Hormone (LH) mIU/mL 1.43 0.837 – 2.02 21.8 16.4 – 27.2 83.4 62.7 – 104
N-Acetyl Procainamide (NAPA) µg/mL 1.51 0.956 – 2.06 4.16 3.36 – 4.96 8.64 7.27 – 10.0
Phenobarbital (PHNO) µg/mL 9.80 6.85 – 12.7 25.8 21.5 – 30.1 48.5 42.3 – 54.7
Phenytoin (PTN) µg/mL 6.52 5.03 – 8.00 14.6 12.2 – 17.1 27.6 23.6 – 31.5
Procainamide (PROC) µg/mL 2.09 1.54 – 2.65 8.90 7.40 – 10.4 15.0 12.6 – 17.3
Progesterone (PROG) ng/mL 0.849 0.682 – 1.02 9.04 8.00 – 10.1 23.4 20.8 – 26.0
Prolactin (PRL) ng/mL 6.14 5.12 – 7.16 18.4 15.4 – 21.3 44.6 37.2 – 52.0
PSA (Free) (FPSA) ng/mL 0.269 0.179 – 0.358 1.93 1.52 – 2.34 12.0 9.50 – 14.4
PSA (Total) (TPSA) ng/mL 0.711 0.568 – 0.853 3.25 2.69 – 3.81 20.3 16.9 – 23.6
Salicylate (SAL) mg/dL 5.05 3.32 – 6.78 16.7 14.1 – 19.3 44.5 39.7 – 49.3
T3 (Free) (FT3) pg/mL 2.29 1.64 – 2.93 8.30 6.77 – 9.82 15.9 13.8 – 17.9
T3 Uptake/T Uptake (%, TU) % Uptake 34.3 28.5 – 40.2 42.2 34.6 – 49.8 45.0 36.8 – 53.2
T4 (Free) (FT4) ng/dL 0.958 0.820 – 1.10 2.42 2.13 – 2.71 5.98 5.31 – 6.66
T4 (Total) (T4) µg/dL 7.23 5.00 – 9.45 13.0 10.4 – 15.6 18.1 15.2 – 21.1
Theophylline (THEO) µg/mL 4.22 3.37 – 5.07 14.7 12.4 – 17.0 27.5 23.5 – 31.5
Thyroid Stimulating Hormone (TSH) µIU/mL 0.389 0.315 – 0.462 4.74 3.90 – 5.58 35.9 29.5 – 42.2
Tobramycin (TOBR) µg/mL 0.568 <0.300 – 0.857 2.24 1.77 – 2.71 5.48 4.66 – 6.31
Valproic Acid (VALP) µg/mL 36.5 29.6 – 43.3 80.7 68.5 – 92.9 118 101 – 135
Vancomycin (VANC) µg/mL 5.93 4.28 – 7.57 17.4 14.4 – 20.5 29.8 25.2 – 34.4
Vitamin B12 (VB12) pg/mL 387 326 – 448 552 479 – 625 762 673 – 850
SIEMENS IMMULITE / IMMULITE 1000
AFP ng/mL 17.1 10.3 – 23.9 98.9 61.9 – 136 206 130 – 283
Androstenedione (2) ng/mL 1.08 0.606 – 1.56 2.98 1.99 – 3.97 6.01 4.87 – 7.15
CEA ng/mL 2.49 1.24 – 3.73 20.9 15.3 – 26.4 48.3 36.3 – 60.3
Cortisol µg/dL 2.86 1.59 – 4.13 16.5 11.7 – 21.4 26.6 19.1 – 34.1
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 58.2 36.0 – 80.5 122 79.5 – 165 484 326 – 643
Estradiol pg/mL 96.3 58.8 – 134 256 175 – 337 545 385 – 705
Estriol (Free) (UE3) ng/mL 1.37 0.701 – 2.03 4.93 3.28 – 6.57 >11.2
Ferritin ng/mL 62.2 47.0 – 77.3 146 105 – 186 352 249 – 455
Follicle Stimulating Hormone (FSH) mIU/mL 5.53 4.30 – 6.76 23.0 18.2 – 27.9 47.2 37.1 – 57.2
hCG mIU/mL 10.5 6.32 – 14.8 27.5 18.5 – 36.6 353 258 – 448
hCG (Turbo) mIU/mL 11.1 6.71 – 15.5 28.6 19.3 – 38.0 360 264 – 455
Human Growth Hormone (hGH) (LKGRH) ng/mL 3.39 2.38 – 4.40 7.82 5.91 – 9.74 15.6 12.1 – 19.2
Immunoglobulin E (IgE) (Rgt. Lots 401+) IU/mL 382 267 – 496 92.4 69.3 – 116 117 86.4 – 148
