MP1干式分析仪和全自动生化分析仪检测同型半胱氨酸的方法比对

Comparison of Method of MP1 Dry Analyzer and Automatic Chemistry Analyzer in Testing the Homocysteine

目的对MP1干式分析仪与日立7100全自动生化分析仪检测同型半胱氨酸(HCY)结果进行比对分析及偏倚进行评估。方法参考美国国家临床实验室标准委员会(CLSI)EP9-A2文件规定,以大型生化分析仪的检测结果为比较方法(X),MP1干式分析仪及配套的试剂盘的检测结果为实验方法(Y),计算X和Y之间预期偏差的可信区间,以行业标准规定的15%的偏差要求为标准,并对其进行偏倚评估。结果 HCY在医学决定水平处的预期偏倚低于行业标准的允许误差范围,线性回归方程级相关性良好(r^2>0.95)。结论 MP1干式分析仪检测HCY临床可接受,可以保证检验结果的可靠性。

Objective To compare and analyze the MP1 dry analyzer and Hitachi 7100 automatic chemistry analyzer in testing the homocysteine and evaluate the bias. Methods The test results of large chemistry analyzer was used as X, and the test results of MP1 dry analyzer and matching reagent plate were used as Y, and the credibility interval of expected deviation between X and Y was calculated according to the（CLSI） EP9-A2, and the bias were evaluated according to the 15%bias requirement stipulated by the industrial standards. Results The expected bias of HCY in the medical decision level was lower than the error range allowed by the industrial standards, and the correlation of liner regression equation was good,（r^20.95）. Conclusion The MP1 dry analyzer in testing HCY can be received in clinic, which can ensure the reliability of test results.