根据NCCLS-EP9-A2方案对两种仪器检测血清铁蛋白的可比性分析

目的通过对血清铁蛋白(serum ferritin,SF)在不同检测系统上的测定,进行方法比对和偏倚评估来研究SF的检测结果在不同系统间的可比性,为实验室间的结果互认和正确度认可提供依据,并且探讨结果的临床可接受性。方法参考(美国)国家临床实验室标准委员会(NCCLS)的EP9-A2文件,把东曹全自动发光分析仪列为检测系统1,当作比较方法(X),检测系统2是贝克曼的AU 5400全自动生化分析仪,为实验方法(Y),用患者新鲜血清测定铁蛋白,计算(X)和(Y)之间预期偏倚的可信区间,以国家卫生计生委临床检验中心(NCCL)规定允许误差范围定为25%作标准,来判断不同检测系统的测定结果在医学决定水平处的可比性。结果该实验中SF测定结果的预期偏倚均在允许误差范围内,线性回归方程的相关性良好(R20.95),结果具有可比性,精密度良好,结果稳定。结论当质控在控并按操作规程进行校准时,两种分析系统测定血清铁蛋白的结果基本一致,AU 5400系统偏倚可接受,基本能得到具有一致临床意义的检测结果,本实验室的这两种检测系统的检测结果具有较好的可比性。

Comparability Analysis of Serum Ferritin Detection by Two Instruments according to NCCLS-EP9-A2 Protocol

Objective To investigate the comparability of different detection systems by detecting serum ferritin (SF) via two different instruments in order to facilitate mutual recognition of results between different laboratories and the research on the results of clinical acceptability.Methods We consulted the EP9-A2 document by the United States Clinical Laboratory Standards Committee (NCCLS)before we chose TOSOH AIA-2000ST as detection system A,which served as a comparative method (X)in this study.Detection system B was the Beckman AU5400 automatic biochemical analyzer,which served as an experimental method (Y) in this study.The confidence interval for the expected bias was calculated between (X) and (Y).The allowable error range of NCCL was 25％,which was used as a standard.The comparability of measured results from different detection systems was determined at the medical decision level.Results The expected bias of the SF measurement results was within the allowable error range,and the linear regression equations were well correlated (r2 ＞ 0.95),so the results were comparable.Conclusion When quality control is effective and operation proceeds in line with the protocol,similar results can be obtained from both instruments.The results of the two laboratory systems are comparable.