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Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40341
371 Level 1 12 x 5 mL
2019-11-30 40340 Level 2 40342
372 Level 2 12 x 5 mL 0459
Level 3 40343
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

http://www.myeinserts.com/40340

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 by FDA
For customers in Germany: Quality control materials are required for assessment accepted methods and found non-reactive for Hepatitis B Surface Antigen
of laboratory performance as described in the “Guideline for Quality Assurance (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2. This product
of Medical Laboratory Examinations following the German Medical Association” may also contain other human source materials for which there are no approved
(Rili-BÄK regulation). tests. In accordance with good laboratory practice, all human source material
REAGENT should be considered potentially infectious and handled with the same
This product is prepared from human serum with added chemicals, constituents precautions used with patient specimens.
of human and animal origin, therapeutic drugs and stabilizers. This product is Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
provided in lyophilized form for increased stability. SPECIFIC PERFORMANCE CHARACTERISTICS
STORAGE AND STABILITY This product is a freeze-dried product manufactured under rigid quality control
This product will be stable until the expiration date when stored standards. To obtain consistent assay values, the control requires proper storage
unopened at 2 to 8°C. and handling as described.
Reconstituted and Refrigerated: After reconstituting and storing tightly capped ASSIGNMENT OF VALUES
at 2 to 8°C, this product will be stable as follows: The mean values and corresponding ±3SD ranges in the Assignment of Values
- All analytes: 7 days Data Charts (available separately) were derived from replicate analyses and are
Except: specific for this lot of product. Data from Unity™ Interlaboratory Program are
- Folate and PSA (Total): 3 days at 2 to 8°C included in the determination of some ranges. The tests listed were performed
- C-Peptide: 1 day at 2 to 8°C by the manufacturer and/or independent laboratories using manufacturer
- ACTH, Calcitonin, Gastrin and PSA (Free): Assay immediately supported reagents and a representative sampling of this lot of product. It is
after reconstitution. recommended that each laboratory establish its own acceptable ranges and use
Reconstituted and Frozen: When reconstituted and stored tightly capped those provided only as guides. Laboratory established ranges may vary from
at -20 to -70°C, this product will be stable as follows: those listed during the life of this control. [Customers in Germany have to follow
- All analytes: 20 days the requirements as described in the Rili-BÄK regulation.] Variations over time
Except: and between laboratories may be caused by differences in laboratory technique,
- ACTH, Aldosterone, Calcitonin and C-Peptide: No frozen stability provided. instrumentation and reagents, or by manufacturer test method modifications.
Once thawed, do not refreeze this product. Discard the remaining material.
This product is shipped under ambient conditions. Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
PROCEDURE holding more than 2 billion QC data points from thousands of laboratories.
This product should be treated the same as patient specimens and run in INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
accordance with the instructions accompanying the instrument, kit, or reagent The Data Charts are available through the Internet, at
being used. www.myeinserts.com/40340. Follow the directions at the website to receive
Using a volumetric pipet or equivalent, reconstitute each vial with 5.0 mL of email notifications of insert updates. Alternate methods for receiving data charts
distilled or deionized water. Replace the stopper and allow this product to stand are available by contacting your local Bio-Rad Laboratories Office.
for approximately 15 minutes swirling occasionally. IMPORTANT PRODUCT INFORMATION
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, Significant changes are highlighted!
promptly replace the stopper and return to 2 to 8°C storage. For this lot of control - No claims are made for expected values or stability of
Dispose of any discarded materials in accordance with the requirements of your the following analytes: Dehydroepiandrosterone (DHEA) and Glucagon.
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 • 2017-01 • 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.
★ See Important Product Information section.

LEXICON

Reconstitute with

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© 2017 Bio-Rad Laboratories Inc. Printed in the USA Page 2 English • 2017-01 • 1536-00
Lyphochek® Immunoassay Plus Control, Levels 1, 2 and 3

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
11-DEOXYCORTISOL (2)
DIAsource RIA CT ng/mL 0.848 0.701 – 0.995 3.48 2.90 – 4.07 4.90 4.15 – 5.66
17-ALPHA-HYDROXYPROGESTERONE (2)
Beckman Coulter RIA (IM1452) ng/mL 0.450 0.330 – 0.560 1.58 1.17 – 1.99 4.00 2.95 – 5.05
Diagnostics Biochem Canada ELISA ng/mL 0.175 0.126 – 0.223 1.85 1.50 – 2.21 5.18 4.32 – 6.04
DiaMetra ELISA ng/mL 0.590 0.320 – 0.870 2.87 1.94 – 3.80 5.95 4.08 – 7.83
DIAsource RIA CT ng/mL 0.821 0.575 – 1.07 2.31 1.78 – 2.83 5.75 4.34 – 7.16
DRG ELISA (EIA-1292) ng/mL 0.560 0.310 – 0.810 2.27 1.25 – 3.30 5.82 3.20 – 8.44
IBL ELISA ng/mL 0.460 0.250 – 0.670 1.99 1.10 – 2.89 6.02 3.31 – 8.73
Monobind AccuBind ELISA ng/mL 0.980 0.650 – 1.30 3.42 2.29 – 4.55 8.00 5.36 – >10.0
Monobind AccuLite CLIA ng/mL 0.940 0.630 – 1.25 3.39 2.27 – 4.50 7.77 5.20 – >10.0
MP BioMedicals ImmuChem CT RIA ng/mL 0.460 0.340 – 0.580 1.70 1.30 – 2.10 4.60 3.90 – 5.30
MP BioMedicals ImmuChem DA RIA ng/mL 0.630 0.510 – 0.760 3.00 2.50 – 3.50 10.5 8.10 – 12.9
ACETAMINOPHEN
Cambridge Life Sciences Paracetamol (K8003) (2) µg/mL 9.37 6.65 – 12.2 34.4 27.5 – 41.2 107 85.3 – 128
Emit µg/mL <10.0 – 12.5 35.0 28.3 – 41.7 107 88.2 – 126
SEKURE (Sekisui Diagnostics) (2) µg/mL 10.0 7.00 – 13.0 34.0 25.0 – 43.0 106 79.0 – 133
ACTH (2)
Beckman Coulter IRMA (IM2030) pg/mL 34.3 26.6 – 42.0 50.9 34.4 – 67.4 183 127 – 240
Biomerica ELISA pg/mL 44.5 40.1 – 48.9 79.2 57.9 – 101 215 186 – 244
BRAHMS Diagnostica RIA pg/mL 39.0 29.0 – 49.0 117 74.0 – 160 237 187 – 287
Cisbio Bioassays pg/mL 139 111 – 167 390 310 – 470 880 700 – 1060
AFP (2)
Beckman Coulter IRMA (IM1441) ng/mL 19.0 14.6 – 23.4 105 87.5 – 123 234 199 – 267
Beckman Coulter Screening IRMA (A37404) ng/mL 21.1 16.7 – 25.5 117 91.4 – 142 >271
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 11.5 7.59 – 15.3 59.2 39.4 – 78.9 165 110 – 220
Cisbio Bioassays ng/mL 16.8 13.4 – 20.2 83.0 66.0 – 100 183 146 – 220
Cisbio Bioassays RIA-gnost IU/mL 14.7 11.8 – 17.6 68.0 54.0 – 82.0 129 103 – 155
DiaMetra ELISA ng/mL 12.2 8.01 – 16.3 50.2 31.6 – 68.9 80.7 52.2 – 109
DRG ELISA (EIA-1468) ng/mL 22.8 15.0 – 30.5 127 83.9 – 170 >193
Fortress Diagnostics ng/mL 14.2 11.4 – 17.1 86.2 69.0 – 103 177 142 – 213
HUMAN ELISA ng/mL 13.4 8.97 – 17.8 79.0 52.9 – 105 186 125 – 248
IBL ELISA IU/mL
Institute of Isotopes IRMA IU/mL 12.6 10.1 – 15.1 68.6 54.8 – 82.3 150 120 – 180
Monobind AccuBind ELISA ng/mL 13.4 8.97 – 17.8 79.0 52.9 – 105 186 125 – 248
Monobind AccuLite CLIA ng/mL 11.2 7.53 – 15.0 71.0 47.6 – 94.5 180 121 – 239
ALDOSTERONE (2)
Beckman Coulter RIA (DSL8600) pg/mL 130 79.3 – 180 321 243 – 400 860 612 – 1107
Beckman Coulter RIA (IM1664) pg/mL 28.6 14.6 – 42.6 138 92.2 – 183 418 296 – 539
Cisbio Bioassays pg/mL 73.0 55.0 – 91.0 97.0 77.0 – 117 261 212 – 310
DiaMetra ELISA pg/mL 129 58.6 – 199 447 293 – 600 934 599 – 1269
DRG ELISA (EIA-5298) pg/mL 89.8 49.4 – 130 277 152 – 401 744 409 – 1079
IBL ELISA pg/mL
MP BioMedicals ImmuChem DA RIA pg/mL 66.0 55.0 – 77.0 114 96.0 – 132 404 304 – 504
ZenTech MAiAZEN pg/mL 197 150 – 244 282 188 – 375 717 402 – 1032
ZenTech RiAZEN pg/mL 107 77.4 – 136 204 148 – 259 603 349 – 857
AMIKACIN
Emit µg/mL 4.52 2.87 – 6.17 14.0 9.66 – 18.3 24.6 17.3 – 32.0
AMITRIPTYLINE
HPLC ng/mL § § §
ANDROSTENEDIONE (2)
Beckman Coulter RIA (DSL3800) ng/mL 0.610 0.380 – 0.840 1.58 1.13 – 2.03 2.84 2.17 – 3.51
Beckman Coulter RIA Delta4 (IM0674) ng/mL 1.33 0.900 – 1.77 2.85 2.00 – 3.71 4.10 2.50 – 5.70
Calbiotech ELISA ng/mL 1.36 0.900 – 1.81 3.43 2.26 – 4.59 6.68 4.40 – 8.96
Diagnostics Biochem Canada ELISA ng/mL 0.800 0.600 – 1.00 2.21 1.68 – 2.74 3.78 2.57 – 4.99

Page 3 English • 2017-01 • 1536-00

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ANDROSTENEDIONE (2) (continued)
DiaMetra ELISA ng/mL 0.220 0.110 – 0.340 1.45 0.970 – 1.92 2.34 1.50 – 3.19
DIAsource RIA CT ng/mL 0.695 0.563 – 0.827 2.25 1.73 – 2.76 3.81 3.35 – 4.26
DRG ELISA (EIA-3265) ng/mL 0.790 0.430 – 1.15 2.09 1.15 – 3.02 4.31 2.37 – 6.25
IBL ELISA ng/mL
MP BioMedicals ImmuChem DA RIA ng/mL 1.56 1.26 – 1.86 3.60 2.70 – 4.50 4.20 3.60 – 4.80
ZenTech RiAZEN ng/mL 0.480 0.330 – 0.630 1.55 1.29 – 1.80 2.74 2.20 – 3.27
ANGIOTENSIN I (2)
Cisbio Bioassays REN-CT2 pg/mL 33.0 26.0 – 40.0 40.0 32.0 – 48.0 40.0 32.0 – 48.0
ZenTech Renin MAIA ng/mL/hr 3.38 2.12 – 4.64 6.84 3.80 – 9.88 7.35 3.92 – 10.8
CAFFEINE
Emit µg/mL 2.00 1.32 – 2.68 7.13 5.16 – 9.10 14.6 10.5 – 18.6
CALCITONIN (2)
Biomerica ELISA pg/mL 67.5 61.0 – 73.9 336 288 – 384 568 512 – 623
Cisbio Bioassays pg/mL 66.0 53.0 – 79.0 253 206 – 300 400 320 – 480
DIAsource CT US IRMA 2nd IS 89/620 pg/mL 62.2 49.9 – 74.5 265 219 – 311 388 324 – 451
EUROIMMUN IRMA CT pg/mL 45.0 33.0 – 56.0 266 200 – 332 444 333 – 555
IBL RIA pg/mL 59.8 47.9 – 71.8 263 210 – 315 474 379 – 568
Institute of Isotopes IRMA pg/mL 31.2 23.4 – 39.0 215 172 – 258 386 309 – 463
CARBAMAZEPINE
CEDIA II (2) µg/mL 3.19 2.23 – 4.15 8.16 6.84 – 9.48 13.1 11.0 – 15.2
Emit 2000 µg/mL 2.77 <2.00 – 3.68 7.60 5.92 – 9.28 12.9 10.4 – 15.4
Sekisui Medical Nanopia (2) µg/mL 2.19 1.31 – 3.07 8.18 5.73 – 10.6 14.5 11.6 – 17.4
CEA (2)
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 1.48 0.990 – 1.98 12.3 8.22 – 16.5 20.6 13.5 – 27.7
Cisbio Bioassays ng/mL 1.75 1.40 – 2.10 11.2 9.00 – 13.4 25.8 20.6 – 31.0
DiaMetra ELISA ng/mL <5.00 11.8 7.85 – 15.8 17.8 11.6 – 24.1
DIAsource IRMA ng/mL 3.08 2.22 – 3.93 27.3 20.1 – 34.4 61.6 43.1 – 80.0
HUMAN ELISA ng/mL 1.75 1.17 – 2.32 12.1 8.09 – 16.1 17.7 11.8 – 23.5
IBL ELISA ng/mL
Institute of Isotopes IRMA ng/mL 2.03 1.62 – 2.44 12.1 9.70 – 14.5 26.1 20.9 – 31.4
Monobind AccuBind (NG ELISA) ng/mL 1.34 0.900 – 1.78 12.3 8.22 – 16.3 19.0 12.7 – 25.2
Monobind AccuBind ELISA ng/mL 1.75 1.17 – 2.32 12.1 8.09 – 16.1 17.7 11.8 – 23.5
Monobind AccuLite (NG CLIA) ng/mL 0.900 0.600 – 1.19 9.61 6.44 – 12.8 15.2 10.2 – 20.2
Monobind AccuLite CLIA ng/mL 1.62 1.08 – 2.15 11.4 7.63 – 15.2 17.4 11.7 – 23.1
CHLORAMPHENICOL
HPLC µg/mL § § §
CORTISOL (2)
Beckman Coulter RIA (IM1841) µg/dL 3.18 2.02 – 4.35 14.4 11.5 – 17.3 22.0 16.6 – 27.5
Calbiotech ELISA ng/mL 34.7 23.1 – 46.4 228 152 – 304 595 395 – 795
Cisbio Bioassays µg/dL 2.43 1.96 – 2.90 14.9 12.0 – 17.8 23.6 18.8 – 28.3
DIALAB Cortisol ng/mL 34.0 24.8 – 43.2 342 271 – 413 506 451 – 561
DiaMetra ELISA ng/mL 17.3 11.5 – 23.1 219 149 – 289 356 236 – 475
DIAsource RIA CT µg/dL 5.75 4.03 – 7.48 24.7 17.3 – 32.1 34.7 30.1 – 39.3
DRG ELISA (EIA-1887) ng/mL 36.5 23.4 – 49.6 203 130 – 275 309 197 – 420
HUMAN ELISA ng/mL 36.5 23.4 – 49.6 203 130 – 275 309 197 – 420
IBL LIA µg/dL
IBL Serum ELISA ng/mL 35.8 23.3 – 48.3 187 122 – 253 302 196 – 407
Institute of Isotopes IRMA ng/mL 36.1 28.9 – 43.4 159 127 – 191 236 189 – 283
Monobind AccuBind ELISA µg/dL 4.33 2.90 – 5.76 20.6 13.8 – 27.3 30.0 20.1 – 39.9
Monobind AccuLite CLIA µg/dL 4.20 2.81 – 5.58 18.5 12.4 – 24.7 27.0 18.1 – 35.9
MP BioMedicals Corti-Cote RIA µg/dL 3.00 2.60 – 3.40 17.7 15.1 – 20.3 27.2 23.2 – 31.2
MP BioMedicals ImmuChem CT RIA µg/dL 6.00 4.50 – 7.50 28.1 22.0 – 34.2 40.7 30.3 – 51.1
C-PEPTIDE (2)
Beckman Coulter IRMA (IM3639) ng/mL 1.51 1.02 – 2.00 5.61 3.57 – 7.64 6.43 4.62 – 8.24

