Analytic bias among certified methods for the measurement of hemoglobin A1c
Analytic bias among certified methods for the measurement of hemoglobin A1c
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DOI：
10.1309/u3gpptcbp1vll8aw
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发表时间：
2008-04-01
影响因子：
3.5
通讯作者：
Kahn, Stephen E.
中科院分区：
文献类型：
--
作者：
Holmes, Earle W.;Ersahin, Cagatay;Kahn, Stephen E.
我们研究了在我们的护理点（POC）和中心实验室（CL）测量血红蛋白A(1c) （HbA(1c)）的方法之间出现的分析偏差的幅度、意义和来源，并评估了7种常用的HbA（1c）方法相对于国家血红蛋白标准化计划（NGSP）参考方法的分析准确性。通过临床标本的分裂样本分析和33个月期间报告的HbA（1c）结果的时间序列分析，比较POC和CL方法。7种HbA（1c）方法的相对准确性使用美国病理学家学会熟练度调查结果进行评估。CL-和POC-分析试验结果的长期漂移导致中位方法间偏差[（POC结果）- （CL结果）]从-0.4%增加到-0.9% HbA（1c）。在7种ngsp认证的HbA（1c）方法中，经常观察到系统偏差、分析性能随时间的漂移以及方法间的可变性。当HbA（1c）结果相对于通用的、固定的临床决策阈值进行解释时，方法间的可变性是不准确的潜在来源。
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 A(1c) (HbA(1c)) and evaluated the analytic accuracy of 7 commonly used HbA(1c) 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 HbA(1c) results reported for a 33-month period. The relative accuracies of 7 HbA(1c) 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% HbA(1c). Systematic biases, drifts in analytic performance over time, and intermethod variability were frequently observed among the 7 NGSP-certified HbA(1c) methods. Intermethod variability is a potential source of inaccuracy whenever HbA(1c) results are interpreted relative to universal, fixed, clinical decision thresholds.