微粒子化学发光分析仪检测TESTO的性能验证

Performance verification of TESTO by particles chemiluminescence detection

目的：验证贝克曼ACCESS2微粒子化学发光仪检测睾酮（TESTO）的性能,同时探讨适用于贝克曼ACCESS2微粒子化学发光分析系统性能的验证方案。方法：以TESTO检测为例,参考美国临床实验室标准化委员会（National Committee for Clinical Laboratory,NCCLS）文件,制定一套实验方法验证方案,对方法的精密度、正确度、分析测量范围、生物参考区间、携带污染率进行验证。结果：重复性精密度高低水平各为5.06%和2.13%,中间精密度高低水平各为7.59%和6.75%;正确度的偏倚为2.94%~8.80%;分析测量范围为0.22~10.4 ng/ml;参考范围为男性2.19~7.52 ng/ml,女性0.08~0.59 ng/ml;携带污染率为0.42%。结论：贝克曼ACCESS2微粒子化学发光分析仪精密度好、正确度高、分析测量范围广、厂家提供的参考区间可转移至临床实验室使用、携带污染率低;各项验证指标均符合厂家提供的要求,验证全部通过,且验证方案简便、有效。

Objective To verify the performances of Beckman ACCESS2 particles chemiluminescence detector in detection of testosterone（TESTO）, and to explore the verification scheme for the system performances of Beckman ACCESS2 particles chemiluminescence detector. Methods A set of laboratory verification scheme was proposed with TESTO detection as an example and with references to the specifications of National Committee for Clinical Laboratory（NCCLS）, which detected the precision,accurateness, measuring range, biological reference interval and residual contamination rate. Results The high and low values for repeatability precision were 5.06% and 2.13% respectively, and those for intermediate precision were 7.59% and 6.75%respectively. The bias of the accurateness was from 2.94% to 8.80%, the measuring range was between 0.22 and 10.4 ng/ml, the biological reference interval was from 2.19 to 7.52 ng/ml for the male and from 0.08 to 0.59 ng/ml for the female, and the residual contamination ratio was 0.42%. Conclusion Beckman ACCESS2 particles chemiluminescence detector behaves well in the precision, accurateness, measuring range, biological reference interval and residual contamination rate, and the verification scheme is simple and effective.