Lyphochek® Immunoassay Plus Control

Levels 1, 2 and 3
370 Trilevel 12 x 5 mL
Level 1 40431
371 Level 1 12 x 5 mL
0459 2025-10-31 40430 Level 2 40432
372 Level 2 12 x 5 mL
Level 3 40433
373 Level 3 12 x 5 mL
370X MiniPak 3 x 5 mL

https://www.myeinserts.com/40430

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/40430. 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) Testosterone

Angiotensin I ◆ ❑ Flecainide ❍ Netilmicin ❑ Testosterone (Free)

Anti-Thyroglobulin (Anti-Tg) ❑ Folate Nortriptyline ❍ Theophylline

Anti-Thyroperoxidase (Anti-TPO) ❑ Follicle Stimulating Hormone (FSH) Phenobarbital Thyroglobulin (Tg) ◆

Caffeine Fructosamine ◆ ❍ Phenytoin Thyroid Stimulating Hormone (TSH)

Calcitonin Gastrin Phenytoin (Free) ❍ Thyroxine Binding Globulin (TBG) ◆

Carbamazepine Gentamicin Primidone Tobramycin

Carbamazepine (Free) ❍ Glucagon ❑ Procainamide Tricyclic Antidepressants (TCA) ❍

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

Revision Date 2024-10-02 Indicates Revised Information

INSTRUMENT (1)
Level 1 - 40431 Level 2 - 40432 Level 3 - 40433
Units Mean Range Mean Range Mean Range
ROCHE ELECSYS / E170 / COBAS e SYSTEMS
ACTH pg/mL 24.4 8.25 – 40.5 79.6 38.6 – 121 156 80.1 – 231
AFP ng/mL 17.0 12.8 – 21.2 101 78.5 – 123 217 169 – 264
Calcitonin pg/mL 37.5 21.1 – 53.9 202 148 – 255 429 323 – 536
CEA ng/mL 2.39 1.84 – 2.94 17.7 14.6 – 20.7 33.7 28.0 – 39.5
Cortisol (II) µg/dL 2.98 2.28 – 3.68 17.3 13.9 – 20.8 26.3 21.2 – 31.4
C-Peptide ng/mL 1.73 1.35 – 2.11 5.28 4.32 – 6.24 8.08 6.67 – 9.49
Dehydroepiandrosterone-Sulfate (DHEA-Sulfate) (DHEA-Sulfate) µg/dL 99.1 75.6 – 123 217 171 – 263 776 621 – 931
Digoxin ng/mL 0.731 0.548 – 0.913 2.05 1.70 – 2.40 3.51 2.97 – 4.05
Estradiol (III) pg/mL 91.1 68.6 – 114 228 191 – 265 395 340 – 449
Ferritin ng/mL 80.0 64.9 – 95.1 204 165 – 244 437 351 – 523
Folate (cobas e801/e402) ng/mL 3.25 <2.00 – 4.50 7.65 5.56 – 9.74 14.5 11.1 – 17.8
Folate (III) (E170/e601/e602/e411) restand. ng/mL 3.01 <2.00 – 4.23 6.87 4.91 – 8.83 12.3 9.29 – 15.3
Follicle Stimulating Hormone (FSH) mIU/mL 7.47 6.16 – 8.78 20.2 16.7 – 23.8 38.7 31.9 – 45.5
hCG (+ ß) mIU/mL 4.92 3.77 – 6.06 20.1 16.4 – 23.8 223 185 – 260
hCG (STAT) mIU/mL 4.44 3.37 – 5.50 19.3 15.8 – 22.9 203 169 – 238
Human Growth Hormone (hGH) ng/mL 3.35 1.87 – 4.84 8.81 7.04 – 10.6 15.7 13.4 – 18.1
Immunoglobulin E (IgE) ng/mL 834 670 – 998 250 156 – 345 282 184 – 379
Insulin µIU/mL 16.8 13.7 – 19.8 63.1 53.1 – 73.1 188 160 – 217
Luteinizing Hormone (LH) mIU/mL 2.10 1.66 – 2.55 20.3 17.3 – 23.4 67.0 57.2 – 76.9
Progesterone (III) ng/mL 0.647 0.343 – 0.951 11.7 9.69 – 13.7 27.6 23.1 – 32.0
Prolactin ng/mL 8.77 7.33 – 10.2 24.0 20.1 – 27.9 51.2 42.9 – 59.5
Prostate Specific Antigen, Free (fPSA) (Cobas e411/e601/602) ng/mL 0.335 0.275 – 0.394 1.67 1.42 – 1.92 10.9 9.34 – 12.5
Prostate Specific Antigen, Free (fPSA) (Cobas e801/e402) ng/mL 0.329 0.274 – 0.385 1.64 1.38 – 1.90 10.5 8.84 – 12.2
Prostate Specific Antigen, Total (e411/e601/602) (tPSA) ng/mL 0.691 0.568 – 0.814 3.26 2.74 – 3.77 20.4 17.2 – 23.6
Prostate specific Antigen, Total (tPSA) (Cobas e801/e402) ng/mL 0.671 0.547 – 0.794 3.14 2.63 – 3.64 19.5 16.5 – 22.6
T3 Total ng/mL 1.04 0.787 – 1.29 2.46 1.94 – 2.98 3.66 2.91 – 4.41
T3 Uptake/T-Uptake TBI 0.966 0.836 – 1.10 0.591 0.419 – 0.763 0.338 <0.200 – 0.538
T3 (Free) (III) pg/mL 3.16 2.60 – 3.73 9.79 8.42 – 11.2 16.8 14.7 – 18.8
T4 Total µg/dL 5.98 4.70 – 7.26 10.4 8.22 – 12.5 13.2 10.4 – 15.9
T4 (Free) (II) ng/dL 1.14 1.01 – 1.27 2.99 2.44 – 3.53 4.92 3.94 – 5.90
T4 (Free) (III) ng/dL 1.22 1.07 – 1.37 3.25 2.65 – 3.85 5.50 4.40 – 6.59
Testosterone (II) ng/mL 1.55 1.15 – 1.95 4.17 3.35 – 4.99 8.79 7.23 – 10.4
Thyroid Stimulating Hormone (TSH) µIU/mL 0.517 0.352 – 0.683 6.36 5.02 – 7.71 36.7 29.2 – 44.1
Vitamin B12 (II) (E170/e601/e602/e411) pg/mL 413 324 – 502 624 512 – 737 869 729 – 1008
Vitamin B12 (II) (cobas e801/e402) pg/mL 382 296 – 467 607 496 – 717 824 689 – 959

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.
Data not applicable or not available.

Page 3 English • 2023-02 • 1536-00S