Luteinizing Hormone (LH) mIU/mL 1.56 1.12 – 2.00 22.4 17.4 – 27.4 72.1 56.2 – 88.0
Progesterone (LKPW1) ng/mL 0.690 0.358 – 1.02 9.48 6.45 – 12.5 26.6 18.7 – 34.6
Prolactin ng/mL 8.30 6.13 – 10.5 20.2 15.0 – 25.4 47.9 35.6 – 60.2
PSA (Free) ng/mL 0.225 0.121 – 0.328 1.67 1.22 – 2.12 9.47 7.16 – 11.8
PSA (Total) ng/mL 0.668 0.448 – 0.888 3.29 2.43 – 4.16 19.8 14.9 – 24.8

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE / IMMULITE 1000 (continued)
PSA (Total) (Gen. 3) ng/mL 0.553 0.361 – 0.745 2.41 1.76 – 3.05 17.3 13.0 – >20.0
T3 (Free) pg/mL 2.81 1.73 – 3.89 5.97 4.19 – 7.74 9.22 6.72 – 11.7
T3 (Total) ng/dL 64.3 <40.0 – 95.2 200 137 – 264 339 242 – 436
T3 Uptake/T Uptake % Uptake 29.1 23.9 – 34.2 38.1 30.8 – 45.4 45.2 36.2 – 54.2
T4 (Free) ng/dL 1.29 0.996 – 1.57 3.06 2.33 – 3.78 5.75 4.35 – >6.00
T4 (Total) µg/dL 5.37 3.45 – 7.30 10.9 7.80 – 14.1 15.4 11.3 – 19.6
Testosterone ng/dL 114 81.3 – 146 523 420 – 625 1535 1257 – >1600
Testosterone (Rgt. Lot 550 and higher) (2) ng/dL 120 85.5 – 155 475 381 – 569 1078 883 – 1273
Thyroglobulin (Tg) ng/mL >3.00 1.38 0.696 – 2.07 2.07 1.38 – 2.76
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.448 0.366 – 0.529 4.65 3.39 – 5.92 35.4 25.4 – 45.4
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.475 0.388 – 0.562 4.83 3.51 – 6.14 31.2 22.4 – 40.0
Vitamin B12 pg/mL 412 225 – 599 670 403 – 936 947 594 – >1200
SIEMENS IMMULITE 2000 / 2000 XPi
ACTH pg/mL 26.9 9.20 – 44.6 214 83.6 – 344 343 135 – 552
AFP ng/mL 16.7 11.6 – 21.7 91.5 61.1 – 122 198 132 – 265
Androstenedione ng/mL 0.947 0.562 – 1.33 3.16 2.03 – 4.29 6.13 3.99 – 8.26
Androstenedione (Rgt. Lots 450 and above) ng/mL 0.892 0.538 – 1.25 3.15 2.05 – 4.24 6.39 4.23 – 8.55
Calcitonin pg/mL 40.7 32.4 – 48.9 132 111 – 153 442 376 – 508
Carbamazepine µg/mL 2.28 1.67 – 2.90 6.85 5.37 – 8.32 10.8 8.61 – 13.1
CEA ng/mL 2.50 1.62 – 3.38 21.1 16.1 – 26.2 51.0 39.3 – 62.8
Cortisol µg/dL 2.68 1.74 – 3.63 14.9 11.1 – 18.6 25.4 19.2 – 31.6
Cortisol (Rgt. Lot 550 and above) µg/dL 2.76 1.80 – 3.72 14.9 11.1 – 18.6 25.4 19.2 – 31.6
C-Peptide ng/mL 1.19 0.829 – 1.55 5.17 3.91 – 6.42 8.19 6.25 – 10.1
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 51.2 33.5 – 69.0 116 81.5 – 150 508 370 – 645
Digoxin ng/mL 0.895 0.585 – 1.21 2.14 1.62 – 2.67 3.86 3.04 – 4.68
Estradiol pg/mL 102 67.3 – 137 264 196 – 332 590 455 – 725
Estriol (Free) ng/mL 1.18 0.665 – 1.70 4.75 3.36 – 6.15 11.5 8.45 – >12.0
Ferritin ng/mL 64.2 49.0 – 79.4 151 114 – 188 378 285 – 471
Folate ng/mL 3.64 2.46 – 4.81 8.50 5.55 – 11.5 17.2 11.8 – 22.6
Follicle Stimulating Hormone (FSH) mIU/mL 5.48 4.35 – 6.61 22.7 17.9 – 27.6 46.6 36.6 – 56.6
