可比性验证与线性评价方法在生化分析仪确认中的应用初探

Comparability verification and linearity evaluation in the performance evaluation of biochemical analyzers

目的探索可比性验证与线性评价方法在血站新购进的生化分析仪性能确认中的应用。方法按EP15-A2和WS/T 407-2012要求,运用进行线性评价、可比性验证方法对新购4040＋生化分析仪检测丙氨酸氨基转移酶（ALT）进行确认。结果精密度CV值和比对偏差均小于6%,与说明书一致,可以接受;测定项目预期值与测定值相相关性良好（回归系数为1. 000 232）,在可接受范围内,检测结果呈一阶线性;与检验科性能和准确度已证实且长期参加室间质评成绩优秀的检测系统比对,相关系数r2为0. 998,结果偏倚在CLIA,88规定的范围内。结论可比性验证与线性评价方法对血站新购进的生化分析仪进行性能确认是切实可行的、有效的。

Objective To assess application of comparability verification and linearity evaluation in evaluating newly acquired clinical chemistry analyzers. Methods According to EP15-A2 and WS/T 407-2012,ALT was measured by 4040＋analyzer with factory reagents. The comparability verification and linearity evaluation were used for performance evaluation.Results As for precision,the CV values and standard deviation were both less than 6%; The theoretically predicted values are in good consistency with the actual data（ regression coefficient is 1. 000 232）; The bias is acceptable（ within the prescribed scope of CLIA,88） with the Roche COBAS-6000 analyzer,compared with the external quality assessment of the ministry of health clinical inspection center. Conclusion Comparability verification and linearity evaluation are feasible and effective to evaluate the performance of the newly purchased biochemical analyzer at the blood station.