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Am J Clin Pathol ; 129(4): 540-7, 2008 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-18343780

RESUMO

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.


Assuntos
Análise Química do Sangue/normas , Hemoglobinas Glicadas/análise , Laboratórios/normas , Controle de Qualidade , Viés , Análise Química do Sangue/estatística & dados numéricos , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Valor Preditivo dos Testes , Reprodutibilidade dos Testes
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