Bristow Claire C, McGrath Mark R, Cohen Adam C, Anderson Laura J, Gordon Kristie K, Klausner Jeffrey D
From the *Division of Global Public Health, Department of Medicine, University of California San Diego, La Jolla, CA; †AIDS Healthcare Foundation, Los Angeles, CA; ‡UCLA Fielding School of Public Health, Los Angeles, CA; and §UCLA David Geffen School of Medicine, Los Angeles, CA.
Sex Transm Dis. 2017 Jul;44(7):398-400. doi: 10.1097/OLQ.0000000000000627.
Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are frequently asymptomatic, requiring highly accurate diagnostic tests and proper management to prevent further transmission. We compared two nucleic acid tests, Xpert® CT/NG (Cepheid, Sunnyvale, CA) point-of-care platform and at an offsite clinical laboratory with Aptima Combo 2® (Hologic, Inc., San Diego, CA) assay, for the detection of extragenital infection in patients at an STI clinic in Hollywood, CA.We calculated concordance between the two assays and used the exact binomial method to calculate 95% confidence intervals (CIs) for each specimen type and pathogen.The concordance between the two assays was 97.7% (95% CI: 95.7%,99.0%) for 393 paired CT rectal results, 98.2% (95% CI: 96.4%,99.3%) for 391 paired NG rectal results and 98.4% (95% CI: 96.8%,99.4%) for 448 paired NG pharyngeal results.The performance of Xpert® CT/NG assay in point-of-care testing in extragenital specimens was highly similar to the laboratory-based platform.
沙眼衣原体（CT）和淋病奈瑟菌（NG）感染通常没有症状，需要高度准确的诊断测试和适当的管理以防止进一步传播。我们比较了两种核酸检测方法，即Xpert® CT/NG（Cepheid公司，加利福尼亚州桑尼维尔）即时检测平台以及在加利福尼亚州好莱坞一家性传播感染诊所的场外临床实验室使用Aptima Combo 2®（Hologic公司，加利福尼亚州圣地亚哥）检测法，以检测患者的生殖器外感染。我们计算了两种检测方法之间的一致性，并使用精确二项式方法计算每种样本类型和病原体的95%置信区间（CI）。对于393对CT直肠检测结果，两种检测方法之间的一致性为97.7%（95% CI：95.7%，99.0%）；对于391对NG直肠检测结果，一致性为98.2%（95% CI：96.4%，99.3%）；对于448对NG咽拭子检测结果，一致性为98.4%（95% CI：96.8%，99.4%）。Xpert® CT/NG检测法在生殖器外样本即时检测中的表现与基于实验室的平台高度相似。