Page 4 English • 2017-01 • 1536-00

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
C-PEPTIDE (2) (continued)
Calbiotech ELISA ng/mL 1.36 0.920 – 1.81 6.19 4.13 – 8.24 6.74 4.49 – 9.00
Cisbio Bioassays ng/mL 1.35 1.08 – 1.62 5.71 4.56 – 6.85 6.34 5.08 – 7.60
DIAsource C-PEP II RIA CT ng/mL 1.11 0.565 – 1.65 5.02 3.75 – 6.28 5.77 4.56 – 6.97
DRG ELISA (EIA-1293) ng/mL 0.960 0.530 – 1.39 4.95 2.72 – 7.18 5.90 3.24 – 8.55
IBL ELISA ng/mL
Institute of Isotopes IRMA ng/mL 1.70 1.27 – 2.12 7.18 5.74 – 8.61 8.14 6.51 – 9.77
Mercodia ELISA ng/mL § § §
Monobind AccuBind ELISA ng/mL 1.21 0.810 – 1.61 4.47 2.99 – 5.94 5.25 3.51 – 6.98
Monobind AccuLite CLIA ng/mL 1.09 0.730 – 1.45 4.50 3.02 – 5.99 5.41 3.62 – 7.19
DEHYDROEPIANDROSTERONE-SULFATE (DHEA-SULFATE) (2)
Beckman Coulter RIA (IM0729) µg/dL 70.1 59.1 – 81.1 129 104 – 154 629 418 – 840
Beckman Coulter RIA DHEA-S-7 (DSL2700) ng/mL 659 436 – 881 1514 1131 – 1897 4775 2873 – 6678
Calbiotech ELISA µg/mL 0.950 0.630 – 1.28 2.05 1.38 – 2.71 6.63 4.44 – 8.81
DiaMetra ELISA µg/mL 0.840 0.430 – 1.26 1.81 1.11 – 2.51 5.87 3.86 – 7.87
DIAsource RIA CT µg/dL 89.4 64.7 – 114 189 138 – 241 573 482 – 663
DRG ELISA (EIA-1562) µg/mL 0.420 0.230 – 0.610 1.19 0.660 – 1.73 4.08 2.24 – 5.92
HUMAN ELISA µg/mL 0.420 0.230 – 0.610 1.19 0.660 – 1.73 4.08 2.24 – 5.92
IBL ELISA µg/mL 0.800 0.520 – 1.08 1.90 1.23 – 2.56 7.15 4.64 – 9.65
Institute of Isotopes IRMA µg/mL 0.741 0.593 – 0.889 1.44 1.19 – 1.74 5.11 4.11 – 6.15
Monobind AccuBind ELISA µg/mL 0.710 0.480 – 0.940 1.87 1.25 – 2.48 5.85 3.92 – 7.78
Monobind AccuLite CLIA µg/mL 0.900 0.600 – 1.19 2.09 1.40 – 2.78 6.41 4.30 – >8.00
MP BioMedicals ImmuChem CT RIA ng/mL 413 337 – 489 1077 801 – 1353 3245 2372 – 4118
DESIPRAMINE
HPLC ng/mL § § §
DIGOXIN
Emit 2000 ng/mL 0.625 <0.200 – 1.13 1.62 0.955 – 2.28 3.05 2.20 – 3.90
Monobind AccuBind ELISA (2) ng/mL 0.710 0.480 – 0.950 1.95 1.31 – 2.59 3.07 2.06 – >4.00
Monobind AccuLite CLIA (2) ng/mL 0.720 0.480 – 0.950 2.06 1.38 – 2.74 3.49 2.34 – >4.00
Sekisui Medical Nanopia (2) ng/mL 0.450 0.270 – 0.630 1.75 1.23 – 2.28 3.04 2.43 – 3.65
DISOPYRAMIDE
Emit µg/mL § § §
ESTRADIOL (2)
Beckman Coulter RIA (A21854) pg/mL 59.3 36.1 – 82.5 101 65.7 – 135 192 141 – 242
Beckman Coulter RIA US Estradiol (DSL4800) pg/mL 46.0 27.2 – 64.8 89.1 66.9 – 111 169 106 – 232
BioCheck EIA pg/mL § § §
Calbiotech ELISA pg/mL 120 78.1 – 163 253 169 – 337 533 349 – 716
Cisbio Bioassays pg/mL 300 240 – 360 810 650 – 970
Cisbio Bioassays ESTR-US-CT pg/mL 45.0 33.2 – 56.7 95.4 76.3 – 114 183 147 – 218
DIALAB 17-beta pg/mL 113 81.4 – 145 374 304 – 445 895 802 – 987
DiaMetra ELISA (17 Beta) pg/mL 128 80.5 – 175 353 238 – 468 738 495 – 980
DIAsource E2 RIA CT pg/mL 77.0 54.0 – 100 183 128 – 238 419 351 – 487
DRG ELISA (EIA-2963) pg/mL 141 78.9 – 203 399 224 – 575 744 417 – 1071
HUMAN ELISA pg/mL 230 129 – 332 602 337 – 866 1093 612 – 1574
IBL ELISA pg/mL
Monobind AccuBind ELISA pg/mL 95.7 64.1 – 127 203 136 – 270 339 225 – 446
Monobind AccuLite CLIA pg/mL 102 68.2 – 135 213 143 – 283 365 244 – 485
MP BioMedicals ImmuChem CT RIA pg/mL 67.0 50.0 – 84.0 224 174 – 274 579 443 – 715
MP BioMedicals ImmuChem DA RIA pg/mL 67.0 50.0 – 84.0 245 193 – 297 532 446 – 618
Pantex 100 uL Direct 125I pg/mL 76.0 62.0 – 91.0 178 154 – 202 334 291 – 377
ESTRIOL (FREE) (2)
Beckman Coulter RIA (IM3594) ng/mL 0.860 0.530 – 1.20 2.06 1.42 – 2.69 6.39 3.71 – 9.08
Calbiotech ELISA ng/mL 4.86 3.26 – 6.47 12.2 8.10 – 16.2 20.6 13.9 – 27.4
DiaMetra ELISA ng/mL 1.71 0.970 – 2.44 4.56 2.81 – 6.30 10.2 6.50 – >12.0
DRG ELISA (EIA-1612) ng/mL 2.41 1.33 – 3.50 5.89 3.24 – 8.54 13.7 7.54 – 19.9
HUMAN ELISA ng/mL 2.41 1.33 – 3.50 5.89 3.24 – 8.54 13.7 7.54 – 19.9

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ESTRIOL (FREE) (2) (continued)
IBL ELISA Unconjugated ng/mL
Monobind AccuBind ELISA ng/mL 2.84 1.90 – 3.78 5.70 3.82 – 7.58 12.0 8.06 – 16.0
Monobind AccuLite CLIA ng/mL 3.22 2.16 – 4.28 7.12 4.77 – 9.47 13.4 8.97 – 17.8
ESTROGEN (TOTAL) (2)
Calbiotech ELISA pg/mL § § §
MP BioMedicals ImmuChem DA RIA pg/mL 289 220 – 358 715 607 – 823 1359 1069 – 1649
ETHOSUXIMIDE
Emit µg/mL 31.7 20.3 – 43.0 66.5 39.0 – 93.9 98.1 62.0 – 134
FERRITIN (2)
Beckman Coulter IRMA (IM3492) ng/mL 70.3 44.6 – 96.1 149 101 – 198 349 273 – 425
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 55.6 36.7 – 74.5 131 85.1 – 176 370 246 – 495
DiaMetra ELISA ng/mL 56.6 37.7 – 75.5 140 93.5 – 186 368 242 – 495
Monobind AccuBind ELISA ng/mL 49.9 33.4 – 66.4 116 77.6 – 154 345 231 – 458
Monobind AccuLite CLIA ng/mL 49.3 33.1 – 65.6 123 82.7 – 164 382 256 – 508
FOLATE (2)
MP BioMedicals SimulTRAC SNB RIA ng/mL 2.20 1.70 – 2.70 7.90 6.60 – 9.20 13.4 11.2 – 15.6
MP BioMedicals SimulTRAC SP RIA ng/mL 3.70 3.10 – 4.30 8.80 7.20 – 10.4 13.2 9.90 – 16.5
FOLLICLE STIMULATING HORMONE (FSH) (2)
Beckman Coulter IRMA (IM2125) mIU/mL 3.74 2.46 – 5.02 13.4 10.6 – 16.2 23.8 19.3 – 28.3
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 5.06 3.73 – 6.38 17.2 11.6 – 22.8 26.1 17.2 – 35.0
DIALAB FSH mIU/mL 7.48 6.74 – 8.23 26.1 23.5 – 28.6 41.5 37.4 – 45.7
DiaMetra ELISA mIU/mL 5.62 <5.00 – 7.33 22.6 15.7 – 29.4 44.5 30.9 – 58.2
DIAsource IRMA mIU/mL 6.49 4.83 – 8.16 22.3 16.7 – 27.9 39.0 31.1 – 46.8
DRG ELISA (EIA-1288) mIU/mL 7.29 4.01 – 10.6 28.9 15.9 – 41.9 56.3 31.0 – 81.7
Fortress Diagnostics mIU/mL 4.69 3.75 – 5.63 16.7 13.3 – 20.0 32.2 25.8 – 38.6
HUMAN ELISA mIU/mL 4.25 2.85 – 5.65 18.7 12.5 – 24.9 38.6 25.9 – 51.4
IBL ELISA mIU/mL
Institute of Isotopes IRMA mIU/mL 7.07 5.66 – 8.49 25.8 20.7 – 31.0 47.7 38.2 – 57.3
Monobind AccuBind ELISA mIU/mL 4.25 2.85 – 5.65 18.7 12.5 – 24.9 38.6 25.9 – 51.4
Monobind AccuLite CLIA mIU/mL 4.52 3.03 – 6.01 19.0 12.7 – 25.2 40.6 27.2 – 54.0
MP BioMedicals ImmuChem CT IRMA mIU/mL 6.80 5.00 – 8.60 24.4 20.4 – 28.4 43.8 34.0 – 53.6
GASTRIN (2)
Cisbio Bioassays GASK-PR µIU/mL 56.0 45.0 – 67.0 231 185 – 277 490 390 – 590
IBL RIA µIU/mL
MP BioMedicals RIA pg/mL 81.0 61.0 – 101 312 262 – 362 599 446 – 752
GENTAMICIN
CEDIA II (2) µg/mL 2.15 1.43 – 2.87 4.46 3.32 – 5.60 6.47 5.06 – 7.88
Emit 2000 µg/mL 2.30 1.74 – 2.86 4.60 3.41 – 5.79 6.47 4.73 – 8.21
HCG (2)
Beckman Coulter IRMA (IM2110) mIU/mL <8.20 20.4 12.9 – 27.9 175 128 – 222
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 4.64 3.08 – 6.20 17.9 11.8 – 23.9 190 126 – 253
Cisbio Bioassays mIU/mL 8.50 6.80 – 10.2 21.9 17.5 – 26.3 189 151 – 227
DIAsource hCG + Beta IRMA mIU/mL 8.49 5.94 – 11.0 36.6 30.7 – 42.4 226 199 – 254
DRG ELISA (EIA-1469) mIU/mL 21.4 13.3 – 29.6 127 78.9 – 176
HUMAN ELISA mIU/mL 6.92 4.63 – 9.20 19.0 12.7 – 25.3 176 118 – 235
Institute of Isotopes IRMA (ßhCG) mIU/mL 6.06 4.85 – 7.28 20.9 16.7 – 25.0 207 165 – 248
Monobind AccuBind ELISA mIU/mL 6.92 4.63 – 9.20 19.0 12.7 – 25.3 176 118 – 235
Monobind AccuLite CLIA mIU/mL 6.88 4.61 – 9.15 19.4 13.0 – 25.8 165 117 – 220
HCG-BETA SUBUNIT (2)
Cisbio Bioassays ng/mL 0.060 0.040 – 0.080 0.120 0.090 – 0.150 1.37 1.09 – 1.65
DiaMetra ELISA mIU/mL 1.08 <1.00 – 1.60 7.09 4.30 – 9.87 143 97.1 – 189
DRG ELISA (EIA-1911) mIU/mL 3.24 2.01 – 4.47 11.1 6.89 – 15.3 74.9 46.4 – 103

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
HCG-BETA SUBUNIT (2) (continued)
IBL ELISA mIU/mL
HUMAN GROWTH HORMONE (HGH) (2)
Beckman Coulter IRMA (IM1397) µIU/mL 7.96 5.56 – 10.4 25.7 19.4 – 32.0 43.7 34.5 – 53.0
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 2.56 1.71 – 3.41 9.54 6.22 – 12.9 18.8 12.6 – 25.0
Cisbio Bioassays µIU/mL 8.90 7.10 – 10.7 28.8 22.6 – 35.0 46.0 37.0 – 55.0
DiaMetra ELISA µIU/mL 13.3 8.59 – 18.0 49.2 31.9 – 66.5 101 68.5 – 133
DIAsource IRMA µIU/mL 6.38 5.57 – 7.19 21.7 18.7 – 24.8 37.3 30.2 – 44.5
Institute of Isotopes IRMA µIU/mL 10.9 8.69 – 13.0 33.6 26.9 – 40.3 60.2 48.1 – 72.2
MEDIAGNOST ELISA µIU/mL 7.50 5.90 – 9.10 24.3 19.1 – 29.5 42.4 33.2 – 51.6
Monobind AccuBind ELISA µIU/mL 8.63 5.78 – 11.5 26.7 17.9 – 35.5 45.0 30.2 – 59.9
Monobind AccuLite CLIA µIU/mL 8.29 5.55 – 11.0 26.0 17.4 – 34.6 46.1 30.9 – 61.3
MP BioMedicals ImmuChem DA RIA ng/mL 6.70 5.50 – 7.90 17.4 15.1 – 19.7 28.8 23.6 – 34.0
ZenTech RiAZEN ng/mL 5.20 4.50 – 6.00 16.1 14.0 – 18.1 30.1 18.9 – 41.2
IGF-1/SOMATOMEDIN C (2)
Beckman Coulter IGF-1 RIA ng/mL 92.7 70.4 – 115 125 93.9 – 157 136 97.5 – 174
MEDIAGNOST IGF-1 ELISA (IGFBP Blocked) ng/mL 115 84.0 – 146 143 116 – 170 149 120 – 178
MEDIAGNOST IGF-1 RIA (IGFBP Blocked) ng/mL 115 84.0 – 146 143 116 – 170 149 120 – 178
IMIPRAMINE
HPLC ng/mL § § §
IMMUNOGLOBULIN E (IGE)
BioCheck EIA IU/mL § § §
Calbiotech ELISA (2) IU/mL >400 113 75.9 – 150 152 99.7 – 203
DiaMetra ELISA (2) IU/mL 374 247 – >400 102 57.9 – 146 157 94.8 – 219
EUROIMMUN Total IgE ELISA (2) IU/mL 316 221 – 411 111 77.9 – 145 125 87.3 – 162
ImmunoCAP total IgE IU/mL
Monobind AccuBind ELISA (2) IU/mL 304 203 – >400 88.0 58.9 – 117 114 76.6 – 152
Monobind AccuLite CLIA (2) IU/mL 285 191 – 379 71.3 47.8 – 94.9 95.7 64.1 – 127
Omega Diagnostics IgE ELISA (2) IU/mL 276 198 – 354 86.0 65.0 – 107 104 62.0 – 146
ZenTech RiAZEN (2) IU/mL 441 328 – 554 116 74.8 – 157 148 76.0 – 219
INSULIN (2)
Beckman Coulter IRMA (IM3210) µIU/mL 14.6 11.1 – 18.1 53.9 43.4 – 64.4 154 124 – 185
Calbiotech ELISA µIU/mL 11.8 7.81 – 15.8 85.1 56.2 – >100 >100
Cias INSULIN II and BIO Majesty 1650 µIU/mL 16.3 13.0 – 19.6 61.7 52.4 – 71.0 >100
Cisbio Bioassays BI-Insulin IRMA µIU/mL 17.8 14.2 – 21.4 60.0 48.0 – 72.0 201 161 – 241
DiaMetra ELISA µIU/mL 19.7 13.7 – 25.6 60.4 41.8 – 79.0 238 153 – >300
DIAsource IRMA µIU/mL 18.8 15.0 – 22.6 59.6 54.0 – 65.1 150 131 – 170
DRG ELISA (EIA-2935) µIU/mL 18.7 10.3 – 27.1 69.1 38.0 – >100 >100
Institute of Isotopes IRMA µIU/mL 18.4 14.8 – 22.1 62.6 50.1 – 75.2 161 129 – 193
Mercodia ELISA µIU/mL § § §
Mercodia ELISA (Iso-Insulin) µIU/mL § § §
Monobind AccuBind ELISA µIU/mL 10.0 6.72 – 13.3 44.0 29.5 – 58.6 125 84.0 – 167
Monobind AccuLite CLIA µIU/mL 9.43 6.32 – 12.5 39.3 26.4 – 52.3 126 84.7 – 168
MP BioMedicals ImmuChem CT RIA µIU/mL 18.6 13.8 – 23.4 87.0 66.0 – 108 233 200 – 266
Sekisui Medical Norudia µIU/mL 10.8 8.64 – 13.0 44.9 35.9 – 53.9 131 105 – >150
LIDOCAINE
Emit µg/mL § § §
LUTEINIZING HORMONE (LH) (2)
Beckman Coulter IRMA (IM1381) mIU/mL 1.24 0.960 – 1.52 17.8 15.6 – 19.9 61.4 52.1 – 70.7
BioCheck EIA mIU/mL § § §
Calbiotech ELISA mIU/mL 0.880 0.560 – 1.21 13.7 9.05 – 18.3 45.9 30.7 – >50.0
DIALAB LH mIU/mL 0.960 0.803 – 1.20 16.2 14.6 – 17.8 37.6 34.0 – 41.5
DiaMetra ELISA mIU/mL 1.10 0.590 – 1.60 16.8 11.2 – 22.3 59.6 39.0 – 80.2
DIAsource sp IRMA mIU/mL 0.760 0.530 – 0.980 10.6 8.90 – 12.3 38.6 36.8 – 40.4
DRG Serum ELISA (EIA-1289) mIU/mL 14.3 7.86 – 20.7 31.2 17.2 – 45.2

