Lyphochek Assayed Chemistry Control

Levels 1 and 2
C-310-5 Level 1 12 x 5 mL Level 1 89741
C-315-5 Level 2 12 x 5 mL 0459 2026-06-30 89740 Level 2 89742
313X MiniPak 2 x 5 mL

https://www.myeinserts.com/89740

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 Hazard (H) and Precautionary (P) Statements
for increased stability. EUH208 Contains Gentamicin, sulfate (salt) May produce an
STORAGE AND STABILITY allergic reaction.
This product will be stable until the expiration date when stored Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
unopened at 2 to 8°C. SPECIFIC PERFORMANCE CHARACTERISTICS
Reconstituted and Refrigerated: After reconstituting and storing tightly capped This product is a freeze-dried product manufactured under rigid quality control
at 2 to 8°C, this product will be stable as follows: standards. To obtain consistent assay values, the control requires proper storage
- All analytes: 7 days and handling as described.
Except: ASSIGNMENT OF VALUES
- T3 (Free), Acid Phosphatase (Total) and Prostatic Acid Phosphatase The mean values and corresponding ±3SD ranges in the Assignment of Values
(PAP): 3 days Data Charts (available separately) were derived from replicate analyses and are
Reconstituted and Frozen: When reconstituted and stored tightly capped specific for this lot of product. Data from Unity™ Interlaboratory Program are
at -10 to -20°C, this product will be stable as follows: included in the determination of some ranges. The tests listed were performed
- All analytes: 30 days by the manufacturer and/or independent laboratories using manufacturer
Except: supported reagents and a representative sampling of this lot of product. It is
- Tobramycin: 20 days recommended that each laboratory establish its own acceptable ranges and use
- T3 (Free): 10 days those provided only as guides. Laboratory established ranges may vary from
Once thawed, do not refreeze this product. Discard the remaining material. those listed during the life of this control. [Customers in Germany have to follow
This product is shipped under refrigerated conditions. the requirements as described in the Rili-BÄK regulation.] Variations over time
PROCEDURE and between laboratories may be caused by differences in laboratory technique,
This product should be treated the same as patient specimens and run in instrumentation and reagents, or by manufacturer test method modifications.
accordance with the instructions accompanying the instrument, kit, or reagent
being used. Unity™ Interlaboratory Program is a proprietary Bio-Rad software program
Using a volumetric pipet or equivalent, reconstitute each vial with 5.0 mL of holding more than 2 billion QC data points from thousands of laboratories.
distilled or deionized water. Replace the stopper and allow this product to stand INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
for approximately 20 minutes swirling occasionally. The Data Charts are available through the Internet, at
Before sampling, gently swirl the vial several times to ensure homogeneity. If www.myeinserts.com/89740. Follow the directions at the website to receive
performing trace metal analysis, do not mix by inversion. After each use, email notifications of insert updates. Alternate methods for receiving data charts
promptly replace the stopper and return to the appropriate storage condition. are available by contacting your local Bio-Rad Laboratories Office.
Dispose of any discarded materials in accordance with the requirements of your IMPORTANT PRODUCT INFORMATION
local waste management authorities. In the event of damage to packaging,
contact the local Bio-Rad Laboratories Sales Office or Bio-Rad Laboratories Significant changes are highlighted!
Technical Services. For this lot of control - No claims are made for expected values or stability of
the following analytes: LAP Arylamidase.

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 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.
★ See Important Product Information section.

