Lyphochek Quantitative Urine Control

Normal (1) and Abnormal (2)

376 Normal (1) 12 x 10 mL Level 1 63511
377 Abnormal (2) 12 x 10 mL 2024-11-30 63510 Level 2 63512
375X Bilevel MiniPak 2 x 10 mL

https://www.myeinserts.com/63510

INTENDED USE LIMITATIONS

Lyphochek Quantitative Urine Control is intended for use as an assayed quality control 1. This product should not be used past the expiration date.
urine to monitor the precision of laboratory testing procedures for the analytes listed in this 2. If there is evidence of microbial contamination or excessive turbidity in the
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 the 4. For Laboratory/Professional Use Only
precision of methods and techniques in use and is an integral part of good laboratory WARNING
practices. Multiple levels of control are available to allow monitoring of the test
system’s reliability. Biological source material. Treat as potentially infectious.
For customers in Germany: Quality control materials are required for assessment of The serum from each donor contributing urine for this product was tested as required by
laboratory performance as described in the “Guideline for Quality Assurance of Medical FDA accepted methods. Tests results were non-reactive or negative for evidence of
Laboratory Examinations following the German Medical Association” (Rili-BÄK regulation). infection due to Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis
REAGENT C Virus (HCV). This product may also contain other human source materials for which there
This product is prepared from human urine with added chemicals, constituents of human are no approved tests. In accordance with good laboratory practice, all human source
and animal origin, hormones, therapeutic drugs and stabilizers. This product is provided in material should be considered potentially infectious and handled with the same
lyophilized form for increased stability. precautions used with patient specimens.
STORAGE AND STABILITY Safety Data Sheet (SDS) available for professional users on www.bio-rad.com.
This product will be stable until the expiration date when stored unopened at 2 to 8°C. SPECIFIC PERFORMANCE CHARACTERISTICS
After reconstituting and storing tightly capped at 2 to 8°C, this product will be stable This product is a freeze-dried product manufactured under rigid quality control standards.
as follows: To obtain consistent assay values, the control requires proper storage and handling
- All analytes: 5 days as described.
Except: ASSIGNMENT OF VALUES
- Coproporphyrin, Dopamine, Epinephrine, Norepinephrine, Homovanillic Acid (HVA), The mean values and corresponding ±3SD ranges in the Assignment of Values Data Charts
Metanephrine, Metanephrine (Total), Porphyrins (Total), Uroporphyrin, 5-Aminolevulinic (available separately) were derived from replicate analyses and are specific for this lot of
Acid and Vanillylmandelic Acid (VMA): Assay immediately after reconstitution. product. Data from Unity™ Interlaboratory Program are included in the determination of
The stability of 5-Hydroxyindole Acetic Acid (5-HIAA), Dopamine, Epinephrine, some ranges. The tests listed were performed by the manufacturer and/or independent
Norepinephrine, Metanephrines, Homovanillic Acid (HVA), 5-Aminolevulinic Acid and laboratories using manufacturer supported reagents and a representative sampling of this
Vanillylmandelic Acid (VMA) may be extended to 30 days when the procedures for lot of product. It is recommended that each laboratory establish its own acceptable ranges
acidification are followed as described below and the vial is stored tightly capped at and use those provided only as guides. Laboratory established ranges may vary from those
2 to 8°C. After acidification, the control should only be used for the corresponding analytes. listed during the life of this control. [Customers in Germany have to follow the
• For 5-Hydroxyindole Acetic Acid (5-HIAA) and 5-Aminolevulinic Acid acidify with requirements as described in the Rili-BÄK regulation.] Variations over time and between
100.0 µL glacial acetic acid per 10.0 mL of reconstituted control. laboratories may be caused by differences in laboratory technique, instrumentation and
• For Metanephrines, Dopamine, Epinephrine, Norepinephrine, Homovanillic Acid (HVA) reagents, or by manufacturer test method modifications.
and Vanillylmandelic Acid (VMA), acidify with 80.0 µL 6M HCl per 10.0 mL of
reconstituted control or reconstitute the lyophilized control with 10 mL of 0.05M HCl. Unity™ Interlaboratory Program is a proprietary Bio-Rad software program holding more
This product is shipped under refrigerated conditions. than 2 billion QC data points from thousands of laboratories.
PROCEDURE INSTRUCTIONS FOR OBTAINING THE DATA CHARTS
This product should be treated the same as patient specimens and run in accordance with To obtain the Data Charts use the checkboxes on the Customize My eInserts page to select
the instructions accompanying the instrument, kit, or reagent being used. your chart items. You can View & Print your selections or Save Selections. Follow the
Using a volumetric pipet or equivalent, reconstitute each vial with 10.0 mL of distilled or directions on this website to receive email notifications of insert updates. Alternate
deionized water. Replace the stopper and allow the control to stand at room temperature methods for receiving data charts are available by contacting your local Bio-Rad
for at least 15 minutes, swirling occasionally. Before sampling, gently swirl the vial several Laboratories Office.
times to ensure homogeneity.
IMPORTANT PRODUCT INFORMATION
Safety Precautions
• Caution should be used when handling this product to prevent splashing. Wear
appropriate eye/face protection when using this product to protect from splashes. Significant changes are highlighted!
• If, during the use of this device or as a result of its use, a serious incident occurs, For this lot of control - No claims are made for expected values or stability of the
please report it to Bio-Rad Laboratories and to your national health authority, following analytes: 17-Ketosteroids, 17-OH-Corticosteroids and Hydroxyproline (Total).
as required.
• 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 • 2023-04 • 5140-00S