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
LUTEINIZING HORMONE (LH) (2) (continued)
HUMAN ELISA mIU/mL 1.46 0.980 – 1.94 20.5 13.8 – 27.3 65.4 43.8 – 87.0
IBL ELISA mIU/mL
Institute of Isotopes IRMA mIU/mL 1.30 1.04 – 1.56 16.1 12.9 – 19.3 55.7 44.5 – 66.8
Monobind AccuBind ELISA mIU/mL 1.46 0.980 – 1.94 20.5 13.8 – 27.3 65.4 43.8 – 87.0
Monobind AccuLite CLIA mIU/mL 0.880 0.590 – 1.17 19.6 13.1 – 26.1 71.2 47.7 – 94.6
MP BioMedicals ImmuChem CT IRMA mIU/mL <2.50 12.8 10.8 – 14.8 44.5 41.5 – 47.5
N-ACETYL PROCAINAMIDE (NAPA)
CEDIA µg/mL § § §
Emit 2000 µg/mL § § §
NORTRIPTYLINE
HPLC ng/mL § § §
PHENOBARBITAL
CEDIA II (2) µg/mL 8.93 7.76 – 10.1 23.5 21.6 – 25.3 47.5 44.1 – 50.9
Emit 2000 µg/mL 9.48 6.90 – 12.1 24.4 16.8 – 31.9 47.9 32.6 – 63.3
Sekisui Medical Nanopia (2) µg/mL 9.80 5.88 – 13.7 26.3 18.4 – 34.2 54.1 43.3 – 64.9
PHENYTOIN
CEDIA II (2) µg/mL 6.71 5.18 – 8.24 13.9 12.0 – 15.9 25.9 23.3 – 28.5
Emit 2000 µg/mL 6.28 4.46 – 8.11 13.2 9.22 – 17.1 24.2 16.3 – 32.0
Sekisui Medical Nanopia (2) µg/mL 7.00 4.20 – 9.80 14.6 10.2 – 19.0 29.7 23.8 – 35.6
PRIMIDONE
Emit µg/mL 2.97 <2.50 – 3.52 5.44 4.47 – 6.41 10.4 8.26 – 12.5
PROCAINAMIDE
CEDIA (2) µg/mL 1.88 0.680 – 3.08 8.59 6.19 – 11.0 12.5 10.1 – 14.9
Emit 2000 µg/mL § § §
PROGESTERONE (2)
Beckman Coulter RIA (IM1188) ng/mL 0.550 0.320 – 0.790 10.5 7.67 – 13.3 28.7 22.9 – 34.6
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 1.01 0.640 – 1.39 9.54 6.69 – 12.4 27.5 18.8 – 36.1
Diagnostics Biochem Canada ELISA ng/mL 0.140 <0.100 – 0.640 8.58 6.12 – 11.0 25.1 17.3 – 32.9
DIALAB Progesterone ng/mL 0.601 0.419 – 0.782 17.7 13.6 – 21.8 >42.0
DiaMetra ELISA ng/mL 0.580 0.300 – 0.850 14.4 9.74 – 19.1 38.3 24.6 – >40.0
DIAsource RIA CT ng/mL 1.79 1.25 – 2.33 13.6 11.9 – 15.3 34.2 24.0 – 44.4
DRG ELISA (EIA-1561) ng/mL 0.940 0.520 – 1.36 11.4 6.27 – 16.5 33.2 18.3 – 48.1
HUMAN ELISA ng/mL 0.940 0.520 – 1.36 11.4 6.27 – 16.5 33.2 18.3 – 48.1
IBL ELISA ng/mL
Monobind AccuBind ELISA ng/mL 1.22 0.820 – 1.62 12.1 8.08 – 16.0 25.1 16.8 – 33.4
Monobind AccuLite CLIA ng/mL 1.59 1.06 – 2.11 13.4 9.00 – 17.9 28.2 18.9 – 37.6
MP BioMedicals ImmuChem CT RIA ng/mL 1.37 1.12 – 1.62 15.7 12.0 – 19.4 34.5 29.5 – 39.5
MP BioMedicals ImmuChem DA RIA ng/mL 0.670 0.500 – 0.840 8.50 7.30 – 9.70 21.5 17.5 – 25.5
PROLACTIN (2)
Beckman Coulter IRMA (IM2121) ng/mL 4.81 3.04 – 6.57 13.5 10.1 – 17.0 27.8 21.7 – 33.8
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 6.19 4.14 – 8.25 17.3 11.5 – 23.0 42.4 28.4 – 56.5
DIALAB Prolactin ng/mL 6.18 5.56 – 6.79 18.5 16.7 – 20.3 37.8 34.0 – 41.5
DiaMetra ELISA ng/mL 6.19 <5.00 – 8.26 19.0 13.2 – 24.9 34.3 22.5 – 46.0
DIAsource IRMA ng/mL 2.15 1.51 – 2.80 8.98 7.78 – 10.2 14.7 12.6 – 16.9
DRG ELISA (EIA-1291) ng/mL 5.39 2.96 – 7.82 12.6 6.93 – 18.3 27.0 14.8 – 39.1
Fortress Diagnostics ng/mL 6.80 5.44 – 8.16 27.3 21.8 – 32.8 54.1 43.3 – 64.9
HUMAN ELISA ng/mL 7.30 4.89 – 9.71 20.3 13.6 – 27.0 41.3 27.7 – 55.0
Institute of Isotopes IRMA ng/mL 5.01 4.01 – 6.02 13.4 10.7 – 16.1 27.4 21.9 – 32.8
Monobind AccuBind ELISA ng/mL 7.79 5.22 – 10.4 21.9 14.7 – 29.1 44.5 29.8 – 59.2
Monobind AccuLite CLIA ng/mL 7.58 5.08 – 10.1 22.5 15.1 – 29.9 46.8 31.3 – 62.2
MP BioMedicals ImmuChem CT IRMA ng/mL 9.60 8.30 – 10.9 27.9 24.1 – 31.7 55.4 48.0 – 62.8
PROPRANOLOL
HPLC ng/mL § § §

Page 8 English • 2017-01 • 1536-00

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
PSA (FREE) (2)
Beckman Coulter IRMA (IM2520) ng/mL 0.160 0.110 – 0.210 0.800 0.670 – 0.920 7.48 6.67 – 8.30
Cisbio Bioassays ng/mL 0.190 0.150 – 0.230 0.880 0.700 – 1.06 7.90 6.30 – 9.50
DiaMetra ELISA ng/mL <0.500 1.51 0.990 – 2.04 >10.0
HUMAN ELISA ng/mL 0.290 0.190 – 0.390 1.30 0.870 – 1.72 >10.0
Institute of Isotopes IRMA ng/mL 0.320 0.250 – 0.380 1.44 1.15 – 1.73 14.3 11.4 – 17.1
Monobind AccuBind ELISA ng/mL 0.290 0.200 – 0.390 1.30 0.870 – 1.72 >10.0
Monobind AccuLite CLIA ng/mL 0.240 0.160 – 0.320 1.31 0.880 – 1.74 >10.0
PSA (TOTAL) (2)
Beckman Coulter IRMA (IM1950) ng/mL 0.560 0.360 – 0.750 1.73 1.12 – 2.33 14.4 12.1 – 16.7
BioCheck EIA ng/mL § § §
Cisbio Bioassays ng/mL 0.830 0.660 – 1.00 2.65 2.10 – 3.20 18.1 14.5 – 21.7
DIALAB PSA ng/mL 0.902 0.534 – 1.27 1.96 1.10 – 2.82 19.3 13.8 – 24.8
DiaMetra ELISA ng/mL <5.00 <5.00 – 5.43 22.8 15.8 – 29.8
DRG ELISA (EIA-3719) ng/mL 0.760 0.420 – 1.10 2.17 1.41 – 2.93 16.9 11.0 – 22.8
Fortress Diagnostics ng/mL 0.770 0.620 – 0.920 3.16 2.53 – 3.79 25.9 19.8 – 31.1
HUMAN ELISA ng/mL 0.910 0.500 – 1.32 3.23 2.10 – 4.36 26.5 17.2 – 35.8
Institute of Isotopes IRMA ng/mL 0.700 0.560 – 0.840 2.17 1.73 – 2.60 18.2 14.6 – 21.9
Monobind AccuBind ELISA ng/mL 0.770 0.520 – 1.03 2.69 1.80 – 3.58 22.2 14.9 – 29.5
Monobind AccuLite CLIA ng/mL 0.540 0.360 – 0.710 2.34 1.56 – 3.11 21.8 14.6 – 29.0
SALICYLATE
Cambridge Life Sciences (K9001) (2) mg/dL 3.25 2.60 – 3.88 15.8 12.7 – 19.0 46.7 37.3 – 56.0
Emit mg/dL 4.03 3.13 – 4.92 17.0 15.1 – 19.0 45.2 39.8 – 50.7
SEKURE (Sekisui Diagnostics) (2) mg/dL <5.30 15.8 11.8 – 19.8 44.6 33.4 – 55.8
T3 (FREE) (2)
Beckman Coulter RIA (IM1579) pg/mL 2.52 1.76 – 3.28 8.77 5.71 – 11.8 16.2 11.8 – 20.5
BRAHMS Diagnostica RIA pg/mL § § §
BRAHMS Diagnostica RIA SPART pg/mL 3.18 2.27 – 4.09 12.3 9.42 – 15.3 26.0 21.0 – 31.0
Calbiotech ELISA pg/mL 1.52 0.950 – 2.09 6.23 4.19 – 8.28 10.4 6.80 – 14.0
Cisbio Bioassays pg/mL 2.63 2.06 – 3.20 7.00 5.60 – 8.40 12.6 10.1 – 15.1
Demeditec Diagnostics RIA/CT (DE 06100) pg/mL
DiaMetra ELISA pg/mL 2.20 1.47 – 2.92 4.20 2.75 – 5.65 6.58 4.37 – 8.78
DiaSorin CTK pg/mL
EUROIMMUN RIA CT pg/mL 2.68 2.01 – 3.35 8.77 6.56 – 11.0 25.1 18.8 – >26.0
Fortress Diagnostics pg/mL 1.95 1.56 – 2.34 4.40 3.52 – 5.28 7.22 5.78 – 8.66
HUMAN ELISA pg/mL 2.61 1.75 – 3.47 4.87 3.26 – 6.47 7.45 5.00 – 9.91
Monobind AccuBind ELISA pg/mL 2.61 1.75 – 3.47 4.87 3.26 – 6.47 7.45 4.99 – 9.91
Monobind AccuLite CLIA pg/mL 2.76 1.85 – 3.67 5.01 3.36 – 6.66 7.62 5.11 – 10.1
MP BioMedicals SPCS RIA pg/mL 1.07 0.820 – 1.32 3.77 2.94 – 4.60 6.47 5.50 – 7.44
T3 (TOTAL) (2)
Beckman Coulter RIA (IM1699) ng/dL 84.4 54.5 – 114 173 129 – 216 299 214 – 383
BioCheck EIA ng/mL § § §
BRAHMS Diagnostica RIA ng/dL 90.9 71.4 – 110 169 136 – 201 286 227 – 344
Calbiotech ELISA ng/dL 146 98.0 – 194 272 182 – 363 393 262 – 524
Cisbio Bioassays ng/mL 0.590 0.470 – 0.710 1.39 1.11 – 1.67 2.55 2.00 – 3.10
DIALAB T3 ng/mL 1.57 1.32 – 1.82 2.75 2.30 – 3.15 3.91 3.25 – 4.44
DiaMetra ELISA ng/mL 0.980 0.660 – 1.29 1.96 1.36 – 2.55 2.95 2.02 – 3.87
DiaSorin CTK ng/mL 0.909 0.714 – 1.10 1.69 1.36 – 2.01 2.86 2.27 – 3.44
DIAsource RIA CT ng/dL 54.0 46.6 – 61.4 121 107 – 135 221 190 – 253
DRG ELISA (EIA-4569) ng/dL 124 68.0 – 179 240 132 – 348 369 203 – 535
Fortress Diagnostics ng/mL 0.900 0.720 – 1.08 2.40 1.92 – 2.88 3.98 3.18 – 4.78
HUMAN ELISA ng/dL 101 68.0 – 134 201 135 – 268 331 221 – 440
Institute of Isotopes IRMA ng/dL
Monobind AccuBind ELISA ng/mL 1.01 0.680 – 1.34 2.01 1.35 – 2.68 3.31 2.21 – 4.40
Monobind AccuLite CLIA ng/mL 0.920 0.620 – 1.23 2.04 1.37 – 2.72 3.36 2.25 – 4.46
MP BioMedicals SPCS RIA ng/dL 72.0 60.0 – 84.0 179 151 – 207 306 258 – 354

Page 9 English • 2017-01 • 1536-00

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
T3 UPTAKE/T UPTAKE (2)
Beckman Coulter RIA (A30282) % Uptake 37.3 29.5 – 45.0 42.1 33.2 – 50.9 43.4 36.2 – 50.7
CEDIA % Uptake 34.8 30.9 – 38.7 41.9 37.0 – 46.9 44.4 39.3 – 49.5
DRI % Uptake 31.6 26.9 – 36.4 41.0 34.9 – 47.2 45.7 38.8 – >50.0
Monobind AccuBind ELISA % Uptake 29.6 27.4 – 31.8 35.5 32.7 – 38.3 43.9 36.9 – 51.0
Monobind AccuLite CLIA % Uptake 28.7 25.6 – 31.9 35.3 32.1 – 38.6 42.5 37.5 – 47.5
MP BioMedicals SPCS RIA % Uptake 35.7 32.3 – 39.1 42.4 39.1 – 45.7 45.0 39.3 – 50.7
T4 (FREE) (2)
Beckman Coulter RIA (IM1363) pg/mL 10.5 7.70 – 13.3 24.2 19.1 – 29.1 37.9 28.5 – 47.3
BRAHMS Diagnostica RIA pg/mL 10.9 8.53 – 13.2 31.0 27.1 – 34.9 49.6 43.4 – 55.8
Calbiotech ELISA ng/dL 0.790 0.520 – 1.07 2.07 1.36 – 2.77 3.41 2.25 – 4.56
Cisbio Bioassays pg/mL 7.60 6.10 – 9.10 28.9 22.8 – 35.0 41.0 33.0 – 49.0
Demeditec Diagnostics RIA/CT (DE 07100) ng/dL
DIALAB FT4 ng/dL 0.813 0.683 – 0.944 2.26 1.99 – 2.52 3.68 3.38 – 3.99
DiaMetra ELISA ng/dL 0.910 0.560 – 1.26 2.37 1.59 – 3.14 3.33 2.18 – 4.48
DiaSorin CTK pg/mL 10.9 8.53 – 13.2 31.0 27.1 – 34.9 49.6 43.4 – 55.8
EUROIMMUN RIA CT ng/dL 1.05 0.791 – 1.32 2.64 1.94 – 3.33 4.34 3.26 – 5.43
Fortress Diagnostics ng/dL 0.940 0.750 – 1.13 2.44 1.95 – 2.93 4.07 3.26 – 4.88
HUMAN ELISA ng/dL 0.940 0.630 – 1.25 2.27 1.52 – 3.02 3.81 2.55 – 5.07
Institute of Isotopes IRMA ng/dL
Monobind AccuBind ELISA ng/dL 0.940 0.630 – 1.25 2.27 1.52 – 3.02 3.81 2.55 – 5.07
Monobind AccuLite CLIA ng/dL 0.900 0.610 – 1.20 2.17 1.45 – 2.88 3.98 2.66 – 5.29
MP BioMedicals SPCS RIA ng/dL 0.570 0.450 – 0.690 1.90 1.48 – 2.32 3.04 2.54 – 3.54
T4 (TOTAL) (2)
Beckman Coulter RIA (IM1447) µg/dL 4.57 3.45 – 5.68 9.46 6.91 – 12.0 12.9 10.2 – 15.7
BioCheck EIA µg/dL § § §
BRAHMS Diagnostica RIA µg/dL 5.58 4.65 – 6.51 13.2 10.4 – 16.0 19.7 14.2 – 25.2
Calbiotech ELISA µg/dL 5.56 3.64 – 7.49 12.0 8.00 – 16.0 16.0 10.7 – 21.3
CEDIA µg/dL 5.48 4.31 – 6.65 12.4 10.5 – 14.2 16.9 13.9 – 20.0
Cisbio Bioassays ng/mL 50.0 40.0 – 60.0 104 83.0 – 125 158 126 – 190
DIALAB T4 µg/dL 3.11 2.49 – 3.74 8.60 6.82 – 10.3 13.1 11.0 – 15.3
DiaMetra ELISA µg/dL 6.06 3.98 – 8.14 11.1 7.08 – 15.0 14.4 9.40 – 19.4
DiaSorin CTK µg/dL 5.58 4.65 – 6.51 13.2 10.4 – 16.0 19.7 14.2 – 25.2
DIAsource RIA CT µg/dL 4.84 4.36 – 5.33 8.22 6.74 – 9.77 10.5 8.14 – 12.9
DRG ELISA (EIA-4568) µg/dL 5.53 3.04 – 8.02 12.5 6.89 – 18.2 17.6 9.68 – 25.5
DRI µg/dL 5.40 4.30 – 6.45 11.9 9.52 – 14.3 18.4 14.7 – >20.0
Fortress Diagnostics µg/dL 5.60 4.48 – 6.72 12.6 10.1 – 15.1 18.4 14.7 – 22.1
HUMAN ELISA µg/dL 5.58 3.74 – 7.42 12.2 8.14 – 16.2 16.9 11.3 – 22.4
Institute of Isotopes IRMA µg/dL
Monobind AccuBind ELISA µg/dL 5.58 3.74 – 7.42 12.2 8.14 – 16.2 16.9 11.3 – 22.4
Monobind AccuLite CLIA µg/dL 6.20 4.16 – 8.25 11.5 7.69 – 15.3 15.5 10.4 – 20.7
MP BioMedicals SPCS RIA µg/dL 5.90 4.60 – 7.20 11.2 8.50 – 13.9 15.7 12.5 – 18.9
TESTOSTERONE (2)
Beckman Coulter RIA Direct (IM1119) ng/mL 0.930 0.620 – 1.24 3.92 2.51 – 5.33 6.95 4.67 – 9.23
Beckman Coulter RIA Extraction (IM1087) ng/mL 1.78 0.940 – 2.61 5.17 2.44 – 7.91 8.97 6.13 – 11.8
BioCheck EIA ng/mL § § §
Calbiotech ELISA ng/mL 1.11 0.740 – 1.49 3.94 2.62 – 5.26 5.56 3.66 – 7.46
Cisbio Bioassays ng/mL 1.84 1.38 – 2.31 4.78 3.80 – 5.76 9.51 7.20 – 11.8
DIALAB Testosterone ng/mL 0.697 0.294 – 1.10 4.22 1.64 – 6.79 10.6 6.40 – 14.7
DiaMetra ELISA ng/mL 0.900 0.530 – 1.27 5.18 3.55 – 6.82 11.7 7.93 – 15.5
DIAsource RIA CT ng/mL 0.900 0.670 – 1.10 3.28 2.76 – 3.80 5.73 4.46 – 6.99
DRG ELISA (EIA-1559) ng/mL 1.87 1.08 – 2.66 5.54 3.22 – 7.87 9.98 5.79 – 14.2
HUMAN ELISA ng/mL 1.87 1.08 – 2.66 5.54 3.22 – 7.87 9.98 5.79 – 14.2
IBL ELISA ng/mL 1.61 1.04 – 2.17 4.43 2.88 – 5.98 8.29 5.39 – 11.2
IBL LIA ng/dL
Monobind AccuBind ELISA ng/mL 1.39 0.930 – 1.89 5.40 3.62 – 7.18 8.78 5.88 – 11.7