LEXICON

Reconstitute with

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 Lyphochek Assayed Chemistry Control, Levels 1 and 2

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© 2023 Bio-Rad Laboratories Inc. Printed in the USA

Lyphochek is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 3 English • 2023-06 • 4030-00
 Lyphochek Assayed Chemistry Control, Levels 1 and 2

Revision Date 2024-03-28 Indicates Revised Information

INSTRUMENT (1)
Level 1 - 89741 Level 2 - 89742
Units Mean Range Mean Range
ERBA XL SERIES (5)
Albumin (India Market Only) g/dL 4.14 3.51 – 4.77 2.82 2.40 – 3.24
Alkaline Phosphatase (India Market Only) (2) U/L 139 112 – 166 553 442 – 664
ALT/SGPT (Modified IFCC) (India Market Only) (2) U/L 26.1 21.0 – 31.2 98.6 78.8 – 118
Amylase (2) U/L 58.7 47.0 – 70.4 377 302 – 452
AST/SGOT (Modified IFCC) (India Market Only) (2) U/L 41.6 33.2 – 50.0 215 173 – 257
Bilirubin (Direct) mg/dL 0.500 0.380 – 0.620 1.01 0.770 – 1.25
Bilirubin (Direct) (DCA) mg/dL 0.490 0.370 – 0.610 1.35 1.02 – 1.68
Bilirubin (Total) mg/dL 1.19 0.890 – 1.49 4.87 3.64 – 6.10
Bilirubin (Total) (DCA) mg/dL 1.21 0.910 – 1.51 4.83 3.63 – 6.03
Calcium (India Market Only) mg/dL 9.24 7.86 – 10.6 12.2 10.4 – 14.0
Chloride mEq/L 107 95.7 – 117 86.9 78.2 – 95.6
Cholesterol (HDL) (India Market Only) (7) mg/dL 80.5 64.3 – 96.7 27.0 21.6 – 32.4
Cholesterol (LDL) (India Market Only) mg/dL 121 97.0 – 145 57.5 46.1 – 68.9
Cholesterol (Total) mg/dL 240 204 – 276 94.6 80.5 – 109
Creatine Kinase (CK) (2) U/L 151 121 – 181 494 395 – 593
Creatinine (Alkaline picrate method) mg/dL 2.46 1.98 – 2.94 5.67 4.53 – 6.81
Creatinine (Enzymatic) mg/dL 1.68 1.35 – 2.01 5.28 4.23 – 6.33
Gamma Glutamyltransferase (GGT) (2) U/L 63.4 50.8 – 76.0 131 104 – 158
Glucose mg/dL 92.3 78.5 – 106 308 263 – 353
Glucose (Hexokinase) (India Market Only) mg/dL 98.2 83.5 – 113 292 247 – 337
Iron µg/dL 226 181 – 271 68.3 54.5 – 82.1
Iron (UIBC) µg/dL 80.4 64.2 – 96.6 129 102 – 156
Lactate Dehydrogenase (LDH) (2) U/L 338 269 – 407 857 686 – 1028
Lipase (2) U/L 57.4 46.0 – 68.8 80.7 64.5 – 96.9
Magnesium mg/dL 2.02 1.72 – 2.32 4.28 3.65 – 4.91
Phosphorus (India Market Only) mg/dL 3.78 3.21 – 4.35 7.08 6.03 – 8.13
Potassium mEq/L 3.71 3.35 – 4.07 5.81 5.24 – 6.38
Protein Serum (Total) g/dL 6.51 5.52 – 7.50 4.23 3.60 – 4.86
Sodium mEq/L 146 131 – 160 122 110 – 135
Triglycerides (India Market Only) mg/dL 164 140 – 188 78.6 66.9 – 90.3
Urea (4) mg/dL 34.0 28.9 – 39.1 96.9 82.5 – 111
Uric Acid mg/dL 5.17 4.39 – 5.95 10.7 9.20 – 12.2
Uric Acid (Single Reagent) mg/dL 6.41 5.45 – 7.37 10.2 8.70 – 11.7

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) Values were obtained at 37°C.
(3) The mean value is calculated from data generated by instruments using this method.
(4) mg/dL Urea Nitrogen x 2.14 = mg/dL Urea. S.I. Units value range is expressed as Urea.
(5) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(6) This product has been tested using the methodologies listed in the package insert. The performance of this product has not been evaluated for use with
capillary electrophoresis methods.
(7) Direct methods only.
(8) % Total Protein
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.

Lyphochek is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 3 English • 2023-06 • 4030-00