Hobbs Marcia M, van der Pol Barbara, Totten Patricia, Gaydos Charlotte A, Wald Anna, Warren Terri, Winer Rachel L, Cook Robert L, Deal Carolyn D, Rogers M Elizabeth, Schachter Julius, Holmes King K, Martin David H
Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA.
Sex Transm Dis. 2008 Jan;35(1):8-13. doi: 10.1097/OLQ.0b013e31815d968d.
On June 27, 2006, the NIH conducted a workshop to review published data and current field practices supporting the use of self-obtained vaginal swabs (SOVs) as specimens for diagnosis of sexually transmitted infections (STIs). The workshop also explored the design of studies that could support FDA clearance of SOVs for STI testing, particularly for specimens collected in nonclinical settings including patients' homes. This report summarizes the workshop findings and recommendations. Participants concluded that self-obtained vaginal swabs are well accepted by women of all ages and that SOVs perform as well as or better than other specimen types for Chlamydia trachomatis and Neisseria gonorrhoeae detection using transcription-mediated amplification. In addition, workshop participants recommended the validation of SOV testing by public health practitioners and manufacturers of STI diagnostic tests to expedite incorporation of SOVs as a diagnostic option in clinical and nonclinical settings for Chlamydia trachomatis and Neisseria gonorrhoeae testing. Similarly, SOVs should be explored for use in the diagnosis of other sexually transmitted pathogens.
2006年6月27日,美国国立卫生研究院举办了一次研讨会,以审查已发表的数据和当前的行业实践,这些数据和实践支持使用自行采集的阴道拭子(SOV)作为诊断性传播感染(STI)的标本。该研讨会还探讨了能够支持美国食品药品监督管理局批准将SOV用于性传播感染检测的研究设计,特别是针对在非临床环境(包括患者家中)采集的标本。本报告总结了研讨会的结果和建议。参与者得出结论,自行采集的阴道拭子受到各年龄段女性的广泛接受,并且在使用转录介导扩增法检测沙眼衣原体和淋病奈瑟菌时,SOV的表现与其他标本类型相当或更好。此外,研讨会参与者建议公共卫生从业者和性传播感染诊断测试制造商对SOV检测进行验证,以加快将SOV作为沙眼衣原体和淋病奈瑟菌检测的诊断选项纳入临床和非临床环境。同样,应探索将SOV用于诊断其他性传播病原体。