Page 10 English • 2017-01 • 1536-00

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

METHOD (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
TESTOSTERONE (2) (continued)
Monobind AccuLite CLIA ng/mL 1.53 1.03 – 2.04 5.47 3.67 – 7.28 9.82 6.58 – >12.0
MP BioMedicals ImmuChem DA RIA ng/mL 1.30 1.03 – 1.57 3.90 3.20 – 4.60 6.70 5.60 – 7.80
ZenTech RiAZEN ng/mL 1.10 0.600 – 1.70 3.20 2.10 – 4.20 5.40 2.50 – 8.30
TESTOSTERONE (FREE) (2)
Beckman Coulter RIA (DSL4900) pg/mL 4.15 2.31 – 5.98 14.4 10.3 – 18.5 26.0 18.2 – 33.8
Calbiotech ELISA pg/mL 2.30 1.53 – 3.06 9.22 6.11 – 12.3 16.9 11.3 – 22.5
DiaMetra ELISA pg/mL 2.90 1.91 – 3.88 14.4 9.62 – 19.2 28.5 18.7 – 38.2
DIAsource RIA CT pg/mL 2.95 2.32 – 3.57 14.2 11.5 – 16.8 24.0 19.2 – 29.9
IBL ELISA pg/mL 4.60 3.70 – 5.50 15.2 12.2 – 18.3 31.3 25.0 – 37.5
Monobind AccuBind ELISA pg/mL 2.92 1.96 – 3.88 10.4 6.98 – 13.9 22.3 14.9 – 29.7
Monobind AccuLite CLIA pg/mL 2.79 1.87 – 3.71 17.0 11.4 – 22.6 29.1 19.5 – 38.7
THEOPHYLLINE
CEDIA II (2) µg/mL 3.95 2.00 – 5.90 14.0 10.8 – 17.1 26.6 22.9 – 30.4
Emit 2000 µg/mL 4.13 2.96 – 5.30 13.8 10.0 – 17.5 25.8 18.2 – 33.4
Sekisui Medical Nanopia (2) µg/mL 3.64 2.18 – 5.10 15.6 10.9 – 20.3 31.0 24.8 – 37.2
THYROID STIMULATING HORMONE (TSH) (2)
Beckman Coulter IRMA (IM3712) µIU/mL 0.470 0.220 – 0.720 6.43 5.17 – 7.69 38.2 27.1 – 49.4
BioCheck EIA µIU/mL § § §
BRAHMS Diagnostica LIA µIU/mL 0.600 0.500 – 0.700 7.20 6.10 – 8.30 42.0 36.0 – 48.0
BRAHMS Diagnostica RIA µIU/mL 0.660 0.520 – 0.800 7.30 6.30 – 8.30 42.0 34.0 – 50.0
Calbiotech ELISA µIU/mL 0.320 0.210 – 0.430 3.08 2.03 – 4.13 22.3 14.7 – 29.9
Cisbio Bioassays µIU/mL 0.690 0.540 – 0.840 6.30 5.00 – 7.60 34.0 27.0 – 41.0
DIALAB TSH µIU/mL 0.425 0.285 – 0.565 4.67 3.98 – 5.39 >15.0
DiaMetra ELISA µIU/mL 0.470 0.280 – 0.650 5.36 3.56 – 7.17 >20.0
DiaSorin CTK3 µIU/mL 0.660 0.520 – 0.800 7.30 6.30 – 8.30 42.0 34.0 – 50.0
DIAsource IRMA µIU/mL 0.590 0.515 – 0.665 6.29 5.79 – 6.79 35.5 32.5 – 38.7
DRG ELISA (EIA-4171) µIU/mL 0.350 0.190 – 0.500 4.60 2.99 – 6.22 >15.0
EUROIMMUN IRMA CT µIU/mL 0.430 0.320 – 0.540 5.30 4.00 – 6.60 29.3 22.0 – 36.6
Fortress Diagnostics µIU/mL 0.310 0.250 – 0.370 5.94 4.74 – 7.14 33.1 26.5 – 39.7
HUMAN ELISA µIU/mL 0.330 0.180 – 0.480 4.69 3.05 – 6.34
IBL ELISA µIU/mL
Institute of Isotopes IRMA (Turbo-hTSH) µIU/mL 0.490 0.370 – 0.620 6.00 4.80 – 7.20 34.0 27.2 – 40.8
Monobind AccuBind ELISA µIU/mL 0.420 0.280 – 0.550 5.22 3.49 – 6.94 31.7 21.2 – >40.0
Monobind AccuLite CLIA µIU/mL 0.350 0.230 – 0.460 5.02 3.36 – 6.68 30.3 20.3 – >40.0
MP BioMedicals ImmuChem CT IRMA µIU/mL 0.560 0.430 – 0.690 6.20 5.30 – 7.10 34.5 29.8 – 39.2
THYROXINE BINDING GLOBULIN (TBG) (2)
BRAHMS Diagnostica RIA µg/mL 14.7 12.1 – 17.3 13.6 11.6 – 15.6 14.4 12.1 – 16.7
TOBRAMYCIN
CEDIA (2) µg/mL 0.850 <0.240 – 1.69 3.19 2.11 – 4.27 7.02 5.58 – 8.46
Emit 2000 µg/mL 1.05 <0.600 – 1.51 2.83 2.23 – 3.43 5.73 5.03 – 6.44
VALPROIC ACID
CEDIA II µg/mL 32.1 24.6 – 39.6 75.2 60.2 – 90.2 119 98.0 – 139
Emit 2000 µg/mL 36.4 28.4 – 44.3 76.1 62.1 – 90.0 117 95.0 – 139
Sekisui Medical Nanopia (2) µg/mL 34.5 20.7 – 48.3 82.3 57.6 – 107 127 102 – >150
VANCOMYCIN
Emit 2000 µg/mL 6.14 4.21 – 8.06 15.5 9.01 – 22.1 27.2 14.2 – 40.3
Sekisui Medical Nanopia (2) µg/mL 7.27 4.36 – 10.2 19.2 13.4 – 25.0 34.2 27.4 – 41.0
VITAMIN B12 (2)
Monobind AccuBind ELISA pg/mL 444 298 – 591 626 419 – 833 763 511 – 1015
Monobind AccuLite CLIA pg/mL 375 251 – 499 570 364 – 776 741 496 – 985
MP BioMedicals SimulTRAC SNB RIA pg/mL 313 242 – 384 537 454 – 620 637 511 – 763
MP BioMedicals SimulTRAC SP RIA pg/mL 385 322 – 448 577 494 – 660 706 599 – 813

Page 11 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ABBOTT ARCHITECT cSYSTEMS
Acetaminophen (MULTIGENT) µg/mL 9.50 6.92 – 12.1 34.1 29.1 – 39.2 107 94.6 – 120
Amikacin (MULTIGENT) µg/mL 4.10 2.88 – 5.32 13.9 11.7 – 16.1 26.1 22.0 – 30.3
Carbamazepine (5P05-21) µg/mL 2.60 1.93 – 3.27 7.60 6.22 – 8.98 12.9 11.0 – 14.9
Digoxin (MULTIGENT) ng/mL 0.664 0.403 – 0.926 1.67 1.32 – 2.01 3.12 2.49 – 3.75
Gentamicin (MULTIGENT) µg/mL 2.32 1.51 – 3.13 4.57 3.69 – 5.44 6.60 5.58 – 7.61
Immunoglobulin A (IgA) mg/dL 165 155 – 175 158 148 – 168 163 153 – 174
Immunoglobulin E (IgE) (MULTIGENT) IU/mL 317 257 – 377 84.4 49.4 – 119 113 71.9 – 155
Immunoglobulin G (IgG) mg/dL 765 719 – 810 796 759 – 832 787 749 – 825
Immunoglobulin M (IgM) mg/dL 55.0 47.7 – 62.2 64.8 58.2 – 71.4 60.9 53.6 – 68.3
Iron µg/dL 99.4 94.9 – 104 86.2 81.8 – 90.6 81.3 76.9 – 85.8
Lithium (MULTIGENT) mEq/L 0.492 0.369 – 0.615 1.26 1.06 – 1.46 1.87 1.65 – 2.09
Phenobarbital (5P07-21) µg/mL 9.38 6.95 – 11.8 23.9 19.6 – 28.2 47.3 39.6 – 55.0
Phenytoin (5P08-21) µg/mL 6.88 5.49 – 8.27 14.6 11.3 – 17.9 24.5 17.8 – 31.2
Salicylate (MULTIGENT) mg/dL <5.00 15.7 13.3 – 18.1 43.5 39.5 – 47.6
Theophylline (5P06-21) µg/mL 4.52 3.90 – 5.14 15.1 13.0 – 17.1 29.0 22.5 – 35.4
Tobramycin (MULTIGENT) µg/mL 0.751 0.518 – 0.984 2.77 2.25 – 3.29 4.83 3.98 – 5.68
Valproic Acid (MULTIGENT) µg/mL 30.1 20.3 – 39.9 69.2 58.2 – 80.2 114 102 – 126
Vancomycin (MULTIGENT) µg/mL 6.69 5.17 – 8.20 18.5 14.4 – 22.6 32.1 24.9 – 39.4
ABBOTT ARCHITECT iSYSTEMS
AFP ng/mL 15.3 11.4 – 19.2 95.1 68.7 – 121 193 130 – 256
Carbamazepine (1P36-25) µg/mL 2.88 2.38 – 3.38 7.60 6.48 – 8.72 12.3 10.6 – 14.0
Carbamazepine (1P36-27) µg/mL 2.88 2.38 – 3.38 7.60 6.48 – 8.72 12.3 10.6 – 14.0
CEA ng/mL 2.47 1.68 – 3.26 19.1 15.9 – 22.3 42.5 35.9 – 49.1
Cortisol µg/dL 3.17 2.40 – 3.93 15.5 12.3 – 18.7 23.6 19.1 – 28.0
C-Peptide ng/mL 1.12 0.356 – 1.89 4.68 3.01 – 6.36 5.17 3.23 – 7.11
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 79.3 67.5 – 91.0 171 147 – 194 609 525 – 694
Digoxin ng/mL 0.511 0.328 – 0.693 1.58 1.30 – 1.85 3.02 2.61 – 3.42
Estradiol pg/mL 80.3 62.7 – 97.9 196 170 – 221 360 324 – 396
Ferritin ng/mL 70.3 56.1 – 84.4 184 141 – 226 480 368 – 591
Folate ng/mL 4.19 2.17 – 6.21 11.7 7.97 – 15.4 15.3 – >20.0
Follicle Stimulating Hormone (FSH) mIU/mL 5.94 5.10 – 6.78 22.2 18.9 – 25.5 40.9 34.4 – 47.4
Gentamicin µg/mL 2.16 1.80 – 2.51 4.36 3.55 – 5.17 6.67 5.38 – 7.95
hCG mIU/mL 4.99 2.97 – 7.00 19.0 14.8 – 23.1 171 140 – 202
Insulin µIU/mL 14.3 12.3 – 16.2 51.9 45.6 – 58.1 153 133 – 172
Luteinizing Hormone (LH) mIU/mL 1.08 0.822 – 1.33 14.2 11.3 – 17.1 47.9 38.0 – 57.7
Phenobarbital µg/mL 10.3 8.43 – 12.2 24.9 20.8 – 29.0 48.5 40.7 – 56.4
Phenytoin µg/mL 6.55 5.57 – 7.53 13.3 11.1 – 15.4 24.7 21.2 – 28.1
Progesterone ng/mL 0.807 0.588 – 1.03 9.37 7.14 – 11.6 27.8 20.6 – 35.0
Prolactin ng/mL 7.29 6.03 – 8.54 20.5 17.1 – 24.0 42.7 35.4 – 50.1
PSA (Free) ng/mL 0.242 0.184 – 0.300 1.18 0.973 – 1.38 12.2 9.64 – 14.8
PSA (Total) ng/mL 0.603 0.478 – 0.727 1.95 1.58 – 2.31 16.4 13.3 – 19.6
T3 (Free) pg/mL 2.33 1.74 – 2.92 6.03 4.65 – 7.41 11.8 9.21 – 14.4
T3 (Total) ng/mL 0.825 0.623 – 1.03 1.87 1.53 – 2.20 2.97 2.47 – 3.47
T3 Uptake/T Uptake T Uptake Unit 1.08 0.657 – 1.50 0.989 0.669 – 1.31 1.01 0.655 – 1.36
T4 (Free) ng/dL 0.888 0.753 – 1.02 2.36 1.82 – 2.90 3.88 2.85 – 4.91
T4 (Total) µg/dL 4.98 3.97 – 5.99 11.7 9.24 – 14.1 18.3 14.5 – 22.1
Testosterone ng/dL 228 156 – 301 574 422 – 727 984 793 – 1175
Theophylline µg/mL 4.34 3.51 – 5.17 13.8 11.4 – 16.3 25.9 20.9 – 31.0
Thyroid Stimulating Hormone (TSH) µIU/mL 0.397 0.300 – 0.495 4.48 3.71 – 5.24 24.7 20.4 – 29.0
Valproic Acid µg/mL 31.5 25.4 – 37.6 73.1 60.3 – 85.9 113 93.8 – 133
Vancomycin (1P30-27) µg/mL 7.61 6.49 – 8.73 20.4 17.1 – 23.8 36.6 30.4 – 42.9
Vancomycin (1P30-28) µg/mL 7.61 6.49 – 8.73 20.4 17.1 – 23.8 36.6 30.4 – 42.9
Vitamin B12 pg/mL 403 232 – 575 606 386 – 825 771 509 – 1033
BECKMAN COULTER ACCESS / 2 / 2i
AFP ng/mL 17.0 12.1 – 21.8 94.7 71.6 – 118 209 159 – 259

Page 12 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
BECKMAN COULTER ACCESS / 2 / 2i (continued)
CEA (CEA2) ng/mL 2.32 1.79 – 2.85 19.2 14.9 – 23.5 42.1 33.1 – 51.1
Cortisol µg/dL 3.44 2.32 – 4.56 17.1 12.6 – 21.6 26.2 19.4 – 33.0
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL § § §
Digoxin ng/mL 0.632 0.347 – 0.917 1.80 1.31 – 2.28 3.28 2.61 – 3.95
Estradiol pg/mL 106 29.0 – 182 298 191 – 405 601 382 – 819
Estriol (Free) (Unconjugated Estriol) ng/mL 1.28 0.850 – 1.71 2.86 2.24 – 3.47 >6.90
Ferritin ng/mL 47.5 37.2 – 57.8 104 80.5 – 128 262 200 – 324
Folate (FOLW) ng/mL 3.95 2.72 – 5.19 10.3 7.55 – 13.1 16.3 12.1 – 20.6
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 7.25 5.72 – 8.79 22.3 16.8 – 27.8 35.1 26.6 – 43.7
hCG (Total ßhCG) (5th IS) mIU/mL 5.42 4.17 – 6.67 20.4 16.5 – 24.3 178 144 – 212
Human Growth Hormone (hGH) (Ultrasensitive hGH) ng/mL § § §
Immunoglobulin E (IgE) (Total IgE) IU/mL § § §
Insulin (Ultrasensitive Insulin) µIU/mL 14.7 12.2 – 17.2 55.4 45.7 – 65.0 162 133 – 190
Luteinizing Hormone (LH) (hLH) mIU/mL 1.03 0.667 – 1.40 15.9 12.2 – 19.6 52.7 39.5 – 65.8
Progesterone ng/mL 1.04 0.474 – 1.61 11.4 7.27 – 15.5 27.6 17.4 – 37.9
Progesterone (P4DE) ng/mL 0.650 0.270 – 1.06 9.09 5.54 – 12.7 24.0 14.5 – 34.1
Prolactin ng/mL 6.19 5.04 – 7.34 16.8 13.7 – 19.8 34.1 27.3 – 40.9
PSA (Free) (Hybritech free PSA) ng/mL 0.319 0.194 – 0.445 1.50 1.19 – 1.82 13.4 10.4 – 16.4
PSA (Free) (WHO 96/668) ng/mL 0.251 0.153 – 0.350 1.18 0.937 – 1.43 10.6 8.22 – 13.0
PSA (Total) (Hybritech PSA) ng/mL 0.738 0.545 – 0.930 2.43 1.98 – 2.88 20.6 16.3 – 24.9
PSA (Total) (WHO 96/670) ng/mL 0.624 0.461 – 0.786 1.89 1.67 – 2.24 16.0 12.7 – 19.4
T3 (Free) (Free T3) (2) pg/mL 2.39 1.91 – 2.87 5.30 4.24 – 6.36 9.23 7.39 – 11.1
T3 (Total) (Total T3) ng/mL 0.772 0.500 – 1.04 1.66 1.20 – 2.12 2.78 2.11 – 3.44
T3 Uptake/T Uptake % Uptake 45.1 37.1 – 53.1 49.3 40.7 – 57.9 54.1 44.7 – 63.5
T4 (Free) (Free T4) ng/dL 0.823 0.636 – 1.01 2.50 2.01 – 2.99 3.86 3.08 – 4.63
T4 (Total) (Total T4) µg/dL 5.16 3.35 – 6.96 11.2 8.23 – 14.1 15.6 12.1 – 19.1
Testosterone ng/mL 1.59 1.13 – 2.05 5.05 3.71 – 6.39 8.85 6.61 – 11.1
Thyroid Stimulating Hormone (TSH) (3rd IS) (2) µIU/mL 0.400 0.280 – 0.520 4.89 3.42 – 6.36 29.7 20.8 – 38.6
Thyroid Stimulating Hormone (TSH) (hTSH, Fast) µIU/mL 0.371 0.277 – 0.466 4.48 3.47 – 5.48 26.9 20.9 – 32.8
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.391 0.305 – 0.477 4.57 3.55 – 5.60 26.3 19.3 – 33.3
Vitamin B12 pg/mL 289 219 – 359 489 362 – 616 642 465 – 819
BECKMAN COULTER AU SYSTEMS
Acetaminophen µg/mL <10.0 – 12.5 35.0 28.3 – 41.7 107 88.2 – 126
Acetaminophen (Enzymatic Paracetamol, Europe) (2) µg/mL <15.0 36.4 29.2 – 43.7 106 85.2 – 128
Carbamazepine µg/mL 2.77 <2.00 – 3.68 7.60 5.92 – 9.28 12.9 10.4 – 15.4
Digoxin ng/mL 0.625 <0.200 – 1.13 1.62 0.955 – 2.28 3.05 2.20 – 3.90
Digoxin (Europe) ng/mL 0.767 0.245 – 1.29 1.93 1.25 – 2.61 3.59 2.76 – 4.43
Ferritin ng/mL 60.4 21.5 – 99.2 116 96.7 – 135 241 144 – 339
Gentamicin µg/mL 2.30 1.74 – 2.86 4.60 3.41 – 5.79 6.47 4.73 – 8.21
Immunoglobulin A (IgA) mg/dL 173 162 – 184 165 157 – 173 171 161 – 182
Immunoglobulin E (IgE) (Biomed) IU/mL 314 238 – 390 91.7 57.2 – 126 117 73.3 – 160
Immunoglobulin G (IgG) mg/dL 751 711 – 791 779 737 – 821 771 731 – 811
Immunoglobulin M (IgM) mg/dL 52.4 46.6 – 58.2 62.0 55.7 – 68.2 57.9 51.8 – 63.9
Lithium mEq/L 0.453 0.221 – 0.686 1.20 1.00 – 1.39 1.82 1.59 – 2.06
N-Acetyl Procainamide (NAPA) µg/mL § § §
Phenobarbital µg/mL 9.48 6.90 – 12.1 24.4 16.8 – 31.9 47.9 32.6 – 63.3
Phenytoin µg/mL 6.28 4.46 – 8.11 13.2 9.22 – 17.1 24.2 16.3 – 32.0
Procainamide µg/mL § § §
Salicylate mg/dL 4.03 3.13 – 4.92 17.0 15.1 – 19.0 45.2 39.8 – 50.7
T4 (Total) (DRI) µg/dL 5.96 4.39 – 7.53 11.9 9.92 – 13.9 13.4 11.3 – 15.5
Theophylline µg/mL 4.13 2.96 – 5.30 13.8 10.0 – 17.5 25.8 18.2 – 33.4
Tobramycin µg/mL 1.05 <0.600 – 1.51 2.83 2.23 – 3.43 5.73 5.03 – 6.44
Valproic Acid µg/mL 36.4 28.4 – 44.3 76.1 62.1 – 90.0 117 95.0 – 139
Vancomycin µg/mL 6.14 4.21 – 8.06 15.5 9.01 – 22.1 27.2 14.2 – 40.3