Gastrin pg/mL 106 63.2 – 149 563 368 – 758 871 574 – >1000
hCG mIU/mL 9.70 5.37 – 14.0 23.7 16.1 – 31.3 294 220 – 368
Human Growth Hormone (hGH) (L2KGRH/L5KGRH) ng/mL 3.61 2.81 – 4.41 8.20 6.46 – 9.94 14.9 11.8 – 17.9
IGF-1/Somatomedin C ng/mL 103 68.1 – 137 97.4 64.7 – 130 109 72.2 – 146
Immunoglobulin E (IgE) IU/mL 429 290 – 567 93.0 64.6 – 121 117 80.6 – 153
Luteinizing Hormone (LH) mIU/mL 1.43 0.994 – 1.86 19.3 14.4 – 24.2 61.8 46.3 – 77.3
Phenobarbital µg/mL 9.65 7.97 – 11.3 24.4 20.5 – 28.4 49.3 41.7 – 57.0
Phenytoin µg/mL 6.00 3.86 – 8.13 13.1 9.38 – 16.8 25.9 19.4 – 32.4
Progesterone ng/mL 0.642 0.376 – 0.908 7.50 5.36 – 9.63 20.9 15.0 – 26.7
Prolactin ng/mL 7.14 5.52 – 8.76 17.8 14.0 – 21.6 41.4 32.7 – 50.2
Prostatic Acid Phosphatase (PAP) ng/mL 1.35 1.00 – 1.70 23.7 18.1 – 29.3 49.5 37.9 – 61.1
PSA (Free) ng/mL 0.232 0.142 – 0.321 1.71 1.27 – 2.15 10.0 7.61 – 12.4
PSA (Total) ng/mL 0.662 0.323 – 1.00 3.16 2.17 – 4.14 20.2 14.7 – 25.8
T3 (Free) pg/mL 2.73 1.67 – 3.79 6.11 4.51 – 7.72 9.64 7.46 – 11.8
T3 (Total) ng/dL 69.3 45.1 – 93.5 209 161 – 257 352 279 – 425
T3 Uptake/T Uptake % Uptake 28.1 23.4 – 32.8 34.5 28.2 – 40.9 40.0 31.9 – 48.0
T4 (Free) (L2KFT4/L5KFT4) ng/dL 1.26 1.03 – 1.48 2.99 2.40 – 3.59 5.39 4.29 – >6.00
T4 (Total) µg/dL 5.31 3.78 – 6.83 10.1 7.50 – 12.6 15.0 11.3 – 18.6
Testosterone ng/dL 130 77.2 – 182 493 325 – 661 1113 747 – 1479
Theophylline µg/mL 4.06 2.61 – 5.51 14.3 10.3 – 18.3 25.0 18.3 – 31.6
Thyroglobulin (Tg) ng/mL 3.53 2.28 – 4.77 1.43 0.535 – 2.32 2.03 0.923 – 3.14
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.429 0.334 – 0.523 4.72 3.52 – 5.92 31.7 23.3 – 40.2
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.502 0.408 – 0.596 5.33 3.97 – 6.69 34.0 25.0 – 43.0
Thyroxine Binding Globulin (TBG) µg/mL 15.5 11.0 – 19.9 14.2 9.56 – 18.9 14.1 9.43 – 18.8
Valproic Acid µg/mL 30.2 24.1 – 36.3 72.8 59.7 – 86.0 115 94.6 – 135

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

INSTRUMENT (1)
Level 1 - 40411 Level 2 - 40412 Level 3 - 40413
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE 2000 / 2000 XPi (continued)
Vitamin B12 pg/mL 354 255 – 453 622 437 – 807 876 609 – >1000
TOSOH AIA SYSTEMS (2)
25-Hydroxy Vitamin D (AIA-PACK) ng/mL 14.9 10.4 – 19.4 26.3 18.4 – 34.2 22.6 15.8 – 29.4
ACTH (ST AIA-PACK) pg/mL 20.7 14.5 – 26.9 109 76.0 – 141 190 133 – 247
AFP (ST AIA-PACK) ng/mL 17.0 11.9 – 22.1 93.8 65.7 – 122 196 137 – 255
CEA (ST AIA-PACK) ng/mL 3.00 2.10 – 3.90 19.7 13.8 – 25.6 43.1 30.2 – 56.0
