Verkooyen Roel P, Noordhoek Gerda T, Klapper Paul E, Reid Jim, Schirm Jurjen, Cleator Graham M, Ieven Margareta, Hoddevik Gunnar
Department of Medical Microbiology and Infectious Diseases, Erasmus MC, Rotterdam, The Netherlands and University of Manchester, United Kingdom.
J Clin Microbiol. 2003 Jul;41(7):3013-6. doi: 10.1128/JCM.41.7.3013-3016.2003.
The first European Quality Control Concerted Action study was organized to assess the ability of laboratories to detect Chlamydia trachomatis in a panel of urine samples by nucleic acid amplification tests (NATs). The panel consisted of lyophilized urine samples, including three negative, two strongly positive, and five weakly positive samples. Ninety-six laboratories in 22 countries participated with a total of 102 data sets. Of 204 strongly positive samples 199 (97.5%) were correctly reported, and of 506 weakly positive samples 466 (92.1%) were correctly reported. In 74 (72.5%) data sets correct results were reported on all samples, and 17 data sets (16.7%) showed either one false-negative or one false-positive result. In another 11 data sets, two or more incorrect results were reported, and two data sets reported a false-positive result on one negative sample. The Roche COBAS Amplicor test was performed in 44 (43%) data sets, the Abbott LCx assay was performed in 31 (30%) data sets, the Roche Amplicor manual assay was performed in 9 (9%) data sets, an in-house PCR was performed in 9 (9%) data sets, the Becton Dickinson ProbeTec ET assay was performed in 5 (4.9%) data sets, and the GenProbe TMA assay was performed in 4 (3.9%) data sets. The results of the Roche Amplicor manual (95.6% correct), COBAS Amplicor (97.0%), and Abbott LCx (94.8%) tests were comparable (P = 0.48). The results with the in-house PCR, BD ProbeTec ET, and GenProbe TMA tests were reported correctly in 88.6, 98, and 92.5% of the tests, respectively. Freeze-drying of clinical urine specimens proved to be a successful method for generating standardized, stable, and easy-to-transport samples for the detection of C. trachomatis by using NATs. Although the results, especially the specificity, for this proficiency panel were better than most quality control studies, sensitivity problems occurred frequently, underlining the need for good laboratory practice and reference reagents to monitor the performance of these assays.
首个欧洲质量控制联合行动研究旨在评估实验室通过核酸扩增检测（NAT）在一组尿液样本中检测沙眼衣原体的能力。该样本组由冻干尿液样本组成，包括3份阴性样本、2份强阳性样本和5份弱阳性样本。22个国家的96家实验室参与其中，共提供了102个数据集。在204份强阳性样本中，199份（97.5%）被正确报告；在506份弱阳性样本中，466份（92.1%）被正确报告。在74个（72.5%）数据集中，所有样本的结果均被正确报告，17个数据集（16.7%）出现了1例假阴性或1例假阳性结果。在另外11个数据集中，报告了两个或更多错误结果，有两个数据集在1份阴性样本上报告了假阳性结果。44个（43%）数据集采用了罗氏COBAS Amplicor检测，31个（30%）数据集采用了雅培LCx检测，9个（9%）数据集采用了罗氏Amplicor手工检测，9个（9%）数据集采用了内部PCR检测，5个（4.9%）数据集采用了贝克曼库尔特ProbeTec ET检测，4个（3.9%）数据集采用了GenProbe TMA检测。罗氏Amplicor手工检测（95.6%正确）、COBAS Amplicor检测（97.0%）和雅培LCx检测（94.8%）的结果具有可比性（P = 0.48）。内部PCR检测、BD ProbeTec ET检测和GenProbe TMA检测的结果分别在88.6%、98%和92.5%的检测中被正确报告。临床尿液标本的冻干被证明是一种成功的方法，可生成标准化、稳定且易于运输的样本，用于通过NAT检测沙眼衣原体。尽管该能力验证样本组的结果，尤其是特异性，优于大多数质量控制研究，但敏感性问题仍频繁出现，这突出表明需要良好的实验室规范和参考试剂来监测这些检测方法的性能。
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