Page 13 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
BECKMAN COULTER SYNCHRON / UniCel DxC SERIES
Acetaminophen µg/mL 11.5 <10.0 – 17.5 38.2 29.0 – 47.4 118 101 – 136
Carbamazepine µg/mL 2.13 <2.00 – 2.77 7.07 5.80 – 8.34 12.0 9.90 – 14.1
Digoxin ng/mL 0.559 0.294 – 0.823 1.72 1.37 – 2.07 3.07 2.60 – 3.55
Gentamicin µg/mL 2.45 1.63 – 3.27 5.04 4.06 – 6.01 7.40 6.27 – 8.53
Immunoglobulin A (IgA) mg/dL 163 148 – 177 154 143 – 166 159 147 – 172
Immunoglobulin G (IgG) mg/dL § § §
Immunoglobulin M (IgM) mg/dL § § §
Iron µg/dL 98.0 94.5 – 102 86.1 82.7 – 89.4 81.6 78.2 – 85.0
Lithium (Infinity) mEq/L 0.437 0.265 – 0.608 1.18 0.959 – 1.40 1.82 1.55 – 2.09
Phenobarbital µg/mL 9.17 7.23 – 11.1 23.6 19.4 – 27.8 46.4 38.5 – 54.2
Phenytoin µg/mL 6.33 5.21 – 7.45 12.9 10.8 – 14.9 22.4 18.2 – 26.7
Salicylate mg/dL <4.00 – 6.35 16.4 13.8 – 19.0 45.7 38.4 – 52.9
Theophylline µg/mL 3.82 2.89 – 4.75 13.5 11.4 – 15.6 25.5 21.4 – 29.6
Tobramycin µg/mL 1.04 0.582 – 1.50 3.59 2.97 – 4.21 7.25 6.39 – 8.10
Valproic Acid µg/mL 16.9 <10.0 – 30.8 69.5 54.5 – 84.4 105 88.3 – 122
Vancomycin µg/mL 6.70 4.55 – 8.85 18.0 14.6 – 21.4 35.2 29.4 – >40.0
BECKMAN COULTER UniCel DxI
AFP ng/mL 16.0 11.3 – 20.8 90.5 67.9 – 113 193 144 – 241
CEA (CEA2) ng/mL 2.22 1.74 – 2.70 18.8 14.3 – 23.4 40.0 31.0 – 49.0
Cortisol µg/dL 2.97 1.75 – 4.19 17.0 13.2 – 20.8 25.6 18.7 – 32.4
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-S) µg/dL 62.7 45.0 – 80.3 134 101 – 166 441 345 – 537
Digoxin ng/mL 0.632 0.347 – 0.917 1.80 1.31 – 2.28 3.28 2.61 – 3.95
Estradiol pg/mL 106 29.0 – 182 298 191 – 405 601 382 – 819
Estriol (Free) (Unconjugated Estriol) ng/mL 1.28 0.850 – 1.71 2.86 2.24 – 3.47 >6.90
Ferritin ng/mL 47.8 37.3 – 58.3 104 78.0 – 131 267 203 – 331
Folate (FOLW) ng/mL 4.22 2.84 – 5.60 10.9 7.85 – 13.9 17.1 12.3 – 21.8
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 7.06 5.16 – 8.96 22.4 17.5 – 27.3 35.9 27.7 – 44.1
hCG (Total ßhCG) (5th IS) mIU/mL 5.42 4.17 – 6.67 20.4 16.5 – 24.3 178 144 – 212
Human Growth Hormone (hGH) (Ultrasensitive hGH) ng/mL § § §
Immunoglobulin E (IgE) (Total IgE) IU/mL 332 236 – 429 108 72.9 – 143 140 93.7 – 185
Insulin (Ultrasensitive Insulin) µIU/mL 14.9 11.0 – 18.8 53.5 43.9 – 63.1 157 128 – 187
Luteinizing Hormone (LH) (hLH) mIU/mL 1.03 0.667 – 1.40 15.9 12.2 – 19.6 52.7 39.5 – 65.8
Progesterone ng/mL 0.970 0.417 – 1.52 10.8 7.28 – 14.4 26.8 18.8 – 34.7
Progesterone (P4DE) ng/mL 0.600 0.240 – 0.990 8.56 5.55 – 11.8 23.3 15.8 – 30.9
Prolactin ng/mL 5.93 4.82 – 7.03 16.5 13.1 – 19.8 32.4 26.1 – 38.8
PSA (Free) (Hybritech free PSA) ng/mL 0.300 0.184 – 0.415 1.47 1.17 – 1.76 13.6 10.9 – 16.2
PSA (Free) (WHO 96/668) ng/mL 0.236 0.145 – 0.327 1.16 0.921 – 1.39 10.7 8.61 – 12.8
PSA (Total) (Hybritech PSA) ng/mL 0.774 0.580 – 0.968 2.45 2.00 – 2.89 21.3 17.2 – 25.3
PSA (Total) (WHO 96/670) ng/mL 0.654 0.490 – 0.818 1.91 1.69 – 2.25 16.6 13.4 – 19.7
T3 (Free) (Free T3) (2) pg/mL 2.39 1.88 – 2.80 5.01 3.95 – 5.95 8.27 6.61 – 9.93
T3 (Total) (Total T3) ng/mL 0.883 0.626 – 1.14 1.79 1.33 – 2.25 3.20 2.43 – 3.97
T3 Uptake/T Uptake % Uptake 46.5 37.8 – 55.1 50.1 41.5 – 58.8 54.2 45.3 – 63.1
T4 (Free) (Free T4) ng/dL 0.842 0.593 – 1.09 2.46 1.94 – 2.99 3.94 3.18 – 4.69
T4 (Total) (Total T4) µg/dL 5.15 3.65 – 6.64 10.8 8.36 – 13.2 15.6 11.9 – 19.3
Testosterone ng/mL 1.73 1.37 – 2.09 5.12 4.02 – 6.21 8.74 6.84 – 10.6
Thyroid Stimulating Hormone (TSH) (3rd IS) (2) µIU/mL 0.400 0.280 – 0.520 4.89 3.42 – 6.36 29.7 20.8 – 38.6
Thyroid Stimulating Hormone (TSH) (hTSH, Fast) µIU/mL § § §
Thyroid Stimulating Hormone (TSH) (hTSH, HYPERsensitive) µIU/mL 0.396 0.309 – 0.484 5.03 3.86 – 6.21 28.7 20.5 – 36.9
Vitamin B12 pg/mL 261 190 – 331 420 311 – 529 578 414 – 742
BIOMÉRIEUX VIDAS (2)
AFP ng/mL 16.6 12.0 – 21.2 94.0 69.9 – 118 218 176 – 260
CEA (S) ng/mL 1.70 <0.500 – 3.80 9.70 6.80 – 12.6 15.5 12.8 – 18.2
Cortisol (S) ng/mL 25.0 11.0 – 39.0 157 72.0 – 242 260 120 – 400
Digoxin ng/mL 0.560 0.350 – 0.770 1.70 1.30 – 2.10 3.30 2.60 – 4.00
Estradiol (II) pg/mL 114 82.0 – 146 324 253 – 395 736 589 – 883

Page 14 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
BIOMÉRIEUX VIDAS (2) (continued)
Ferritin ng/mL 58.0 36.0 – 80.0 110 82.0 – 138 265 202 – 328
Follicle Stimulating Hormone (FSH) mIU/mL 6.90 5.50 – 8.30 23.0 19.0 – 27.0 44.0 38.0 – 50.0
hCG mIU/mL 8.20 5.00 – 11.4 24.0 18.0 – 30.0 222 176 – 268
Immunoglobulin E (IgE) (Total) IU/mL 335 254 – 416 96.0 59.0 – 133 129 89.0 – 169
Luteinizing Hormone (LH) mIU/mL 1.20 0.700 – 1.70 13.3 11.3 – 15.3 51.0 43.0 – 59.0
Progesterone ng/mL 1.20 0.600 – 1.80 13.1 10.3 – 15.9 38.0 30.0 – 46.0
Prolactin ng/mL 5.50 3.40 – 7.60 18.4 14.1 – 22.7 36.0 30.0 – 42.0
PSA (Free) ng/mL 0.360 0.210 – 0.510 1.60 1.20 – 2.00 >10.0
PSA (Total) ng/mL 0.910 0.510 – 1.31 2.60 2.00 – 3.20 21.0 17.0 – 25.0
T3 (Free) pg/mL 2.34 1.62 – 3.05 6.43 4.94 – 7.92 11.5 8.83 – 14.2
T3 (Total) ng/mL 0.909 0.584 – 1.23 2.01 1.56 – 2.47 3.25 2.60 – 3.90
T4 (Free) (FT4N) (30459) ng/dL 0.977 0.620 – 1.33 3.18 2.02 – 4.34 5.27 3.33 – 7.21
T4 (Total) µg/dL 5.89 4.57 – 7.21 11.9 9.53 – 14.2 16.0 12.9 – 19.1
Testosterone (30418) ng/mL 1.67 1.15 – 2.19 11.2 8.90 – >13.0 >13.0
Testosterone (II) (414320) ng/mL 1.45 0.930 – 1.97 4.70 3.30 – 6.10 8.20 5.70 – 10.7
Thyroid Stimulating Hormone (TSH) µIU/mL 0.420 0.200 – 0.640 5.80 4.60 – 7.00 33.0 26.0 – 40.0
Thyroid Stimulating Hormone (TSH) (TSH3) µIU/mL 0.370 0.250 – 0.490 4.90 3.40 – 6.40 29.0 21.0 – 37.0
DIASORIN LIAISON (2)
ACTH pg/mL 49.8 36.6 – 63.0 127 82.0 – 172 295 201 – 389
AFP IU/mL 15.7 12.5 – 18.9 82.2 68.0 – 96.4 180 148 – 212
Aldosterone ng/dL 10.0 7.00 – 13.0 20.3 14.2 – 26.4 58.9 41.3 – 76.6
Calcitonin pg/mL 30.5 21.4 – 39.7 156 109 – 202 274 192 – 357
CEA ng/mL 2.40 1.85 – 2.95 15.9 13.5 – 18.3 37.5 30.8 – 44.2
Cortisol µg/dL 2.52 1.89 – 3.15 17.6 14.6 – 20.6 32.3 27.5 – 37.1
C-Peptide ng/mL 1.81 1.54 – 2.08 6.88 5.84 – 7.92 7.89 6.71 – 9.07
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 62.6 41.8 – 83.4 137 95.6 – 178 522 364 – 680
Estradiol (II Gen) (310680) pg/mL 67.3 45.1 – 89.4 188 132 – 245 340 238 – 442
Ferritin (Revised) ng/mL 60.9 51.7 – 70.1 130 110 – 150 328 279 – 377
Follicle Stimulating Hormone (FSH) mIU/mL 8.36 6.72 – 10.0 31.4 24.6 – 38.2 63.6 54.1 – 73.1
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 7.32 6.21 – 8.43 25.7 20.4 – 31.0 53.4 45.4 – 61.4
hCG (XL hCG) (REF 312321) mIU/mL 5.47 3.28 – 7.66 22.2 16.0 – 28.4 170 127 – 213
Human Growth Hormone (hGH) ng/mL 2.61 1.83 – 3.39 8.15 5.70 – 10.6 13.7 9.62 – 17.9
Insulin µIU/mL 16.2 9.15 – 23.3 62.9 38.9 – 86.9 172 108 – 237
Luteinizing Hormone (LH) mIU/mL 1.42 0.850 – 1.99 21.6 18.4 – 24.8 89.3 73.8 – 105
Progesterone (II Gen) (310690) ng/mL 0.920 0.370 – 1.46 9.48 6.63 – 12.3 22.0 14.7 – 29.3
Prolactin (312151) µIU/mL 152 116 – 188 435 370 – 500 914 777 – 1051
Prolactin (xt) µIU/mL 152 116 – 188 435 370 – 500 914 777 – 1051
PSA (Free) ng/mL 0.210 0.120 – 0.300 1.22 1.04 – 1.40 9.92 8.43 – 11.4
PSA (Total) ng/mL 0.540 0.360 – 0.720 1.93 1.60 – 2.26 17.5 14.9 – 20.1
T3 (Free) (Revised) pg/mL 2.49 1.93 – 3.05 9.36 7.91 – 10.8 21.2 16.1 – 26.4
T3 (Total) (Revised) ng/dL 74.3 38.9 – 110 174 111 – 237 305 221 – 389
T4 (Free) (Revised) ng/dL 0.930 0.780 – 1.08 3.21 2.59 – 3.83 6.14 4.92 – 7.36
T4 (Free) (US only) (Revised) ng/dL 0.930 0.780 – 1.08 3.21 2.59 – 3.83 6.14 4.92 – 7.36
T4 (Total) µg/dL 4.14 3.00 – 5.28 7.76 5.68 – 9.84 11.1 8.11 – 14.1
Testosterone ng/mL 1.13 0.720 – 1.53 3.56 2.49 – 4.62 5.66 3.96 – 7.36
Thyroid Stimulating Hormone (TSH) (Revised) µIU/mL 0.500 0.380 – 0.620 5.77 4.89 – 6.65 32.6 27.6 – 37.6
DIASORIN LIAISON XL (2)
ACTH pg/mL 52.7 42.4 – 63.0 133 90.0 – 176 281 235 – 327
AFP IU/mL 15.4 13.1 – 17.7 84.4 70.7 – 98.1 174 148 – 200
Aldosterone ng/dL 9.77 6.84 – 12.7 19.6 13.7 – 25.4 57.3 40.1 – 74.5
Calcitonin pg/mL 31.7 22.2 – 41.2 144 101 – 188 241 169 – 313
CEA ng/mL 2.49 2.12 – 2.86 17.4 14.7 – 20.1 40.3 34.2 – 46.4
Cortisol µg/dL 2.10 1.71 – 2.49 18.4 14.2 – 22.6 34.5 27.6 – 41.4
C-Peptide ng/mL 2.01 1.63 – 2.39 7.25 6.16 – 8.34 8.38 7.12 – 9.64
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 62.6 41.8 – 83.4 137 95.6 – 178 522 364 – 680

