Lyphochek Diabetes Control

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Overview

Human whole blood-based control used to monitor the assay precision of hemoglobin fractions associated with diabetes, including Hemoglobins A1, A1C, and F and Total Glycated Hemoglobin
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Description

Description

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Lyphochek Diabetes Control is a lyophilized, human whole blood-based control that is used to monitor the clinical assay precision of hemoglobin fractions associated with diabetes, including Hemoglobins A1, A1C, F, Total Glycated Hemoglobin and Total Hemoglobin. The product is provided in lyophilized form for ease of storage and increased stability. 

The control is available in two significant levels. Multiple levels allow for monitoring of test system reliability. The independent Lyphochek Diabetes Control monitors HbA1c and Total Hemoglobin test procedures, and it has value assignment listings for over 30 methods, including HPLC, immunoassay and point-of-care methodologies.

 

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Features  

  • Comprehensive menu of analytes—Contains five analytes for monitoring clinical hemoglobin test procedures associated with diabetes monitoring 
  • Patient-like material—Lyophilized, human whole blood–based control 
  • Multiple levels— Bilevel control offers monitoring of increased assay range   
  • Extensive value assignment listings—Allows for use of more than 30 testing methods on most major integrated HbA1c platforms to help help consolidate and streamline workflows 
  • Ease of use—Can be easily stored and offers increased stability 
  • Long shelf life—Reduces costly crossover studies which helps simplify workflow

 

Storage & Stability

Configuration Stability Shelf life Levels Format
0.5 mL 7 day reconstituted stability at 2-8°C 3 year shelf life at 2-8°C Bilevel & Bilevel MiniPak Standard vial

 

Analytes

  • Hemoglobin (Total Glycated)*
  • Hemoglobin (Total)
  • Hemoglobin A1*
  • Hemoglobin A1C
  • Hemoglobin F

* No claims are made regarding performance or stability.


Refer to My eInserts or the product insert (IFU) of currently available lots for specific analyte and stability claims, assay values, or additional data charts.

 

Applications & Use

This product should be treated the same as patient specimens and used in accordance with the instructions accompanying the instrument, kit, or reagent.

Using a volumetric pipette or equivalent, reconstitute each vial with 0.5 mL of distilled or deionized water. Replace the stopper and allow this product to stand for approximately 5 to 10 minutes, and swirl occasionally. Before sampling, gently swirl the vial several times to ensure homogeneity.

The reconstituted control exhibits column elution profiles and temperature sensitivities comparable to those of patient whole blood samples. Hemoglobin A1C results for the control must be corrected for temperature as recommended by the reagent manufacturer to achieve the assigned values.

 

Related Products

Immunoassay Controls 
Immunology/Protein Controls 
Hematology Controls 

 

Frequently Asked Questions

After use, how long can the control product be left out before return to refrigerator?
Typically, if the product has been stored refrigerated, allow the product to reach room temperature (18°C to 25°C) before use (specific time limitations may apply, depending on the product). For optimal analyte stability, promptly return the product to the recommended storage temperature after each use.
What type of water should be used to reconstitute lyophilized control products?
Typically, distilled or deionized water is used. Please refer to the product insert (IFU) for product specific diluent and reconstitution instructions.
How long should the reconstituted control remain at room temperature prior to use?
Upon reconstitution, the stopper should be replaced and the product should be allowed to stand at room temperature for the time period indicated in the product insert (IFU). Prior to use, gently swirl the vial to ensure homogeneity. Refer to the procedure section of the product insert (IFU) for product-specific handling instructions.
How long should frozen liquid controls sit at room temperature in order to thaw?
Typically, the frozen product should be allowed to thaw at room temperature (18°C to 25°C) for the time indicated in the package insert or until completely thawed prior to use. The product vial should be swirled gently to ensure homogeneity prior to use. Refer to the procedure section of the product insert (IFU) for product-specific handling instruction.
What are the acceptable limits for room, refrigerator, and freezer temperature?
This information is stated in the product insert (IFU):
  • Room temperature: 18°C to 25°C
  • Refrigerator temperature: 2-8°C
  • Freezer temperature: -20°C to -70°C/-20°C to -50°C for 2.5 mL vial

Most frozen products recommend avoidance of frost-free freezers. There are exceptions, so refer to specific control insert.

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740X
Assayed, lyophilized human whole blood based control for monitoring HbA1c for diabetes; MiniPak (2 x 0.5 mL)

Accessories

Accessories

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987000
Disposable plastic tip accessories for quality controls fitted with a screw cap closure. Enables fluid delivery directly from glass vial. 100/Package.

Documents

Documents

Number Description Options
Q-1520
Diabetes Controls and Lyphochek Hemoglobin A1C Linearity Set
[ Add to Cart (Free) ]
Q-1118
Quality Control Products & Services Catalog
[ Add to Cart (Free) ]