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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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- 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
|0.5 mL||7 day reconstituted stability at 2-8°C||3 year shelf life at 2-8°C||Bilevel & Bilevel MiniPak||Standard vial|
- 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.
Frequently Asked Questions
- 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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