Page 15 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
DIASORIN LIAISON XL (2) (continued)
Estradiol (II Gen) (310680) pg/mL 72.3 48.5 – 96.2 191 134 – 248 355 248 – 461
Ferritin ng/mL 64.9 55.2 – 74.6 141 120 – 162 331 281 – 381
Follicle Stimulating Hormone (FSH) mIU/mL 10.0 8.42 – 11.6 37.7 31.3 – 44.1 75.7 63.3 – 88.1
Follicle Stimulating Hormone (FSH) (US only) mIU/mL 7.93 6.50 – 9.36 28.7 23.6 – 33.8 58.0 49.3 – 66.7
hCG (XL hCG) (REF 312321) mIU/mL 5.12 2.83 – 7.41 21.3 17.6 – 25.0 184 156 – 212
Human Growth Hormone (hGH) ng/mL 2.61 1.83 – 3.39 8.15 5.70 – 10.6 13.7 9.62 – 17.9
Insulin µIU/mL 16.2 9.15 – 23.3 62.9 38.9 – 86.9 172 108 – 237
Luteinizing Hormone (LH) (Revised) mIU/mL 1.84 1.21 – 2.47 23.3 19.7 – 26.9 97.2 82.1 – 112
Progesterone (II Gen) (310690) ng/mL 0.840 0.330 – 1.34 9.03 6.32 – 11.7 21.3 14.3 – 28.3
Prolactin (312151) µIU/mL 152 106 – 198 425 331 – 519 883 669 – 1097
Prolactin (xt) µIU/mL 152 106 – 198 425 331 – 519 883 669 – 1097
PSA (Free) ng/mL 0.170 0.100 – 0.240 1.20 0.990 – 1.41 9.76 8.30 – 11.2
PSA (Total) ng/mL 0.570 0.420 – 0.720 2.12 1.80 – 2.44 18.6 15.6 – 21.6
T3 (Free) (Revised) pg/mL 2.54 2.05 – 3.03 9.87 8.17 – 11.6 21.0 15.4 – 26.6
T3 (Total) ng/dL 67.4 47.1 – 87.7 147 103 – 191 270 205 – 335
T4 (Free) (Revised) ng/dL 1.02 0.820 – 1.22 3.63 2.96 – 4.30 7.15 5.84 – 8.46
T4 (Free) (US only) (Revised) ng/dL 1.02 0.820 – 1.22 3.63 2.96 – 4.30 7.15 5.84 – >7.70
T4 (Total) (Revised) µg/dL 3.92 2.51 – 5.33 7.07 5.05 – 9.09 9.74 6.86 – 12.6
Testosterone ng/mL 0.950 0.610 – 1.29 3.08 2.15 – 4.00 4.55 3.19 – 5.92
Thyroid Stimulating Hormone (TSH) (Revised) µIU/mL 0.580 0.450 – 0.710 6.57 5.10 – 8.04 35.5 28.4 – 42.6
Fujirebio LUMIPULSE G Series (2)
AFP (AFP-N) ng/mL 17.3 13.9 – 20.7 96.5 77.2 – 116 208 166 – 250
CEA (CEA-N) ng/mL 2.70 2.20 – 3.20 20.8 16.7 – 24.9 46.6 37.3 – 55.9
C-Peptide (Serum, Plasma) ng/mL 1.19 0.960 – 1.42 4.84 3.88 – 5.80 5.30 4.24 – 6.36
Estradiol (E2-III) pg/mL 89.9 72.0 – 108 259 207 – 310 565 452 – 678
Ferritin (N) ng/mL 42.0 33.6 – 50.4 102 81.2 – 122 258 207 – 310
Follicle Stimulating Hormone (FSH) (Product No. 230923) mIU/mL 6.20 5.00 – 7.40 22.3 17.9 – 26.7 40.3 32.3 – 48.3
Follicle Stimulating Hormone (FSH) (Product No. 292693) mIU/mL 7.90 6.40 – 9.40 27.9 22.4 – 33.4 50.1 40.1 – 60.1
hCG (Beta) mIU/mL 4.10 3.30 – 4.90 19.7 15.8 – 23.6 162 130 – 194
Immunoglobulin E (IgE) IU/mL 333 266 – 400 114 90.9 – 136 146 116 – 175
Insulin (N) µIU/mL 15.0 12.0 – 18.0 57.4 46.0 – 68.8 159 127 – 191
Luteinizing Hormone (LH) mIU/mL 1.20 1.00 – 1.40 15.2 12.2 – 18.2 50.8 40.7 – 60.9
Progesterone (PRG-N) ng/mL 0.710 0.570 – 0.850 9.92 7.94 – 11.9 24.2 19.4 – 29.0
Prolactin ng/mL 8.50 6.80 – 10.2 23.1 18.5 – 27.7 47.3 37.9 – 56.7
PSA (Free) ng/mL 0.193 0.155 – 0.231 0.927 0.742 – 1.11 8.71 6.97 – 10.5
PSA (Total) (PSA-N) ng/mL 0.600 0.480 – 0.720 1.84 1.47 – 2.20 15.4 12.3 – 18.5
T3 (Free) (III) pg/mL 2.84 2.28 – 3.40 7.74 6.20 – 9.28 15.0 12.0 – 18.0
T3 (Total) ng/mL 0.850 0.680 – 1.02 2.10 1.68 – 2.52 4.12 3.30 – 4.94
T4 (Free) (N) ng/dL 0.780 0.630 – 0.930 2.44 1.96 – 2.92 4.53 3.63 – 5.43
T4 (Total) µg/dL 5.51 4.41 – 6.61 13.0 10.4 – 15.6 19.6 15.7 – 23.6
Testosterone ng/mL 2.04 1.64 – 2.44 6.01 4.81 – 7.21 10.4 8.32 – 12.5
Thyroid Stimulating Hormone (TSH) (TSHIII) µIU/mL 0.366 0.293 – 0.439 4.43 3.54 – 5.32 23.7 19.0 – 28.5
IDS-iSYS (2)
Human Growth Hormone (hGH) (IS-3700) ng/mL 2.93 2.14 – 3.72 9.13 6.94 – 11.3 15.4 12.2 – 18.7
LSI MEDIENCE (2)
Carbamazepine (LPIA) µg/mL <2.00 7.40 5.90 – 8.80 13.4 10.7 – 16.1
Digoxin (LPIA) ng/mL 0.700 0.600 – 0.900 1.90 1.50 – 2.30 3.40 2.70 – 4.10
Phenobarbital (LPIA) µg/mL 11.5 9.20 – 13.8 29.4 23.5 – 35.3 54.1 43.2 – 64.9
Phenytoin (LPIA) µg/mL 6.30 5.00 – 7.50 14.1 11.3 – 16.9 28.0 22.4 – 33.6
Theophylline (LPIA) µg/mL 3.10 2.50 – 3.70 13.0 10.4 – 15.6 25.0 20.0 – 30.0
Valproic Acid (LPIA) µg/mL 28.8 23.0 – 34.6 64.7 51.8 – 77.7 100 80.0 – 120
ORTHO VITROS MICROSLIDE SERIES
Acetaminophen (ACET) µg/mL <10.0 – 11.4 39.0 36.1 – 41.9 121 113 – 129
Carbamazepine (CRBM) µg/mL <3.00 7.17 5.44 – 8.90 12.0 9.05 – 14.9
Digoxin (DGXN) ng/mL 0.800 <0.400 – 1.23 1.75 1.27 – 2.23 3.13 2.63 – 3.64

Page 16 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ORTHO VITROS MICROSLIDE SERIES (continued)
Iron (Fe) µg/dL 102 81.7 – 122 85.6 65.6 – 106 82.1 62.0 – 102
Lithium (Li) mmol/L 0.717 0.484 – 0.949 1.68 1.44 – 1.93 2.28 2.00 – 2.56
Phenytoin (PHYT) µg/mL 6.05 4.66 – 7.44 11.7 9.38 – 14.1 22.0 18.2 – 25.8
Salicylate (SALI) mg/dL 4.51 4.13 – 4.89 17.3 13.6 – 20.9 35.3 26.5 – >40.0
Theophylline (THEO) µg/mL 3.45 2.02 – 4.88 13.3 10.7 – 15.9 27.9 23.4 – 32.4
ORTHO VITROS MICROTIP SERIES
Gentamicin (GENT) µg/mL 2.18 1.64 – 2.71 4.24 3.48 – 5.01 5.89 4.86 – 6.92
Tobramycin (TOBRA) µg/mL 1.04 0.759 – 1.31 2.72 2.30 – 3.13 5.58 4.79 – 6.37
Valproic Acid (VALP) µg/mL 32.2 21.5 – 42.9 69.5 54.4 – 84.6 104 83.6 – 125
Vancomycin (VANC) µg/mL 6.16 <5.00 – 7.74 15.3 12.5 – 18.1 27.8 23.0 – 32.6
ORTHO VITROS MICROWELL SERIES
AFP (2) (3) IU/mL 13.7 10.9 – 16.5 80.3 64.6 – 96.0 168 131 – 205
CEA ng/mL 2.52 1.71 – 3.33 18.2 14.6 – 21.8 42.7 33.9 – 51.5
Cortisol (Cort) µg/dL 2.83 2.07 – 3.59 16.1 12.0 – 20.3 25.0 18.6 – 31.4
Estradiol (E2) (2) pg/mL 77.7 30.0 – 125 298 188 – 408 741 468 – 1015
Ferritin (Ferr) ng/mL 50.3 37.5 – 63.1 100 75.7 – 125 252 191 – 312
Folate (Fol/RCFol) ng/mL 3.23 1.72 – 4.73 9.03 5.34 – 12.7 16.1 9.94 – >20.0
Follicle Stimulating Hormone (FSH) (2) mIU/mL 5.00 3.75 – 6.25 19.0 15.4 – 22.6 35.9 28.2 – 43.6
hCG (B-hCG) mIU/mL 10.4 7.82 – 12.9 26.6 21.6 – 31.6 240 204 – 276
Insulin (2) (3) µIU/mL 14.6 9.26 – 19.9 55.9 38.8 – 73.0 156 108 – 204
Luteinizing Hormone (LH) mIU/mL 0.920 0.351 – 1.49 17.3 14.3 – 20.2 57.4 46.9 – 68.0
Progesterone (Prog) (2) ng/mL 0.673 0.371 – 0.975 9.43 7.01 – 11.9 27.7 21.3 – 34.1
Prolactin (Prol) ng/mL 8.70 5.34 – 12.1 19.8 10.8 – 28.9 35.2 23.8 – 46.5
PSA (Free) (fPSA) (2) ng/mL 0.183 0.105 – 0.261 0.950 0.696 – 1.20 8.82 6.52 – 11.1
PSA (Total) (PSA) ng/mL 0.624 0.442 – 0.806 1.77 1.36 – 2.18 12.1 9.82 – 14.4
PSA (Total) (tPSA) (2) ng/mL 0.624 0.457 – 0.791 2.06 1.51 – 2.61 18.1 13.1 – 23.1
T3 (Free) (FT3 II) (2) pg/mL 4.42 3.31 – 5.53 13.2 10.8 – 15.6 >22.7
T3 (Free) (FT3) (2) pg/mL 4.53 3.33 – 5.72 15.3 12.4 – 18.2 >22.7
T3 (Total) (TT3) ng/mL 0.929 0.712 – 1.15 1.99 1.50 – 2.48 3.55 2.62 – 4.48
T3 Uptake/T Uptake (T3U) % Uptake 36.2 29.5 – 42.9 48.3 37.4 – 59.2 54.7 41.8 – >65.0
T4 (Free) (FT4) ng/dL 1.27 0.740 – 1.79 5.86 5.18 – 6.53 >6.98
T4 (Total) (TT4) (2) µg/dL 5.32 4.31 – 6.33 12.2 10.1 – 14.3 17.1 14.2 – 19.9
Testosterone (Testo) (2) ng/dL 151 95.7 – 206 680 487 – 873 1294 925 – 1663
Thyroid Stimulating Hormone (TSH) µIU/mL 0.315 0.230 – 0.400 4.89 3.95 – 5.83 27.5 21.6 – 33.3
Vitamin B12 pg/mL 355 233 – 477 617 455 – 778 795 621 – 968
PerkinElmer AUTODELFIA (2)
AFP (hAFP) ng/mL 16.9 13.3 – 20.5 90.4 72.3 – 108 189 152 – 227
Estriol (Free) (Unconjugated, uE3) ng/mL 2.48 1.73 – 3.17 5.76 4.03 – 7.49 13.8 11.0 – >14.4
Follicle Stimulating Hormone (FSH) (hFSH) mIU/mL 5.90 4.70 – 7.10 22.0 18.0 – 26.0 42.0 34.0 – 50.0
hCG mIU/mL 9.10 6.40 – 12.0 22.0 17.0 – 28.0 213 170 – 256
Luteinizing Hormone (LH) (hLH) mIU/mL 1.30 1.00 – 1.60 17.0 14.0 – 20.0 55.0 44.0 – 66.0
Prolactin ng/mL 4.30 3.20 – 5.40 12.0 9.60 – 14.0 26.0 21.0 – 31.0
PSA (Free) (ProStatus) ng/mL 0.260 0.210 – 0.310 1.20 0.960 – 1.40 11.0 8.80 – 13.0
PSA (Total) (ProStatus) ng/mL 0.650 0.520 – 0.780 2.10 1.70 – 2.50 17.0 14.0 – 21.0
T3 (Total) ng/mL 1.60 0.880 – 2.30 3.20 2.60 – 3.80 5.20 4.20 – 6.20
T4 (Free) ng/dL 1.09 0.760 – 1.40 4.88 3.88 – 5.89 >6.20
T4 (Total) µg/dL 5.43 3.80 – 7.05 11.2 8.91 – 13.4 15.2 12.2 – 18.2
Thyroid Stimulating Hormone (TSH) (hTSH Ultra) µIU/mL 0.430 0.340 – 0.520 5.20 4.20 – 6.20 31.0 25.0 – 37.0
PerkinElmer DELFIA Xpress (2)
AFP (hAFP) ng/mL 15.7 12.0 – 19.3 88.0 69.9 – 106 188 151 – 225
Estriol (Free) (Unconjugated, uE3) ng/mL 2.33 1.64 – 3.17 5.76 4.03 – 7.49 >14.4
hCG mIU/mL 7.20 5.00 – 9.40 21.0 16.0 – 26.0 192 154 – 230
ROCHE / HITACHI COBAS C SYSTEMS
Acetaminophen (ACET2) (REF 06769942190) µg/mL 8.53 6.08 – 11.0 30.9 25.1 – 36.8 97.2 80.0 – 114
Acetaminophen (ACETA) (REF 20767174160) µg/mL

Page 17 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ROCHE / HITACHI COBAS C SYSTEMS (continued)
Acetaminophen (ACETA) (REF 20767174322) µg/mL
Amikacin µg/mL 4.35 3.06 – 5.64 12.8 11.1 – 14.4 24.0 21.5 – 26.4
Carbamazepine (CARB3) µg/mL 2.62 1.62 – 3.63 7.34 5.59 – 9.10 11.9 9.64 – 14.2
Digoxin ng/mL 0.682 0.420 – 0.944 2.00 1.63 – 2.37 3.93 3.49 – 4.37
Ferritin ng/mL 65.8 54.7 – 77.0 111 89.2 – 132 239 185 – 292
Gentamicin (GENT2) µg/mL 1.46 0.369 – 2.55 2.89 1.82 – 3.96 4.08 3.06 – 5.10
Gentamicin (QMS) µg/mL 2.11 0.923 – 3.30 4.23 2.65 – 5.80 6.13 4.49 – 7.76
Iron µg/dL 95.6 80.5 – 111 87.6 74.1 – 101 84.4 71.1 – 97.7
Iron (TIBC) µg/dL 255 186 – 324 246 181 – 311 257 193 – 320
Lithium mg/dL 0.349 0.305 – 0.393 0.887 0.814 – 0.959 1.32 1.23 – 1.41
Phenobarbital µg/mL 9.33 7.62 – 11.0 23.4 20.2 – 26.7 46.7 41.4 – 52.0
Phenytoin µg/mL 6.48 5.01 – 7.96 12.6 10.0 – 15.2 24.1 19.9 – 28.2
Salicylate mg/dL 3.64 2.98 – 4.30 15.8 13.9 – 17.7 43.9 38.8 – 49.0
Theophylline µg/mL 4.40 3.62 – 5.18 14.2 12.2 – 16.2 26.4 23.2 – 29.5
Tobramycin µg/mL 1.04 0.707 – 1.36 3.12 2.71 – 3.54 6.13 5.43 – 6.82
Valproic Acid µg/mL 34.7 25.7 – 43.7 75.9 60.6 – 91.2 112 91.7 – 133
Vancomycin µg/mL 6.21 4.42 – 8.00 17.1 13.3 – 20.8 30.8 24.5 – 37.1
ROCHE COBAS INTEGRA
Acetaminophen (ACET2) µg/mL 9.05 6.55 – 11.6 31.0 25.3 – 36.8 99.4 77.4 – 121
Acetaminophen (ACETA) µg/mL <15.0 27.9 22.6 – 33.3 95.7 83.7 – 108
Amikacin µg/mL 4.60 2.75 – 6.45 13.5 10.4 – 16.6 23.7 19.2 – 28.2
Carbamazepine µg/mL 2.60 2.22 – 2.98 7.20 6.31 – 8.09 11.9 10.4 – 13.3
Digoxin ng/mL 0.680 0.390 – 0.970 1.80 1.23 – 2.38 3.32 2.32 – 4.31
Gentamicin µg/mL 2.31 1.84 – 2.78 4.28 3.46 – 5.09 5.88 4.75 – 7.00
Immunoglobulin A (IgA) mg/dL 172 158 – 186 162 138 – 185 169 152 – 186
Immunoglobulin G (IgG) mg/dL 765 697 – 834 788 688 – 888 790 687 – 892
Immunoglobulin M (IgM) mg/dL 56.4 48.7 – 64.1 67.6 59.2 – 76.0 63.3 54.8 – 71.8
Lithium mEq/L 0.555 0.216 – 0.895 1.46 1.11 – 1.81 2.34 1.99 – 2.69
Phenobarbital µg/mL 9.38 8.16 – 10.6 22.7 20.4 – 25.0 45.5 41.2 – 49.7
Phenytoin µg/mL 6.27 5.49 – 7.05 12.8 10.9 – 14.6 24.3 20.9 – 27.7
Salicylate mg/dL 4.06 3.07 – 5.05 15.6 13.5 – 17.7 42.7 38.7 – 46.6
Theophylline µg/mL 4.37 3.45 – 5.28 14.2 12.5 – 15.9 27.2 24.4 – 30.0
Tobramycin µg/mL 0.707 0.406 – 1.01 2.64 2.11 – 3.17 5.30 4.46 – 6.14
Valproic Acid µg/mL 32.4 28.1 – 36.8 71.1 63.1 – 79.0 110 99.5 – 120
Vancomycin µg/mL 7.73 6.07 – 9.38 20.2 17.0 – 23.5 36.2 30.9 – 41.5
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (2)
ACTH pg/mL 24.1 16.9 – 31.4 41.6 29.1 – 54.1 100 70.0 – 130
AFP ng/mL 17.5 12.2 – 22.7 106 74.3 – 139 218 153 – 283
Calcitonin pg/mL 48.6 34.0 – 63.2 241 169 – 313 416 291 – 541
CEA ng/mL 2.68 2.04 – 3.32 17.5 13.8 – 21.2 37.0 29.2 – 44.8
Cortisol µg/dL 3.09 2.16 – 4.02 19.5 13.7 – 25.3 30.0 21.0 – 38.9
Cortisol (II) µg/dL 3.39 2.37 – 4.42 17.0 11.9 – 22.1 26.1 18.3 – 33.9
C-Peptide ng/mL 1.59 1.21 – 1.97 5.90 4.48 – 7.32 6.88 5.23 – 8.53
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 91.1 69.2 – 113 187 142 – 232 659 501 – 817
Digoxin (Ref. 11820796) restand. ng/mL 0.633 0.481 – 0.785 1.76 1.34 – 2.18 3.46 2.63 – 4.29
Estradiol (III) pg/mL 79.9 55.9 – 104 209 146 – 271 413 289 – 537
Ferritin ng/mL 78.0 59.3 – 96.7 152 115 – 188 344 261 – 426
Folate (III) (E170/e601/e602) (Ref. 07559992) (Europe/Asia) restand. ng/mL 2.61 1.44 – 3.78 8.00 4.40 – 11.6 14.0 9.07 – 18.8
Folate (III) (E170/e601/e602) (Ref. 07559992) restand. ng/mL 2.61 <2.00 – 3.78 8.00 4.40 – 11.6 14.0 9.07 – 18.8
Folate (III) (e411) (Ref. 07559992) (Europe/Asia) restand. ng/mL 2.48 1.36 – 3.60 8.01 4.41 – 11.6 14.2 9.20 – 19.1
Folate (III) (e411) (Ref. 07559992) restand. ng/mL 2.48 <2.00 – 3.60 8.01 4.41 – 11.6 14.2 9.20 – 19.1
Follicle Stimulating Hormone (FSH) mIU/mL 6.67 4.67 – 8.67 23.9 16.7 – 31.1 44.5 31.1 – 57.8
hCG (+ ß) mIU/mL 4.87 3.26 – 6.48 19.0 12.7 – 25.2 186 125 – 248
hCG (STAT) mIU/mL 5.39 3.61 – 7.17 18.6 12.4 – 24.7 182 122 – 242
Human Growth Hormone (hGH) ng/mL 2.69 1.75 – 3.63 8.23 6.17 – 10.3 14.5 10.9 – 18.1

