自建新检测系统ALT测定的精密度和正确度评价

The evaluation on ALT determination precision and accuracy of new self-built system

目的通过对自建新检测系统与参考系统ALT测定进行精密度和正确度评价,探讨自建新检测系统ALT测定结果的随机误差和系统误差,是否达到临床可接受标准。方法参照CLSI的EP5-A2和EP9-A2文件,以德灵全自动生化分析仪检测系统作为参考系统,自建新检测系统作为待评系统,分别用质控品和新鲜标本进行精密度评价和正确度评价。结果精密度评价:自建新检测系统天间不精密度和批内不精密度分别小于1/3和1/4允许误差;正确度评价:两个检测系统相关性良好,系统误差在临床允许误差范围内。结论自建新检测系统的误差达到临床可接受标准,检测结果具有可比性。

Objective To probe whether the random and systematic error of the result of ALT determination by new self- established system can reach the clinically acceptable standards,through the precision and accuracy evaluation on ALT determination by new self-established system and reference system. Methods Reference to EP5-A2 and EP9-A2 files of CLSI,we make Dimension RxL clinical chemistry systems as the reference system,and new self-established determination system as the evaluating one to evaluate the precision and accuracy with the controls and fresh specimens. Results The precision evaluation： for the new self-established determination system,the inter-day and intra imprecision are less than 1/3 and 1/4 of the allowable error respectively; the accuracy evaluation： the correlation of two detection systems is really good and the systematic error is in clinically-allowable range. Conclusion The systematic error of new self-established system reaches the clinically-acceptable standard which the test result is comparable.