NIH, National Cancer Institute, Division of Cancer Treatment and Diagnosis (DCTD) NIH - National Institutes of Health National Cancer Institute DCTD - Division of Cancer Treatment and Diagnosis

Evaluation of haemoglobin A1c measurement by an enzymatic method using an automated analyser that has an on-board haemolysis system.

Author(s): Matsumoto H, Uchino M, Kato M

Publication: Ann Clin Biochem, 2013, Vol. 50, Page 443-9

PubMed ID: 23897101 PubMed Review Paper? No

Purpose of Paper

The purpose of this paper was to determine the effects of sampling location within the erythrocyte pack and quantification method on levels of glycated hemoglobin (HbA1C) in blood.

Conclusion of Paper

Regardless of sampling location relative to the bottom of the tube, measured levels of HbA1C were comparable when measured by the enzymatic assay based Bio Majesty (BM)6010/C or the high-performance liquid-chromatography (HPLC) based Tosoh G7. The authors report no effect of exogenous acetylated hemoglobin (Hb), carbamylated Hb or labile HbA1c on measurement of HbA1c. Levels of HbA1c measured by the BM6010/C were very strongly correlated with those measured by the Primus HPLC and Tosoh G7 HPLC, but a bias of 0.6-3.3% was observed using the BM6010/C.

Studies

  1. Study Purpose

    The purpose of this study was to determine the effects of sampling location within the erythrocyte pack and measurement method on levels of HbA1C in blood from inpatients, outpatients and hospital employees.

    Summary of Findings:

    Regardless of sampling location relative to the bottom of the tube, measured levels of HbA1C were comparable when by the enzymatic assay based BM6010/C and the HPLC based Tosoh G7. The authors report no effect of exogenous acetylated Hb, carbamylated Hb and labile HbA1c on measurement of HbA1c. Levels of HbA1c measured by the BM6010/C were very strongly correlated with those measured by the Primus HPLC (r2=0.997) and Tosoh G7 HPLC (r=0.994), but a bias of 0.6-3.3% was observed using the BM6010/C.

    Biospecimens
    Preservative Types
    • None (Fresh)
    Diagnoses:
    • Normal
    • Not specified
    Platform:
    AnalyteTechnology Platform
    Protein Clinical chemistry/auto analyzer
    Protein HPLC
    Pre-analytical Factors:
    ClassificationPre-analytical FactorValue(s)
    Biospecimen Aliquots and Components Biospecimen components 1 mm from bottom
    3 mm from bottom
    5 mm from bottom
    0-500 mg/L acetylated Hb added
    0-500 mg/L carbamylated Hb added
    0-10 g/L labile HbA1c added
    Clinical chemistry/auto analyzer Specific Technology platform Tosoh G7 HPLC
    BM6010/C
    Primus HPLC
    Biospecimen Aliquots and Components Blood and blood products Multiple sampling positions examined

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