Navas Maria E, Musoke Lewis, Van Epps Puja, Allen Kristen, Coffey K C, Appleby-Sigler Andrea, Peralta Karla, Del Pilar Mark, DuBois Marie, Kapadia Iqbal, Tash Kaley, Vallone John, Barrera Aurelio, Adams Jill, Rajagopalan Chitra, Rexroth Karen, Benator Debra, Melton Shelby D, Wachsmann Megan B, Wais Jennifer, Catania Jelena, Ho Minh Q, Benitez Espinosa Ruben, Wigton Bradley, Kaka Anjum S, Niehans Gloria, Wang-Rodriguez Jessica, Klutts J Stacey
VA Northeast Ohio Health Care System, Cleveland, OH, US.
Case Western Reserve University School of Medicine, Cleveland, OH, US.
Am J Clin Pathol. 2025 Mar 8;163(3):406-410. doi: 10.1093/ajcp/aqae135.
Rectal and pharyngeal infections with gonorrhea and chlamydia are of concern because they are associated with higher risk of HIV acquisition. Extragenital screening in asymptomatic persons at high risk may have the potential to reduce the incidence of these sexually transmitted infections (STIs). Several testing platforms are available for the testing of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using nucleic acid amplification tests (NAATs). Self-collected extragenital samples are currently not approved by the US Food and Drug Administration in any NAAT platform. This study compares the analytical performance of self-collected extragenital specimens to that of clinician-collected specimens.
We performed a multicenter/multiplatform validation study as a National Veterans Health Administration Pathology and Laboratory Medicine quality improvement project, with 9 different participating sites. Self-collected specimens were obtained at the same time as clinician-collected specimens. Clinician-collected specimens were used as the gold standard to evaluate the sensitivity and specificity of self-collection.
A total of 2324 individual tests were analyzed (501 rectal and 661 oropharyngeal). The sensitivity was 94.44% for CT and 100% for NG for rectal specimens, whereas it was 100% for CT and 97.22% for NG for oral specimens. Specificity for oral specimens was 99.85% for CT and 99.36% for NG, whereas for rectal specimens, it was 99% for CT and NG.
Self-collected specimens for extragenital CT/NG testing are highly sensitive and specific, with negative predictive values of 100%. Self-collection has the potential to overcome a major barrier for STI screening by providing an accessible, convenient, and patient-centered alternative.
直肠和咽部的淋病及衣原体感染令人担忧，因为它们与感染艾滋病毒的较高风险相关。对高危无症状人群进行生殖器外筛查可能有降低这些性传播感染（STIs）发病率的潜力。有几种检测平台可用于通过核酸扩增试验（NAATs）检测沙眼衣原体（CT）和淋病奈瑟菌（NG）。目前美国食品药品监督管理局未批准在任何NAAT平台上使用自行采集的生殖器外样本。本研究比较了自行采集的生殖器外标本与临床医生采集的标本的分析性能。
作为美国退伍军人健康管理局病理学和实验室医学质量改进项目，我们开展了一项多中心/多平台验证研究，有9个不同的参与站点。自行采集的标本与临床医生采集的标本同时获取。以临床医生采集的标本作为金标准来评估自行采集的敏感性和特异性。
共分析了2324项个体检测（501项直肠检测和661项口咽检测）。直肠标本中CT的敏感性为94.44%，NG为100%；而口咽标本中CT为100%，NG为97.22%。口咽标本中CT的特异性为99.85%，NG为99.36%；直肠标本中CT和NG均为99%。
用于生殖器外CT/NG检测的自行采集标本具有高度敏感性和特异性，阴性预测值为100%。自行采集有可能通过提供一种可及、便捷且以患者为中心的替代方式，克服性传播感染筛查的一个主要障碍。
