即时 HbA1c 检测的准确性和精密度。
Accuracy and Precision of a Point-of-Care HbA1c Test.
机构信息
Abbott Rapid Diagnostics, a division of Abbott Laboratories, San Diego, CA, USA.
Diabetes Diagnostic Laboratory, University of Missouri School of Medicine, Columbia, MO, USA.
出版信息
J Diabetes Sci Technol. 2020 Sep;14(5):883-889. doi: 10.1177/1932296819831292. Epub 2019 Mar 10.
BACKGROUND
Point-of-care (POC) hemoglobin A1c (HbA1c) testing has advantages over laboratory testing, but some questions have remained regarding the accuracy and precision of these methods. The accuracy and the precision of the POC Afinion™ HbA1c Dx test were investigated.
METHODS
Samples spanning the assay range were collected from prospectively enrolled subjects at three clinical sites. The accuracy of the POC test using fingerstick and venous whole blood samples was estimated via correlation and bias with respect to values obtained by an NGSP secondary reference laboratory (SRL). The precision of the POC test using fingerstick samples was estimated from duplicate results by calculating the coefficient of variation (CV) and standard deviation (SD), and separated into its components using analysis of variance (ANOVA). The precision of the POC test using venous blood was evaluated from samples run in four replicates on each of three test cartridge lots, twice per day for 10 consecutive days. The SD and CV by study site and overall were calculated.
RESULTS
Across the assay range, POC test results from fingerstick and venous whole blood samples were highly correlated with results from the NGSP SRL ( = .99). The mean bias was -0.021% HbA1c (-0.346% relative) using fingerstick samples and -0.005% HbA1c (-0.093% relative) using venous samples. Imprecision ranged from 0.62% to 1.93% CV for fingerstick samples and 1.11% to 1.69% CV for venous samples.
CONCLUSIONS
The results indicate that the POC test evaluated here is accurate and precise using both fingerstick and venous whole blood.
背景
即时检测（POC）血红蛋白 A1c（HbA1c）检测比实验室检测具有优势，但这些方法的准确性和精密度仍存在一些问题。本研究旨在考察 POC Afinion™ HbA1c Dx 检测的准确性和精密度。
方法
在三个临床中心前瞻性纳入研究对象采集涵盖检测范围的样本。采用末梢血和静脉全血样本，通过与 NGSP 二级参考实验室（SRL）获得的结果进行相关性和偏倚评估，评估 POC 检测的准确性。采用末梢血样本，通过计算变异系数（CV）和标准差（SD），并使用方差分析（ANOVA）将其分为组成部分，评估 POC 检测的精密度。对静脉血样本，每天在三个检测盒批次上重复运行 4 次，连续 10 天，每天两次，评估 POC 检测的精密度。计算各研究点和总体的 SD 和 CV。
结果
在整个检测范围内，末梢血和静脉全血样本的 POC 检测结果与 NGSP SRL 结果高度相关（r =.99）。使用末梢血样本的平均偏倚为-0.021%HbA1c（-0.346%相对），使用静脉血样本的平均偏倚为-0.005%HbA1c（-0.093%相对）。末梢血样本的不精密度范围为 0.62%至 1.93%CV，静脉血样本的不精密度范围为 1.11%至 1.69%CV。
结论
结果表明，本研究评估的 POC 检测使用末梢血和静脉全血均具有准确性和精密度。
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