Cortisol (ST AIA-PACK) µg/dL 3.40 2.40 – 4.40 17.6 12.3 – 22.9 29.9 20.9 – 38.9
C-Peptide (II, ST AIA-PACK) ng/mL 1.35 0.950 – 1.76 5.26 3.68 – 6.84 8.37 5.86 – 10.9
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (ST AIA-PACK) µg/dL 70.6 49.4 – 91.7 158 111 – 205 593 415 – 771
Estradiol (REF E2-025274) pg/mL 269 188 – 349 563 394 – 732 1218 853 – 1584
Estradiol (REF HSE2-025225) pg/mL 98.0 68.6 – 127 217 152 – 282 418 293 – 544
Ferritin (ST AIA-PACK) ng/mL 52.7 36.9 – 68.5 129 90.1 – 167 321 225 – 418
Folate (AIA-PACK) ng/mL 4.84 2.74 – 6.94 9.79 5.53 – 14.1 15.5 10.4 – >20.0
Follicle Stimulating Hormone (FSH) (ST AIA-PACK) mIU/mL 6.40 4.50 – 8.30 25.0 17.5 – 32.5 43.2 30.2 – 56.2
hCG (Total Beta, ST AIA-PACK) mIU/mL 8.80 6.20 – 11.4 24.5 17.2 – 31.9 273 191 – 355
Human Growth Hormone (hGH) (ST AIA-PACK) ng/mL 3.62 2.53 – 4.71 9.26 6.48 – 12.0 17.7 12.4 – 23.0
Immunoglobulin E (IgE) (II, ST AIA-PACK) IU/mL 359 252 – 467 82.7 57.9 – 108 106 73.9 – 137
Insulin (IRI, ST AIA-PACK) µIU/mL 18.1 12.7 – 23.5 60.4 42.3 – 78.5 197 138 – 256
Luteinizing Hormone (LH) (II, ST AIA-PACK) mIU/mL 1.30 0.900 – 1.70 18.7 13.1 – 24.3 70.7 49.5 – 91.9
Progesterone (ST AIA-PACK, PROGII) ng/mL 0.310 0.220 – 0.400 12.1 8.48 – 15.8 32.6 22.8 – >40.0
Progesterone (ST AIA-PACK, PROGIII) (Cal Lot G33CC359) ng/mL 0.550 0.390 – 0.720 13.6 9.52 – 17.7 34.6 24.2 – >40.0
Prolactin ng/mL 1.10 <1.00 – 1.40 5.50 3.90 – 7.20 6.10 4.30 – 7.90
Prostatic Acid Phosphatase (PAP) (ST AIA-PACK) ng/mL 1.30 0.900 – 1.70 20.4 14.3 – 26.5 37.4 26.2 – >40.0
PSA (Total) (ST AIA-PACK) ng/mL 0.730 0.510 – 0.950 3.18 2.23 – 4.13 18.9 13.2 – 24.5
T3 (Free) (ST AIA-PACK) pg/mL 2.74 1.92 – 3.56 9.75 6.83 – 12.7 23.0 16.1 – >25.0
T3 (Total) (ST AIA-PACK) ng/mL 0.900 0.630 – 1.17 2.04 1.43 – 2.65 3.29 2.30 – 4.28
T3 Uptake/T Uptake (ST AIA-PACK) % Uptake 33.8 23.7 – 43.9 43.5 30.5 – 56.6 48.6 34.0 – >60.0
T4 (Free) (ST AIA-PACK) ng/dL 1.07 0.750 – 1.39 2.82 1.97 – 3.67 5.46 3.82 – 7.10
T4 (Total) (ST AIA-PACK) µg/dL 5.60 3.90 – 7.30 10.2 7.10 – 13.3 14.7 10.3 – 19.1
Testosterone (ST AIA-PACK) ng/dL 114 79.7 – 148 507 355 – 659 1381 967 – 1795
Thyroid Stimulating Hormone (TSH) (ST AIA-PACK) µIU/mL 0.420 0.290 – 0.550 4.88 3.42 – 6.34 32.5 22.7 – 42.2
Thyroid Stimulating Hormone (TSH) (TSH3G, AIA-PACK) µIU/mL 0.380 0.270 – 0.490 4.62 3.23 – 6.01 31.5 22.0 – 40.9
Vitamin B12 (AIA-PACK) pg/mL 456 319 – 593 772 540 – 1004 1058 741 – 1375

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.
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.

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