Alarmingly poor performance in Chlamydia trachomatis point-of-care testing
Alarmingly poor performance in Chlamydia trachomatis point-of-care testing
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DOI：
10.1136/sti.2010.042598
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发表时间：
2010-10-01
影响因子：
3.6
通讯作者：
Hoebe, Christian J. P. A.
中科院分区：
文献类型：
--
作者：
van Dommelen, Laura;van Tiel, Frank H.;Hoebe, Christian J. P. A.
沙眼衣原体（CT）感染是世界范围内最常见的性传播感染（STI）。最常用的CT诊断试验是核酸扩增试验（NAAT），具有高度敏感性和特异性。为了进一步缩短诊断延迟时间，以防止CT传播，使用床旁（POC）测试可能是前进的方向。目的评估三种POC测试，Handilab-C，Biorapid Chlamydia Ag测试和QuickVue Chlamydia测试的诊断性能，并与NAAT进行比较。2007年9月至2008年4月期间在性病诊所就诊的患者被要求参加。女性被要求完成一份简短的问卷调查，并收集6个阴道拭子（SVS）。SVS 2用于NAAT，SVS 3至5随机用于不同的POC试验。SVS 1和6用于确定定量CT负荷，以验证连续SVS的使用。所有POC测试均在不了解NAAT结果的情况下进行。NAAT被用作“金标准”。CT患病率为11%，在我们的人口。Biorapid ChLAMYDIA Ag检测、QuickVue Chlamydia检测和Handilab-C检测的敏感性分别为17%、27%和12%.Conclusions评价的POC检测，由于其敏感性非常低，尚未准备好广泛使用。这些结果强调了对POC测试进行高质量保证的必要性，特别是考虑到这些测试在互联网上的可用性增加。
Background Infection by Chlamydia trachomatis (CT) is the most prevalent sexually transmitted infection (STI) world wide. The most frequently used diagnostic test for CT is a nucleic acid amplification test (NAAT), which is highly sensitive and specific. To further shorten time delay until diagnosis has been made, in order to prevent CT spread, the use of point-of-care (POC) tests may be the way forward.Objectives The diagnostic performance of three POC tests, Handilab-C, Biorapid CHLAMYDIA Ag test and QuickVue Chlamydia test, was evaluated and compared with NAAT.Methods All women, above the age of 16 years, attending for a consultation at an STI clinic between September 2007 and April 2008, were asked to participate. Women were asked to complete a short questionnaire and to collect six self-taken vaginal swabs (SVS). SVS 2 was used for NAAT and SVS 3 to 5 were randomised for the different POC tests. SVS 1 and 6 were used for determining quantitative CT load to validate the use of successive SVS. All POC tests were performed without knowledge of NAAT results. NAAT was used as the 'gold standard'.Results 772 women were included. CT prevalence was 11% in our population. Sensitivities of the Biorapid CHLAMYDIA Ag test, QuickVue Chlamydia and Handilab-C test were 17%, 27% and 12%, respectively.Conclusions The evaluated POC tests, owing to their very low sensitivities, are not ready for widespread use. These results underline the need for good-quality assurance of POC tests, especially in view of the increased availability of these tests on the internet.