 Lyphochek Quantitative Urine Control, Normal (1) and Abnormal (2)
ANALYTES
11-Beta-Hydroxy-Androsterone ❑ Chloride Hydroxyproline (Total) ❑ ★ Pregnancy/hCG (Qualitative)
11-Beta-Hydroxy-Etiocholanolone ❑ Copper ❑ Iron ❍ Pregnanetriol ❑
11-Ketoandrosterone ❑ Coproporphyrin ❍ Lead ❍ Protein (Total)
11-Ketoetiocholanolone ❑ Cortisol Magnesium Sodium
17-Ketosteroids ❑ ★ Creatine ❑ Mercury ❍ Specific Gravity
17-OH-Corticosteroids ❑ ★ Creatinine Metanephrine Urea
3-Methoxytyramine ❍ Cystine ❑ Metanephrine (Total) ❍ Urea Nitrogen (BUN)
5-Aminolevulinic Acid ❍ Dehydroepiandrosterone (DHEA) ❑ Microalbumin Uric Acid
5-Hydroxy-Indoleacetic Acid (5-HIAA) Dopamine Norepinephrine ❍ Uroporphyrin ❍
Aldosterone Epinephrine ❍ Normetanephrine Vanillylmandelic Acid (VMA) ❍
AMP (Cyclic) ❑ Estriol (Total) ❑ Osmolality Zinc ❑
Androsterone ❑ Etiocholanolone ❑ pH
Arsenic ❍ Glucose Phosphorus
Barbiturate ❑ Homovanillic Acid (HVA) ❍ Porphyrins (Total) ❍
Calcium Hydroxyproline (Free) ❑ Potassium

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

Lyphochek is a trademark of Bio-Rad Laboratories in certain jurisdictions. Page 2 English • 2023-04 • 5140-00S
 Lyphochek Quantitative Urine Control, Normal (1) and Abnormal (2)

Revision Date 2024-08-12 Indicates Revised Information

METHOD (1)
Level 1 - 63511 (2) Level 2 - 63512 (2)
Units (3) Mean Range Mean Range
CALCIUM
Beckman Coulter AU Systems (Arsenazo III) mmol/L 0.908 0.792 – 1.02 2.83 2.53 – 3.12
CHLORIDE
Beckman Coulter AU Systems (ISE Indirect) mmol/L 48.9 45.5 – 52.4 256 242 – 269
CREATININE
Beckman Coulter AU Systems (Alkaline picrate-kinetic) mmol/L 7.02 5.90 – 8.15 19.2 16.2 – 22.3
GLUCOSE
Beckman Coulter AU Systems (Hexokinase) mmol/L 1.13 0.927 – 1.34 16.7 14.6 – 18.8
POTASSIUM
Beckman Coulter AU Systems (ISE Indirect) mmol/L 19.5 17.9 – 21.2 120 112 – 129
SODIUM
Beckman Coulter AU Systems (ISE Indirect) mmol/L 49.8 46.1 – 53.4 174 165 – 183
UREA NITROGEN (BUN) (5)
Beckman Coulter AU Systems (Urease, UV) mmol/L 130 113 – 147 258 228 – 288
URIC ACID
Beckman Coulter AU Systems (Uricase, colorimetric) mmol/L 0.594 0.506 – 0.681 1.32 1.15 – 1.50

FOOTNOTES
(1) All footnotes may not apply to your custom selected data chart.
(2) A dilution should be made prior to running those tests where the value listed exceeds the highest standard.
(3) All values expressed “per liter” are based on a 24-hour volume of 1 liter.
(4) The assigned values were determined using the reagent and/or instrument manufacturer’s protocol and may not represent ±3SD ranges.
(5) mg/dL Urea Nitrogen x 2.14 = mg/dL Urea. S.I. Units value range is expressed as Urea.
(6) “Positive” indicates a positive qualitative result. “Negative” indicates a negative qualitative result.
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 • 2023-04 • 5140-00S