Sobolesky Philip M, Smith Breland E, Saenger Amy K, Schulz Karen, Apple Fred S, Scott Mitchell G, Wu Alan H B, Little Randie R, Fitzgerald Robert L
Department of Pathology, University of California, San Diego, Center for Advanced Laboratory Medicine, San Diego, CA, United States.
InSource Diagnostics, Monrovia, CA, United States.
Clin Biochem. 2018 Nov;61:18-22. doi: 10.1016/j.clinbiochem.2018.09.007. Epub 2018 Sep 17.
A multisite investigation compared the analytical performance of a point-of-care (POC) HbA1c device with multiple commonly used HbA1c laboratory methods and an NGSP (National Glycohemoglobin Standardization Program) reference method.
The Afinion AS100 POC device analyzed HbA1c using 618 EDTA whole blood excess patient specimens with clinically indicated HbA1c testing. Results were compared to measurements across five clinical laboratories and the NGSP reference method. Precision was evaluated over 8-10 consecutive days for low-, mid-, and high-range HbA1c specimens at all five sites.
Over a wide range of HbA1c values (4.0%-15% HbA1c), 97.1% of the POC results and 94.5% of routine laboratory results fell within the target value of ±6% of the NGSP reference method results. The POC HbA1c results at 6.5% exhibited a total relative bias of -0.6% (-0.04% HbA1c) compared to the reference method while the aggregate of laboratory methods displayed a relative bias of -0.9% (-0.06% HbA1c). The total imprecision of the POC results ranged from 0.74-2.13% CV across the analytic measurement range compared to 0.81-3.23% CV for the routine laboratory methods.
The accuracy and precision of the Afinion POC HbA1c method was comparable to the laboratory HbA1c methods supporting the FDA's recent approval of the Afinion HbA1c Dx device for use in the diagnosis of diabetes.
一项多中心研究比较了即时检测（POC）糖化血红蛋白（HbA1c）设备与多种常用的HbA1c实验室检测方法以及美国国家糖化血红蛋白标准化计划（NGSP）参考方法的分析性能。
Afinion AS100 POC设备使用618份用于临床HbA1c检测的乙二胺四乙酸（EDTA）抗凝全血过量患者样本分析HbA1c。将结果与五个临床实验室的检测结果以及NGSP参考方法进行比较。在所有五个研究地点，对低、中、高浓度范围的HbA1c样本连续8 - 10天评估精密度。
在较宽的HbA1c值范围（4.0% - 15% HbA1c）内，POC检测结果的97.1%以及常规实验室检测结果的94.5%落在NGSP参考方法结果±6%的目标值范围内。与参考方法相比，POC设备在HbA1c为6.5%时的总相对偏差为 - 0.6%（-0.04% HbA1c），而实验室检测方法的总相对偏差为 - 0.9%（-0.06% HbA1c）。在分析测量范围内，POC检测结果的总不精密度范围为0.74% - 2.13%变异系数（CV），而常规实验室检测方法为0.81% - 3.23% CV。
Afinion POC HbA1c方法的准确性和精密度与支持美国食品药品监督管理局（FDA）近期批准Afinion HbA1c诊断设备用于糖尿病诊断的实验室HbA1c方法相当。
