Lyphochek® Assayed Chemistry Control

Levels 1 and 2
C-310-5 Level 1 12 x 5 mL Level 1 26461
C-315-5 Level 2 12 x 5 mL 0459 2022-07-31 26460 Level 2 26462
313X MiniPak 2 x 5 mL

http://www.myeinserts.com/26460

INTENDED USE LIMITATIONS

Lyphochek Assayed Chemistry 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, purified potentially infectious and handled with the same precautions used with
biochemical material (tissue extracts of human and animal origin), therapeutic patient specimens.
drugs, stabilizers and preservatives. This product is provided in lyophilized form Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
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
- T3 (Free), Acid Phosphatase (Total) and Prostatic Acid Phosphatase included in the determination of some ranges. The tests listed were performed
(PAP): 3 days by the manufacturer and/or independent laboratories using manufacturer
Reconstituted and Frozen: When reconstituted and stored tightly capped supported reagents and a representative sampling of this lot of product. It is
at -10 to -20°C, this product will be stable as follows: recommended that each laboratory establish its own acceptable ranges and use
- All analytes: 30 days those provided only as guides. Laboratory established ranges may vary from
Except: those listed during the life of this control. [Customers in Germany have to follow
- Tobramycin: 20 days the requirements as described in the Rili-BÄK regulation.] Variations over time
- T3 (Free): 10 days 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/26460. 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 20 minutes swirling occasionally. are available by contacting your local Bio-Rad Laboratories Office.
Before sampling, gently swirl the vial several times to ensure homogeneity. If
performing trace metal analysis, do not mix by inversion. After each use,
promptly replace the stopper and return to the appropriate storage condition.
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 • 2019-05 • 4030-00

 Lyphochek® Assayed Chemistry Control, Levels 1 and 2
ANALYTES
Acetaminophen CEA ◆ Immunoglobulin A (IgA) ◆ Sodium
Acid Phosphatase (Total) Ceruloplasmin ◆ Immunoglobulin G (IgG) ◆ T3 (Free) ◆
AFP ◆ Chloride Immunoglobulin M (IgM) ◆ T3 (Total)
Albumin Cholesterol (HDL) Iron T3 Uptake/T Uptake
Alkaline Phosphatase Cholesterol (LDL) Iron (TIBC) ◆ T4 (Free) ◆
Alpha 1-Antitrypsin ◆ Cholesterol (Total) Iron (UIBC) ◆ T4 (Total)
Alpha-HBDH ◆ ❑ Cholinesterase ◆ Lactate (Lactic Acid) Theophylline
ALT/SGPT Complement C3 ◆ Lactate Dehydrogenase (LDH) Thyroid Stimulating Hormone (TSH)
Amylase Complement C4 ◆ ❑ LAP Arylamidase ◆ Thyroxine Binding Globulin (TBG) ◆ ❍
Amylase (Alpha) Copper ◆ Lipase Tobramycin
Amylase (Pancreatic) Cortisol Lithium Transferrin ◆
Apolipoprotein A-I ◆ Creatine Kinase (CK) Magnesium Triglycerides
Apolipoprotein B ◆ Creatinine Osmolality ◆ Urea
AST/SGOT Digoxin Phenobarbital Urea Nitrogen (BUN)
Bilirubin (Direct) Gamma Glutamyltransferase (GGT) Phenytoin Uric Acid
Bilirubin (Indirect) Gentamicin Phosphorus Valproic Acid
Bilirubin (Total) Globulin ◆ Potassium Vancomycin
Calcium Glucose Prostatic Acid Phosphatase (PAP) ❍ Vitamin B12 ◆
Calcium (Ionized) ◆ Glutamate Dehydrogenase (GLDH) ◆ Protein Serum (Total) Zinc ◆
Carbamazepine Haptoglobin ◆ PSA (Total) ◆
Carbon Dioxide (CO2) hCG-Beta Subunit ◆ Salicylate

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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