Page 18 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS (2) (continued)
Immunoglobulin E (IgE) ng/mL 940 743 – 1136 310 243 – 374 388 307 – 469
Insulin µIU/mL 16.8 12.8 – 20.9 64.5 49.0 – 79.9 178 135 – 220
Luteinizing Hormone (LH) mIU/mL 1.75 1.33 – 2.17 19.9 15.1 – 24.6 62.9 47.8 – 78.0
Progesterone ng/mL 0.504 0.277 – 0.731 10.3 6.60 – 14.0 30.3 19.4 – 41.2
Progesterone (III) ng/mL 0.750 0.413 – 1.09 10.2 6.50 – 13.8 26.2 16.8 – 35.6
Prolactin ng/mL 9.58 7.28 – 11.9 25.3 19.2 – 31.3 54.1 41.1 – 67.1
PSA (Free) ng/mL 0.233 0.177 – 0.289 1.13 0.893 – 1.37 10.1 7.96 – 12.2
PSA (Total) ng/mL 0.731 0.556 – 0.906 2.35 1.79 – 2.91 19.1 14.5 – 23.6
T3 Total ng/mL 1.02 0.714 – 1.32 2.07 1.57 – 2.57 3.38 2.56 – 4.19
T3 Uptake/T-Uptake TBI 0.978 0.773 – 1.18 0.655 0.517 – 0.793 0.394 0.276 – 0.512
T3 (Free) pg/mL 2.77 1.94 – 3.60 7.27 5.50 – 8.96 14.0 10.6 – 17.3
T3 (Free) (III) pg/mL 2.79 1.95 – 3.63 7.21 5.49 – 8.96 14.2 10.8 – 17.6
T4 Free ng/dL 1.02 0.806 – 1.24 2.91 2.30 – 3.53 5.08 3.71 – 6.44
T4 Total µg/dL 5.38 4.09 – 6.67 11.1 8.45 – 13.7 15.0 11.4 – 18.6
T4 (Free) (II) ng/dL 1.04 0.822 – 1.26 3.03 2.40 – 3.67 5.24 3.83 – 6.66
Testosterone (II) ng/mL 2.14 0.856 – 3.42 5.83 4.08 – 7.58 9.73 6.81 – 12.6
Thyroglobulin (Tg) ng/mL 8.72 6.63 – 10.8 9.87 7.50 – 12.2 9.89 7.52 – 12.3
Thyroglobulin (Tg) (II) ng/mL 6.80 4.96 – 8.64 8.02 5.85 – 10.2 8.16 5.96 – 10.4
Thyroid Stimulating Hormone (TSH) µIU/mL 0.491 0.373 – 0.609 5.88 4.65 – 7.11 33.9 26.8 – 41.0
Vitamin B12 II (E170/e601/e602) pg/mL 383 233 – 532 580 406 – 753 747 523 – 971
Vitamin B12 II (e411) pg/mL 373 228 – 519 560 392 – 728 747 523 – 972
Vitamin B12 (E170/e601/e602) pg/mL 372 227 – 517 569 399 – 740 734 514 – 954
Vitamin B12 (e411) pg/mL 364 222 – 506 565 395 – 734 734 514 – 954
ROCHE HITACHI / MODULAR
Carbamazepine µg/mL 2.62 1.62 – 3.63 7.34 5.59 – 9.10 11.9 9.64 – 14.2
Digoxin ng/mL 0.682 0.420 – 0.944 2.00 1.63 – 2.37 3.93 3.49 – 4.37
Gentamicin µg/mL 2.11 0.923 – 3.30 4.23 2.65 – 5.80 6.13 4.49 – 7.76
Iron µg/dL 94.0 89.3 – 98.7 85.8 81.2 – 90.3 81.8 77.3 – 86.3
Phenobarbital µg/mL 9.33 7.62 – 11.0 23.4 20.2 – 26.7 46.7 41.4 – 52.0
Phenytoin µg/mL 6.48 5.01 – 7.96 12.6 10.0 – 15.2 24.1 19.9 – 28.2
Theophylline µg/mL 4.40 3.62 – 5.18 14.2 12.2 – 16.2 26.4 23.2 – 29.5
Tobramycin µg/mL 1.04 0.707 – 1.36 3.12 2.71 – 3.54 6.13 5.43 – 6.82
Valproic Acid µg/mL 34.7 25.7 – 43.7 75.9 60.6 – 91.2 112 91.7 – 133
SIEMENS ADVIA CENTAUR CP
AFP ng/mL 18.8 13.8 – 23.8 102 71.5 – 133 210 146 – 273
Carbamazepine (CARB) µg/mL 2.63 1.48 – 3.77 7.33 5.21 – 9.46 11.5 8.43 – 14.6
CEA ng/mL 2.08 1.12 – 3.04 15.4 10.6 – 20.1 34.9 23.3 – 46.4
Cortisol (COR) µg/dL 3.16 2.18 – 4.14 18.7 13.3 – 24.2 29.5 20.9 – 38.0
C-Peptide (CpS) ng/mL 1.16 0.618 – 1.69 4.80 3.00 – 6.59 5.59 3.78 – 7.40
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 68.5 49.0 – 88.0 139 104 – 174 461 354 – 568
Digoxin (DIG) ng/mL 0.700 0.498 – 0.903 2.05 1.67 – 2.43 3.69 3.14 – 4.24
Estradiol (eE2) pg/mL 82.8 53.5 – 112 326 235 – 416 743 548 – 937
Ferritin (FER) ng/mL 57.5 39.9 – 75.1 126 87.5 – 164 306 212 – 400
Folate (FOL) ng/mL 3.64 1.93 – 5.36 9.49 5.74 – 13.2 14.9 8.81 – 20.9
Follicle Stimulating Hormone (FSH) mIU/mL 5.73 4.33 – 7.13 23.4 18.3 – 28.5 47.8 37.6 – 58.1
Gentamicin (GENT) µg/mL 1.98 1.34 – 2.62 4.05 2.86 – 5.23 6.22 4.23 – 8.22
hCG (ThCG) mIU/mL 7.25 5.15 – 9.35 23.4 17.9 – 28.9 181 142 – 220
Immunoglobulin E (IgE) (IgEJ) IU/mL 349 262 – 436 105 78.8 – 131 145 109 – 181
Immunoglobulin E (IgE) (tIgE) IU/mL 349 209 – 489 105 63.0 – 147 145 87.0 – 203
Insulin (IRI) (For use with Rgt. Lots ending 169-174 and Cal. Lots
C6659-C6674) (Revised) µIU/mL 21.1 13.7 – 28.5 72.4 51.7 – 93.1 224 164 – 284
Insulin (IRI) (For use with Rgt. Lots ending 201 and future lots and Cal
Lots C6602 and future lots) (2) µIU/mL 16.3 12.6 – 20.0 56.7 43.7 – 69.7 167 129 – 205
Luteinizing Hormone (LH) mIU/mL 1.45 1.11 – 1.78 16.2 13.0 – 19.5 57.8 45.7 – 69.9
Phenobarbital (PHNB) µg/mL 9.53 7.37 – 11.7 23.2 16.0 – 30.5 45.9 30.8 – 61.0
Phenytoin (PHTN) µg/mL 6.94 5.11 – 8.77 14.0 10.4 – 17.6 26.8 20.4 – 33.2

Page 19 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR CP (continued)
Progesterone (PRGE) ng/mL 1.05 0.325 – 1.78 8.67 6.48 – 10.9 20.4 15.7 – 25.0
Prolactin (PRL) ng/mL 5.71 4.46 – 6.96 14.4 11.1 – 17.7 32.1 24.5 – 39.6
PSA (Total) (PSA) ng/mL 0.586 0.416 – 0.756 1.77 1.35 – 2.19 15.4 11.1 – 19.7
T3 (Free) (FT3) pg/mL 2.81 2.39 – 3.22 6.16 5.42 – 6.91 10.2 8.79 – 11.6
T3 (Total) (T3) ng/mL 0.982 0.885 – 1.08 2.21 2.07 – 2.35 3.83 3.60 – 4.06
T3 Uptake/T Uptake (TUp) T Uptake Unit 1.20 1.00 – 1.40 1.59 1.33 – 1.85 1.74 1.46 – 2.02
T4 (Free) (FT4) ng/dL 0.891 0.691 – 1.09 2.32 1.84 – 2.79 3.76 3.01 – 4.52
T4 (Total) (T4) µg/dL 5.39 4.06 – 6.72 13.3 10.6 – 16.0 17.8 14.2 – 21.3
Testosterone (TSTO) ng/dL 161 119 – 204 443 344 – 541 761 597 – 925
Theophylline (THEO2) µg/mL 4.70 2.97 – 6.42 14.1 10.6 – 17.6 25.3 19.3 – 31.3
Thyroid Stimulating Hormone (TSH) µIU/mL 0.615 0.237 – 0.993 6.95 3.46 – 10.4 38.0 18.9 – 57.1
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.380 0.149 – 0.612 4.53 2.15 – 6.90 25.4 12.2 – 38.6
Valproic Acid (VALP) µg/mL 35.2 27.8 – 42.5 72.6 59.0 – 86.1 106 85.6 – 127
Vancomycin (VANC) µg/mL 4.87 2.16 – 7.57 13.5 8.86 – 18.2 24.5 17.2 – 31.8
Vitamin B12 (VB12) pg/mL 358 256 – 460 557 425 – 688 741 581 – 902
SIEMENS ADVIA CENTAUR SYSTEMS
AFP ng/mL 18.9 14.9 – 22.9 102 84.3 – 120 212 173 – 250
Carbamazepine (CARB) µg/mL 2.86 1.89 – 3.84 7.64 5.46 – 9.83 11.9 8.63 – 15.1
CEA ng/mL 2.04 1.33 – 2.75 16.5 13.1 – 19.8 38.2 30.7 – 45.8
Cortisol (COR) µg/dL 2.94 1.89 – 4.00 17.8 13.0 – 22.6 28.0 19.7 – 36.3
C-Peptide (CpS) ng/mL 1.13 0.741 – 1.52 4.93 3.40 – 6.46 5.88 4.13 – 7.64
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEAS) µg/dL 66.6 43.8 – 89.3 134 96.8 – 171 460 331 – 590
Digoxin (DIG) ng/mL 0.772 0.523 – 1.02 2.04 1.62 – 2.45 3.73 3.12 – 4.34
Estradiol (eE2) (Revised) (2) pg/mL 82.0 65.6 – 98.4 285 228 – 342 696 557 – 835
Ferritin (FER) (Revised) ng/mL 61.3 47.7 – 75.0 136 104 – 167 343 250 – 435
Folate (FOL) (Revised) ng/mL 3.20 2.04 – 4.36 7.39 3.76 – 11.0 12.7 6.13 – 19.3
Follicle Stimulating Hormone (FSH) mIU/mL 6.76 5.56 – 7.97 26.6 21.9 – 31.3 55.1 45.3 – 64.8
Gentamicin (GENT) µg/mL 2.06 1.55 – 2.57 4.03 3.07 – 4.99 5.98 4.52 – 7.44
hCG (ThCG) mIU/mL 7.87 4.15 – 11.6 22.8 17.4 – 28.3 178 149 – 206
Immunoglobulin E (IgE) (IgEJ) IU/mL 352 264 – 440 113 84.8 – 141 147 110 – 184
Immunoglobulin E (IgE) (tIgE) IU/mL 355 213 – 497 114 68.4 – 160 149 89.4 – 209
Insulin (IRI) (For use with Rgt. Lots ending 169-174 and Cal. Lots
C6659-C6674) (Revised) µIU/mL 21.7 16.0 – 27.4 73.8 57.0 – 90.6 232 182 – 282
Insulin (IRI) (For use with Rgt. Lots ending 201 and future lots and Cal
Lots C6 602 and future lots) (2) µIU/mL 16.5 12.7 – 20.3 58.2 44.8 – 71.6 166 128 – 204
Luteinizing Hormone (LH) mIU/mL 1.30 1.04 – 1.56 17.4 14.2 – 20.5 59.1 48.0 – 70.1
Phenobarbital (PHNB) (Revised) µg/mL 11.4 9.15 – 13.6 27.0 20.9 – 33.1 53.1 41.2 – 65.0
Phenytoin (PHTN) µg/mL 6.79 5.08 – 8.49 14.1 10.9 – 17.3 27.6 21.5 – 33.7
Progesterone (PRGE) ng/mL 1.00 0.455 – 1.55 9.22 7.08 – 11.4 21.9 17.4 – 26.4
Prolactin (PRL) ng/mL 5.81 4.84 – 6.77 15.3 12.5 – 18.1 35.2 28.4 – 41.9
PSA (Free) (fPSA) ng/mL 0.236 0.173 – 0.298 1.06 0.908 – 1.21 9.70 8.42 – 11.0
PSA (Total) (PSA) ng/mL 0.594 0.464 – 0.724 1.88 1.57 – 2.19 15.5 12.8 – 18.2
T3 (Free) (FT3) pg/mL 2.65 2.30 – 3.01 6.48 5.67 – 7.28 11.0 9.66 – 12.3
T3 (Total) (T3) ng/mL 0.908 0.655 – 1.16 2.07 1.66 – 2.49 3.75 3.08 – 4.41
T3 Uptake/T Uptake (TUp) (%) % Uptake § § §
T3 Uptake/T Uptake (TUp) (Unit) T Uptake Unit 1.10 0.847 – 1.35 1.41 0.995 – 1.83 1.50 1.18 – 1.83
T4 (Free) (FT4) ng/dL 0.852 0.672 – 1.03 2.21 1.76 – 2.66 3.36 2.55 – 4.17
T4 (Total) (T4) µg/dL 5.42 4.13 – 6.70 12.6 9.94 – 15.3 17.5 14.0 – 21.1
Testosterone (TSTII) ng/dL 245 170 – 319 502 350 – 654 774 556 – 992
Testosterone (TSTO) (Revised) ng/dL 155 113 – 197 446 319 – 573 766 567 – 966
Theophylline (THEO2) µg/mL 4.30 2.24 – 6.36 14.0 10.5 – 17.5 25.9 20.0 – 31.9
Thyroid Stimulating Hormone (TSH) (Lots 001281 and below) µIU/mL 0.471 0.257 – 0.685 6.00 3.77 – 8.22 37.1 23.5 – 50.6
Thyroid Stimulating Hormone (TSH) (Lots 001282 and above) (2) µIU/mL 0.508 0.394 – 0.622 6.52 5.08 – 7.97 36.0 28.0 – 44.0
Thyroid Stimulating Hormone (TSH) (TSH3-UL) µIU/mL 0.388 0.189 – 0.587 4.65 2.90 – 6.40 25.9 16.4 – 35.5
Valproic Acid (VALP) µg/mL 32.8 26.7 – 39.0 69.1 57.5 – 80.8 103 86.0 – 119
Vancomycin (VANC) µg/mL 4.82 3.35 – 6.30 13.5 10.5 – 16.5 24.6 19.2 – 29.9

