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目的 A1cNOW+~(TM)糖化血红蛋白(HbA_1c)测试卡是一种即时检测设备,本研究旨在评价其性能。方法使用A1cNOW+~(TM)测试卡测定237例门诊患者的HbA_1c水平,并与中心实验室的TOSOH G7仪器测定的HbA_1c结果进行相关分析;检测该仪器的精密度,并分析二甲双胍和维生素C对检测结果的影响。结果 A1cNOW+~(TM)测定值(Y)与TOSOH G7测定值(X)的回归方程为Y=0.9924X+0.0785(r=0.97,P<0.001)。误差分析显示,两者之间的检测误差介于0%～18.2%。精密度分析显示,同批号测试卡的批内变异系数(CV)为2.1%～5.0%,不同批号测试卡的批间CV为3.6%～3.9%。二甲双胍给药前后的测试卡结果与TOSOH G7的检测结果分别为7.5%±1.07%、7.4%±0.99%和7.7%±1.12%(P>0.05)。结论 A1cNOW+~(TM)快速HbA_1c测试卡具有良好的准确度、精密度和抗干扰能力,且操作简便、快捷,适合医院快速检测。
Aims The A1cNOW + ~ (HbA_1c) test card is a real-time testing device designed to evaluate its performance. Methods The HbA_1c level in 237 outpatients was determined by A1cNOW + ~ (TM) test card and correlated with the results of HbA_1c measured by TOSOH G7 in the central laboratory. The precision of the instrument was tested and the effects of metformin and vitamin C on the detection Effect of the result. Results The regression equation between the measured value of A1cNOW + ~ (TM) and the measured value of TOSOH G7 (X) was Y = 0.9924X + 0.0785 (r = 0.97, P <0.001). Error analysis shows that the detection error between the two is between 0% ~ 18.2%. The precision analysis showed that the intra-assay coefficient of variation (CV) for the same batch of test cards ranged from 2.1% to 5.0%, and the inter-lot CVs for different lot sizes tested cards ranged from 3.6% to 3.9%. Test results before and after metformin administration were 7.5% ± 1.07%, 7.4% ± 0.99% and 7.7% ± 1.12%, respectively, with TOSOH G7 (P> 0.05). Conclusion A1cNOW + ~ (TM) rapid HbA_1c test card has good accuracy, precision and anti-interference ability, and the operation is simple, fast and suitable for rapid detection in hospitals.