Bootman J S, Kitchin P A
PCR Reference Centre, AIDS Collaborating Centre, NIBSC, Potters Bar, Herts, UK.
J Virol Methods. 1994 Aug;49(1):1-8. doi: 10.1016/0166-0934(94)90050-7.
Following the recent developments in diagnostic polymerase chain reaction (PCR) technology, we have assessed a set of HIV-1 DNA reference standards using the first commercial diagnostic test kit for the detection of HIV-1 (Amplicor, Roche) in an international collaborative study. Nineteen laboratories in 11 countries analysed a set of ten (re-coded) HIV-1 DNA reference standards, whose performance had been validated in a previous collaborative study (Bootman and Kitchin, 1992). Results from the current study show that, using the diagnostic kit, 84% of laboratories (16/19) obtained correct diagnoses for all ten test samples. One additional laboratory failed only to detect the sample containing ten copies of target template. Test results from the remaining two laboratories were declared void in accordance with the Amplicor quality control guidelines.
随着诊断性聚合酶链反应（PCR）技术的最新发展，我们在一项国际合作研究中，使用首个用于检测HIV-1的商业诊断试剂盒（Amplicor，罗氏公司）对一组HIV-1 DNA参考标准品进行了评估。来自11个国家的19个实验室分析了一组十个（重新编码的）HIV-1 DNA参考标准品，其性能在之前的一项合作研究中已得到验证（Bootman和Kitchin，1992年）。当前研究结果表明，使用该诊断试剂盒时，84%的实验室（16/19）对所有十个测试样本都做出了正确诊断。另有一个实验室仅未能检测出含有十个拷贝目标模板的样本。根据Amplicor质量控制指南，其余两个实验室的测试结果被宣布无效。