Page 20 English • 2017-01 • 1536-00

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
SIEMENS ADVIA CENTAUR SYSTEMS (continued)
Vitamin B12 (VB12) pg/mL 350 248 – 452 554 420 – 687 746 577 – 916
SIEMENS ADVIA CHEMISTRY SYSTEMS
Acetaminophen (ACET) mg/dL 0.982 0.750 – 1.21 3.33 2.78 – 3.88 10.2 8.67 – 11.7
Carbamazepine (CARB_2) µg/mL 3.10 2.08 – 4.12 8.33 6.67 – 9.99 12.8 9.78 – 15.8
Digoxin (DIG) ng/mL 0.635 0.249 – 1.02 1.79 1.42 – 2.15 3.34 2.95 – 3.72
Ferritin (FRT) ng/mL 59.3 49.0 – 69.5 111 91.1 – 130 233 189 – 278
Gentamicin (GENT_2) µg/mL 2.03 1.48 – 2.59 4.07 3.23 – 4.90 5.95 4.87 – 7.03
Immunoglobulin A (IgA) (IGA_2) mg/dL 190 176 – 204 183 169 – 197 191 177 – 206
Immunoglobulin G (IgG) (IGG_2) mg/dL 777 722 – 832 804 750 – 858 794 740 – 848
Immunoglobulin M (IgM) (IGM_2) mg/dL 57.3 52.8 – 61.7 67.3 62.3 – 72.2 63.1 58.2 – 68.0
Iron (IRON_2) µg/dL 101 95.7 – 105 86.8 82.9 – 90.8 82.2 78.5 – 85.8
Lithium (LITH) mEq/L 0.523 0.409 – 0.638 1.24 1.06 – 1.42 1.87 1.57 – 2.16
Phenobarbital (PHNB_2) µg/mL 9.63 6.91 – 12.4 23.9 16.6 – 31.1 47.1 33.5 – 60.7
Phenytoin (PHNY_2) µg/mL 6.15 4.51 – 7.79 12.6 9.16 – 16.1 23.8 17.7 – 30.0
Salicylate (SAL) mg/dL 3.14 <1.00 – 5.30 16.3 12.4 – 20.1 47.1 39.0 – 55.1
Theophylline (THEO_2) µg/mL 4.65 2.82 – 6.48 14.8 9.82 – 19.8 28.0 18.1 – 38.0
Tobramycin (TOB_2) µg/mL 0.683 0.404 – 0.962 2.83 2.34 – 3.32 5.42 4.70 – 6.13
Valproic Acid (VPA_2) µg/mL 36.2 26.7 – 45.6 79.2 62.2 – 96.2 120 94.8 – 145
Vancomycin (VANC_2) µg/mL 7.35 5.00 – 9.70 17.3 12.5 – 22.1 29.0 22.1 – 36.0
SIEMENS BN SERIES NEPHELOMETERS
Immunoglobulin A (IgA) mg/dL 193 175 – 212 170 148 – 192 178 157 – 198
Immunoglobulin E (IgE) IU/mL 355 316 – 394 105 89.0 – 121 135 115 – 155
Immunoglobulin G (IgG) mg/dL 790 697 – 884 800 689 – 911 801 685 – 917
Immunoglobulin M (IgM) mg/dL 70.5 58.7 – 82.2 73.2 60.8 – 85.6 67.4 57.4 – 77.4
SIEMENS DIMENSION SERIES
Acetaminophen (ACTM) µg/mL 11.3 8.00 – 14.7 38.3 33.7 – 42.8 115 107 – 123
Carbamazepine (CRBM) µg/mL
Digoxin (DGNA) ng/mL 0.607 0.398 – 0.815 1.81 1.52 – 2.10 3.30 2.88 – 3.72
Ferritin (FERR) ng/mL 66.8 49.0 – 84.7 132 104 – 159 305 248 – 363
Folate (FOLA) (EXL LOCI MODULE) (RF644) ng/mL 2.34 1.52 – 3.15 6.10 4.15 – 8.05 10.2 6.87 – 13.5
Gentamicin (GENT) µg/mL 1.97 1.53 – 2.40 4.22 3.58 – 4.86 6.08 5.30 – 6.87
hCG mIU/mL 8.17 6.12 – 10.2 22.3 18.3 – 26.4 225 189 – 260
Immunoglobulin A (IgA) mg/dL 159 138 – 179 149 126 – 173 155 132 – 177
Immunoglobulin G (IgG) mg/dL 738 639 – 837 744 616 – 873 734 649 – 819
Immunoglobulin M (IgM) mg/dL 55.2 42.1 – 68.4 63.5 50.1 – 76.8 61.1 48.8 – 73.4
Iron µg/dL
Iron (TIBC) µg/dL
Lithium (LI) mmol/L 0.414 0.280 – 0.549 1.22 1.03 – 1.40 1.85 1.64 – 2.07
Phenobarbital (PHNO) µg/mL 9.87 6.13 – 13.6 23.7 18.8 – 28.6 47.0 39.0 – 55.0
Phenytoin (PTN) µg/mL 6.10 4.27 – 7.93 13.2 10.3 – 16.1 25.3 21.1 – 29.4
PSA (Free) (FPSA) ng/mL 0.210 0.146 – 0.274 1.05 0.903 – 1.20 10.6 9.31 – 11.9
PSA (Total) (TPSA) ng/mL 0.628 0.457 – 0.800 1.99 1.63 – 2.35 17.9 15.3 – 20.5
Salicylate (SAL) mg/dL 4.32 3.39 – 5.25 16.3 14.5 – 18.0 43.3 39.9 – 46.6
T3 (Free) (FT3) pg/mL 2.62 2.11 – 3.13 7.81 7.05 – 8.58 15.2 14.0 – 16.4
T3 Uptake/T Uptake (%, TU) % Uptake 32.7 27.7 – 37.6 39.2 32.5 – 45.8 42.3 35.9 – 48.8
T4 (Free) (EXL LOCI Module) ng/dL 0.924 0.717 – 1.13 2.53 1.97 – 3.10 5.54 4.27 – 6.81
T4 (Free) (Heterogeneous Module) ng/dL 0.657 0.346 – 0.968 2.97 2.18 – 3.75 4.97 3.67 – 6.27
T4 (Total) (T4) µg/dL
Theophylline (THEO) µg/mL 4.18 3.33 – 5.04 14.1 11.4 – 16.8 25.0 19.2 – 30.7
Thyroid Stimulating Hormone (TSH) µIU/mL 0.360 0.261 – 0.459 4.56 3.38 – 5.74 28.0 20.3 – 35.8
Thyroid Stimulating Hormone (TSH) (EXL LOCI Module) (TSHL) µIU/mL 0.388 0.292 – 0.484 5.16 3.83 – 6.49 31.8 22.4 – 41.3
Tobramycin (TOBR) µg/mL 0.467 0.152 – 0.781 2.30 1.81 – 2.79 4.95 4.16 – 5.74
Valproic Acid (VALP) µg/mL 35.9 30.4 – 41.4 72.9 61.1 – 84.6 106 87.7 – 123
Vancomycin (VANC) µg/mL 5.77 4.26 – 7.28 16.5 13.6 – 19.4 30.9 25.8 – 36.0
Vitamin B12 (VB12) (EXL LOCI MODULE) (RF642) pg/mL 366 263 – 469 557 422 – 691 708 543 – 872

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
SIEMENS DIMENSION VISTA SYSTEMS
Acetaminophen (ACTM) µg/mL 14.1 10.0 – 18.2 41.5 35.7 – 47.3 118 108 – 129
AFP ng/mL 16.4 13.9 – 18.9 91.4 80.8 – 102 200 179 – 221
Amikacin µg/mL 4.52 2.87 – 6.17 14.0 9.66 – 18.3 24.6 17.3 – 32.0
Caffeine µg/mL 2.00 1.32 – 2.68 7.13 5.16 – 9.10 14.6 10.5 – 18.6
Carbamazepine (CRBM) µg/mL 2.60 2.00 – 3.19 7.43 6.40 – 8.45 12.2 10.8 – 13.7
CEA ng/mL 2.10 1.78 – 2.42 17.6 15.3 – 19.9 39.9 34.9 – 45.0
Digoxin (DGXN) ng/mL 0.685 0.588 – 0.782 1.81 1.64 – 1.97 3.57 3.33 – 3.80
Estradiol pg/mL 80.3 58.9 – 102 243 203 – 283 495 436 – 554
Ferritin (FERR) ng/mL 55.0 45.8 – 64.2 113 94.5 – 131 268 226 – 310
Folate (FOL) ng/mL 2.05 1.38 – 2.72 5.17 3.91 – 6.42 8.88 6.85 – 10.9
Follicle Stimulating Hormone (FSH) mIU/mL 6.49 5.80 – 7.18 22.7 20.7 – 24.7 39.4 36.2 – 42.7
Gentamicin (GENT) µg/mL 2.18 1.48 – 2.88 4.58 3.58 – 5.59 6.65 5.67 – 7.63
hCG (Beta, BHCG) mIU/mL 8.00 7.19 – 8.81 21.2 18.9 – 23.5 208 188 – 228
Immunoglobulin A (IgA) mg/dL 191 176 – 206 171 157 – 184 176 162 – 190
Immunoglobulin E (IgE) IU/mL 357 328 – 386 102 88.6 – 116 133 118 – 149
Immunoglobulin G (IgG) mg/dL 815 744 – 887 818 744 – 892 810 741 – 879
Immunoglobulin M (IgM) mg/dL 68.6 60.3 – 76.9 72.6 65.3 – 80.0 67.4 59.2 – 75.5
Iron µg/dL 193 48.2 – 338 172 42.8 – 301 162 40.4 – 284
Iron (TIBC) µg/dL 307 284 – 330 301 279 – 322 316 289 – 343
Lidocaine (LIDO) µg/mL 1.42 1.20 – 1.63 3.80 3.46 – 4.14 6.78 6.28 – 7.28
Lithium (LITH) mmol/L 0.467 0.345 – 0.588 1.22 1.05 – 1.40 1.86 1.64 – 2.08
Luteinizing Hormone (LH) mIU/mL 1.28 0.904 – 1.66 19.4 17.1 – 21.8 72.5 64.3 – 80.6
N-Acetyl Procainamide (NAPA) µg/mL 1.55 1.06 – 2.04 4.44 3.33 – 5.56 9.49 7.05 – 11.9
Phenobarbital (PHNO) µg/mL 10.1 6.97 – 13.3 24.3 20.1 – 28.6 46.3 40.4 – 52.1
Phenytoin (PTN) µg/mL 6.93 5.47 – 8.39 13.9 11.3 – 16.4 25.7 21.5 – 29.9
Procainamide (PROC) µg/mL 2.09 1.73 – 2.46 9.08 4.96 – 13.2 14.2 6.89 – >20.0
Progesterone (PROG) ng/mL 1.04 0.614 – 1.46 9.21 6.54 – 11.9 23.5 16.5 – 30.5
Prolactin (PRL) ng/mL 6.05 5.29 – 6.81 18.2 16.3 – 20.1 40.1 35.9 – 44.4
PSA (Free) (FPSA) ng/mL 0.212 0.168 – 0.256 1.04 0.900 – 1.19 9.92 8.43 – 11.4
PSA (Total) (TPSA) ng/mL 0.621 0.504 – 0.737 1.92 1.72 – 2.12 16.1 14.6 – 17.5
Salicylate (SAL) mg/dL 4.70 3.95 – 5.45 16.9 15.4 – 18.3 44.7 42.0 – 47.4
T3 (Free) (FT3) pg/mL 2.25 1.84 – 2.66 7.23 6.55 – 7.91 14.4 13.3 – 15.4
T3 Uptake/T Uptake (%, TU) % Uptake 32.7 27.0 – 38.3 40.7 33.6 – 47.8 45.7 37.9 – 53.4
T4 (Free) (FT4) ng/dL 0.911 0.748 – 1.07 2.37 1.99 – 2.75 5.08 4.35 – 5.80
T4 (Total) (T4) µg/dL 6.10 4.13 – 8.07 13.7 11.1 – 16.3 19.0 15.3 – 22.7
Theophylline (THEO) µg/mL 4.26 3.33 – 5.19 14.2 11.8 – 16.6 26.3 22.1 – 30.5
Thyroid Stimulating Hormone (TSH) µIU/mL 0.385 0.313 – 0.457 5.25 4.35 – 6.14 31.6 25.1 – 38.0
Tobramycin (TOBR) µg/mL 0.483 0.302 – 0.665 2.37 1.85 – 2.88 5.12 3.86 – 6.38
Valproic Acid (VALP) µg/mL 34.1 27.5 – 40.7 71.3 60.3 – 82.2 107 91.4 – 122
Vancomycin (VANC) µg/mL 6.40 4.89 – 7.91 17.4 14.5 – 20.2 29.7 25.1 – 34.2
Vitamin B12 (VB12) pg/mL 359 264 – 453 545 432 – 659 698 576 – 820
SIEMENS IMMULITE / IMMULITE 1000
AFP ng/mL 16.8 11.7 – 21.8 96.1 65.3 – 127 211 148 – 275
Androstenedione ng/mL 0.767 <0.300 – 1.38 2.49 1.17 – 3.80 4.07 2.25 – 5.89
CEA ng/mL 2.91 1.99 – 3.84 23.5 18.1 – 29.0 53.0 41.4 – 64.6
Cortisol µg/dL 3.63 2.52 – 4.74 18.5 13.4 – 23.5 27.9 21.1 – 34.7
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) µg/dL 59.9 41.4 – 78.4 128 84.8 – 171 485 359 – 611
Estradiol pg/mL 86.6 59.4 – 114 287 215 – 358 632 481 – 783
Estriol (Free) (UE3) ng/mL 1.38 0.503 – 2.25 4.30 2.29 – 6.31 7.04 – >11.2
Ferritin ng/mL 64.2 48.9 – 79.4 117 88.1 – 145 267 198 – 337
Follicle Stimulating Hormone (FSH) mIU/mL 7.06 5.62 – 8.51 25.5 20.0 – 31.0 50.2 38.6 – 61.7
hCG mIU/mL 9.29 4.95 – 13.6 24.3 15.8 – 32.8 269 185 – 354
hCG (Turbo) mIU/mL 10.5 6.01 – 15.1 25.0 16.2 – 33.8 269 183 – 355
Human Growth Hormone (hGH) (LKGRH) ng/mL 2.88 1.53 – 4.23 8.60 5.03 – 12.2 14.8 8.79 – 20.9
Luteinizing Hormone (LH) mIU/mL 1.31 0.954 – 1.66 16.6 12.5 – 20.7 53.6 38.9 – 68.3

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

INSTRUMENT (1)
Level 1 - 40341 Level 2 - 40342 Level 3 - 40343
Units Mean Range Mean Range Mean Range
SIEMENS IMMULITE / IMMULITE 1000 (continued)
Progesterone (LKPW1) ng/mL 0.905 0.595 – 1.22 8.89 6.16 – 11.6 21.7 14.6 – 28.8
Prolactin ng/mL 8.05 6.14 – 9.97 20.4 15.8 – 24.9 44.8 35.4 – 54.1
PSA (Free) ng/mL 0.185 0.097 – 0.273 0.925 0.701 – 1.15 8.27 6.38 – 10.2
PSA (Total) ng/mL 0.603 0.123 – 1.08 2.27 1.36 – 3.17 19.1 12.6 – 25.7
PSA (Total) (Gen. 3) ng/mL 0.462 0.089 – 0.834 1.68 1.12 – 2.23 13.5 9.64 – 17.4
T3 (Free) pg/mL 2.78 1.63 – 3.93 5.75 4.16 – 7.35 9.60 7.34 – 11.9
T3 (Total) ng/dL 65.5 <40.0 – 97.7 181 133 – 229 320 231 – 408
T3 Uptake/T Uptake % Uptake 29.6 24.3 – 34.9 37.2 30.5 – 44.0 43.2 34.5 – 51.9
T4 (Free) ng/dL 1.17 0.944 – 1.39 3.13 2.53 – 3.73 5.10 4.13 – >6.00
T4 (Total) µg/dL 4.96 3.46 – 6.46 12.5 9.27 – 15.7 16.2 11.7 – 20.8
Testosterone ng/dL 162 94.8 – 228 673 433 – 914 927 – >1600
Thyroid Stimulating Hormone (TSH) (Gen. 3) µIU/mL 0.427 0.322 – 0.531 5.06 3.74 – 6.38 27.0 19.8 – 34.1
Thyroid Stimulating Hormone (TSH) (Rapid) µIU/mL 0.437 0.336 – 0.537 5.03 3.78 – 6.28 27.5 20.4 – 34.5
Vitamin B12 pg/mL 378 280 – 476 603 424 – 781 772 545 – 998
SIEMENS IMMULITE 2000 / 2000 XPi
ACTH pg/mL 38.3 19.6 – 57.1 125 77.4 – 173 338 221 – 455
AFP ng/mL 15.7 10.0 – 21.3 93.3 61.9 – 125 193 124 – 261
Androstenedione ng/mL 0.807 <0.300 – 1.41 2.83 1.57 – 4.09 4.78 2.75 – 6.80
Calcitonin pg/mL 36.7 13.4 – 60.0 180 119 – 242 314 230 – 398
Carbamazepine µg/mL 2.36 1.56 – 3.15 6.55 4.98 – 8.13 10.4 8.22 – 12.6

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.
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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