Accuracy and Precision of a Point-of-Care HbA1c Test
Accuracy and Precision of a Point-of-Care HbA1c Test
复制标题
DOI：
10.1177/1932296819831292
复制
发表时间：
2020-09-01
影响因子：
5
通讯作者：
San George, Richard C.
中科院分区：
文献类型：
--
作者：
Arnold, William D.;Kupfer, Kenneth;San George, Richard C.
背景资料：床旁（POC）血红蛋白A1 c（HbA 1c）测试比实验室测试有优势，但这些方法的准确性和精密度仍存在一些问题。POC Afinion（TM）HbA 1c Dx检测的准确度和精密度进行了调查。方法：从三个临床研究中心的前瞻性入组受试者中收集了涵盖检测范围的样本。通过与NGSP二级参考实验室（SRL）获得的值的相关性和偏倚，估计使用手指针刺和静脉全血样本进行POC检测的准确性。通过计算变异系数（CV）和标准差（SD），根据一式两份结果估计使用手指针刺样本的POC试验的精密度，并使用方差分析（ANOVA）将其分为其分量。使用静脉血对三个测试卡片批次中的每一个批次重复运行四次的样本进行POC检测的精密度评价，每天两次，连续10天。SD和CV的研究中心和整体counted.Results：在整个检测范围内，POC测试结果从手指针刺和静脉全血样本高度相关的结果从NGSP SRL（r = 0.99）。使用手指针刺样本的平均偏倚为-0.021% HbA 1c（相对-0.346%），使用静脉样本的平均偏倚为-0.005% HbA 1c（相对-0.093%）。不精密度范围为0.62%至1.93%CV手指针刺样品和1.11%至1.69%CV静脉samples.Conclusions：结果表明，POC测试评价这里是准确和精确的手指针刺和静脉全血。
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 (TM) 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 (r = .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.