五种即时检验血糖仪的主要分析性能评价

目的评价5种即时检验（POCT）血糖仪的主要分析性能。方法选取高、中、低3份不同葡萄糖浓度的新鲜肝素抗凝全血以及2份不同浓度的血糖仪质控液，在5种不同型号POCT血糖仪组成的检测系统（分别为检测系统1-5）上各测定20次，进行精密度评价；同时5d内选取20份新鲜肝素抗凝全血在5个检测系统上测定，检测结果与目标检测系统（德国罗氏Modular PPI全自动生化分析仪及其配套试剂、校准品、质控品）的血浆测定值进行相关的统计学分析来评价准确度；再对各检测系统进行方法学评价。结果各检测系统批内及日间精密度均小于美国临床实验室标准化委员会（NCCLS）关于葡萄糖POCT允许范围的1／2，以检测系统3精密度最佳；各检测系统与目标检测系统相关系数（r）均〉0．975，与目标检测系统相对偏差均在允许范围之内，检测系统1相对偏差最小。结论5个检测系统精密度和准确度等方面均符合临床要求。

Analytic performance evaluation of five kinds of point-of -care testing blood glucose meters

Objective To evaluate the analytic performance of five kinds of blood glucose meters. Methods Three fresh whole blood samples of different levels of glucose and two levels of glucose quality controls were determined by five different kinds of point-of-care testing （POCT） blood glucose meters and the precision was evaluated. Twenty fresh whole blood samples were detected by five detection systems in five days. The results were analysed the correlation with target system（Roche Modular PPI automatic biochemical analyser and relevant reagent, calibrator and quality controis） in order to evaluate their accuracy. The technology of five detection systems were evaluted. Results The precision and accuracy of all detection systems were less than half of permit range about glucose POCT established by National Committee for Clinical Laboratory Standards （NCCLS） , especially the detection system 3. The correlation coefficients between the evaluated detection system and the target detection system were all more than 0. 975. The relative bias of the detection system 1 was the least. Conclusions The precision and accuracy of five detection systems were accorded with clinical requirements.