Analytic bias among certified methods for the measurement of hemoglobin A1c: a cause for concern?

Abstract:

:We studied the magnitude, significance, and origin of an analytic bias that emerged between our point-of-care (POC) and our central laboratory (CL) methods for the measurement of hemoglobin A1c (HbA1c) and evaluated the analytic accuracy of 7 commonly used HbA1c methods relative to the National Glycohemoglobin Standardization Program (NGSP) reference method. The POC and CL methods were compared by split-sample analysis of clinical specimens and time series analyses of the HbA1c results reported for a 33-month period. The relative accuracies of 7 HbA1c methods were evaluated using College of American Pathologists proficiency survey results. Long-term drifts in the CL- and POC-analyzed test results caused the median intermethod bias [(POC result)-(CL result)] to increase from -0.4% to -0.9% HbA1c. Systematic biases, drifts in analytic performance over time, and intermethod variability were frequently observed among the 7 NGSP-certified HbA1c methods. Intermethod variability is a potential source of inaccuracy whenever HbA1c results are interpreted relative to universal, fixed, clinical decision thresholds.

journal_name

Am J Clin Pathol

authors

Holmes EW,Erşahin C,Augustine GJ,Charnogursky GA,Gryzbac M,Murrell JV,McKenna KM,Nabhan F,Kahn SE

doi

10.1309/U3GPPTCBP1VLL8AW

subject

Has Abstract

pub_date

2008-04-01 00:00:00

pages

540-7

issue

4

eissn

0002-9173

issn

1943-7722

pii

U07173424X4313L2

journal_volume

129

pub_type

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