Effects of whole blood storage on hemoglobin a1c measurements with five current assay methods.

Author(s): Rohlfing CL, Hanson S, Tennill AL, Little RR

Publication: Diabetes Technol Ther, 2012, Vol. 14, Page 271-5

PubMed ID: 22032202 PubMed Review Paper? No

Purpose of Paper

Conclusion of Paper

Studies

1. Study Purpose

   The purpose of this study was to determine the effects of storage duration and temperature and assay type on levels of HbA1c in EDTA whole blood from 5 individuals. EDTA whole blood had initial values of 5-10% HbA1c. Stability was defined as within 3 standard deviations of all levels measured in specimens stored at -70 and a less than 0.2% change from previous time-point.

   Summary of Findings:

   Whole blood HbA1c levels were stable at -20 degrees C for at least 80 days when measured by the Siemans DCA 2000+, 10 days when measured by the Tosoh G7, 7 days when measured by Tosoh G8, 42 days when measured by Trinity Biotech ultra, and 6 days when measured by the BioRad Variant II. HbA1c levels were stable in whole blood stored at 4 degrees C for 28 days when measured by the Siemans DCA 2000+, 21 days when measured by the Tosoh G7 or G8, 42 days when measured by Trinity Biotech ultra, and 14 days when measured by the BioRad Variant II. HbA1c levels were stable in whole blood stored at room temperature for 14 days when measured by the Siemans DCA 2000+, 6 days when measured by the Tosoh G7 or G8, 9 days when measured by Trinity Biotech ultra, and 4 days when measured by the BioRad Variant II. However, HbA1c levels were only stable in whole blood stored for 1 day or less at 30 degrees C when measured by the Siemans DCA 2000+, the Tosoh G7 or G8, or the BioRad Variant II, but HbA1c was stable for 3 days at 30 degrees C when measured by the Trinity Biotech ultra. Further, HbA1c levels were stable in whole blood stored 1 day or less at 37 degrees C, regardless of assay type. An extra peak, before the HbA1c peak, began to appear in specimens subjected storage and evaluated by the Tosoh assays, and the peak was visible even in specimens with stable HbA1c levels.

   Biospecimens

   • Bodily Fluid - Blood

   Preservative Types

   • None (Fresh)
   • Other Preservative
   • Frozen

   Diagnoses:

   • Not specified

   Platform:

   Analyte	Technology Platform
   Protein	HPLC
   Protein	Hematology/ auto analyzer
   Protein	Immunoassay

   Pre-analytical Factors:

   Classification	Pre-analytical Factor	Value(s)
   Storage	Storage duration	0 days 1 day 2 days 3 days 4 days 6 days 7 days 10 days 14 days 21 days 28 days 42 days 56 days 84 days
   Hematology/ auto analyzer Specific	Technology platform	BioRad Variant Tosoh G7 Tosoh G8 Siemens DCA 2000+ Trinity Biotech Ultra
   Storage	Storage temperature	-70 degrees C -20 degrees C 4 degrees C Room temperature 30 degrees C 37 degrees C
   Biospecimen Preservation	Type of fixation/preservation	Frozen None (fresh) Refrigeration

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