Shipitsyna E, Zolotoverkhaya E, Agné-Stadling I, Krysanova A, Savicheva A, Sokolovsky E, Domeika M, Unemo M
Laboratory of Microbiology, D.O. Ott Research Institute of Obstetrics and Gynaecology, St. Petersburg, Russia.
J Eur Acad Dermatol Venereol. 2009 Mar;23(3):268-76. doi: 10.1111/j.1468-3083.2008.03038.x. Epub 2008 Dec 19.
In Russia, nationally developed nucleic acid amplification tests (NAATs), which have never been validated to international commercially available NAATs, are mainly used in the diagnosis of Chlamydia trachomatis infection.
To evaluate the performance characteristics of six NAATs widely used to diagnose C. trachomatis infection in Russia.
In total, 446 consecutive symptomatic patients (319 females and 127 males) were included. Five polymerase chain reaction (PCR) assays and one real-time nucleic acid sequence-based amplification (NASBA) assay were evaluated on cervical and vaginal samples from females and on urethral and first voided urine samples from males. As reference methods, the Cobas Amplicor PCR, as the main 'gold standard' method, and LightMix 480HT PCR were used.
The overall prevalence of C. trachomatis infection was 12.6%. The Russian NAATs and the reference methods displayed a high level of concordance (97.9% to 99.2%). In comparison with the reference methods, the sensitivities, specificities, positive predictive values and negative predictive values of the Russian tests in different specimens ranged from 86.1% to 100%, 99.1% to 100%, 92.3% to 100% and 98.2% to 100%, respectively.
According to the reference methods, C. trachomatis NAATs developed and used in Russia have relatively good performance characteristics for both invasive and non-invasive samples. However, larger studies that include symptomatic and asymptomatic patients as well as genital and extra-genital samples, and in comparison with other internationally well-recognized, validated, and ideally Food and Drug Administration-approved C. trachomatis NAATs performed strictly according to the manufacturer's instructions, need to be conducted.
在俄罗斯，主要使用国内研发的核酸扩增检测（NAATs）来诊断沙眼衣原体感染，这些检测从未按照国际上商用的NAATs进行过验证。
评估俄罗斯广泛用于诊断沙眼衣原体感染的六种NAATs的性能特征。
总共纳入了446例有症状的连续患者（319例女性和127例男性）。对女性的宫颈和阴道样本以及男性的尿道和首次晨尿样本进行了五种聚合酶链反应（PCR）检测和一种基于核酸序列的实时扩增（NASBA）检测。作为参考方法，使用了Cobas Amplicor PCR作为主要的“金标准”方法以及LightMix 480HT PCR。
沙眼衣原体感染的总体患病率为12.6%。俄罗斯的NAATs与参考方法显示出高度一致性（97.9%至99.2%）。与参考方法相比，俄罗斯检测在不同样本中的敏感性、特异性、阳性预测值和阴性预测值分别为86.1%至100%、99.1%至100%、92.3%至100%和98.2%至100%。
根据参考方法，俄罗斯研发和使用的沙眼衣原体NAATs对侵入性和非侵入性样本均具有相对良好的性能特征。然而，需要开展更大规模的研究，纳入有症状和无症状患者以及生殖器和生殖器外样本，并与其他国际公认、经过验证且理想情况下经美国食品药品监督管理局批准的沙眼衣原体NAATs严格按照制造商说明进行比较。
