【摘要】 目的 分析2021年上海市同型半胱氨酸（Hcy）项目正确度验证计划反馈数据，了解上海市临床实验室Hcy检测质量。方法 收集临床实验室剩余血清样本，制备成高、低2个浓度水平的混合血清室间质量评价调查品（HCY2021-A、HCY2021-B），发放至上海市临床检验中心室间质量评价参评实验室。实验室在3个连续工作日内对调查品进行多次测定，通过室间质量评价平台上报结果。用参考测量程序进行赋值，分析临床实验室检测值与靶值的偏移、实验室内变异系数（CV）和按不同试剂分组后的偏移、实验室内CV。结果HCY2021-A、HCY2021-B测定结果实验室内CV分别为0.28%～9.44%、0.25%～10.69%，与靶值的偏移分别为-20.21%～31.39%、-29.66%～23.93%。按试剂进行分组，HCY2021-A、HCY2021-B测定均值与靶值的偏移分别为-25.33%～20.27%、-18.41%～23.00%。以参考测量程序定值结果为靶值，以1/2允许总误差（TEa）为评价标准，参评临床实验室高、低2个浓度水平调查品的合格率分别为62.07%和65.52%。结论 上海市临床实验室Hcy检测正确度水平有待改进。更多还原

【Abstract】 Objective To evaluate the analytical quality of homocysteine(Hcy) in Shanghai clinical laboratories,through analyzing the results of Hcy trueness verification of 2021,Shanghai. Methods Residual samples from clinical laboratory tests were collected and prepared into high and low concentrations of frozen mixed serum samples(HCY2021-A and HCY2021-B). Participating clinical laboratories measured the samples for several times in 3 consecutive working days and reported the results through the network platform. The deviation between clinical laboratory test data and target value,coefficient of variation(CV),deviation and CV after grouping by different reagents were analyzed. Results The CV of HCY2021-A and HCY2021-B were 0.28%-9.44% and 0.25%-10.69%,respectively. The deviations between HCY2021-A and target value were-20.21%-31.39%. The deviations between HCY2021-B and target value were-29.66%-23.93%. Grouped by reagents,the deviations between the mean value of HCY2021-A and target value were-25.33%-20.27%,and the deviations between the mean value of HCY2021-B and target value were-18.41%-23.00%. The qualified rates of clinical laboratories with the results of reference method as the target value and the standard of 1/2 allowable total error(TEa) were 62.07% and 65.52%,respectively. Conclusions The accuracy of Hcy determination in Shanghai clinical laboratories remains to be improved.更多还原