Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae:: Results from a multicenter evaluation of the APTIMA assays for both infections

Vaginal swabs are the specimens of choice when screening for Chlamydia trachomatis and Neisseria gonorrhoeae:: Results from a multicenter evaluation of the APTIMA assays for both infections
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DOI:
10.1097/01.olq.0000190092.59482.96
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发表时间:
2005-12-01
影响因子:
3.1
通讯作者:
Hook, EW
Hook, EW
中科院分区:
医学4区
文献类型:
--
作者:
Schachter, J;Chernesky, MA;Hook, EW

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背景:阴道拭子最近被美国食品和药物管理局批准用于检测沙眼衣原体(CT)和淋病奈瑟菌(GC),使用Gen-Probe Incorporated的APTIMA COMBO2测定(AC2)。我们使用患者和临床收集的阴道拭子评估了APTIMA CT Assay (ACT) (CT), APTIMA GC Assay (AGC) (GC)和AC2(两种生物体)。方法:在计划生育、妇产科或性传播疾病门诊就诊的妇女进行首次采集尿液(fcu)、患者阴道拭子、医生阴道拭子和宫颈拭子的ACT、AGC和AC2检测。使用BD ProbeTec (Becton Dickinson)进行CT和GC检测第二次宫颈拭子和FCU。我们计算了阴道拭子检测CT和GC的敏感性和特异性。结果:1464名受试者中,180人有CT, 78人有GC。ACT对患者阴道拭子的敏感性和特异性分别为98.3%和96.5%;临床采集的阴道拭子,分别为97.2%和95.2%。患者阴道拭子的AGC敏感性和特异性分别为96.1%和99.3%;临床采集的阴道拭子,分别为96.2%和99.3%。AC2结果相似。如果FCU的CT或GC检测呈阳性,则约有94%的匹配阴道拭子呈阳性。阳性宫颈内膜拭子显示的一致性稍低(>为90%,>为88%)。使用阴道拭子发现的感染患者多于fcu。在AC2中,使用fcu鉴定出171例ct感染患者,使用收集的患者阴道拭子鉴定出196例。这种差异在CT上比在GC上更为明显。结论:阴道拭子标本在APTIMA检测中允许CT和GC的敏感和特异性检测。阴道拭子检出的感染病例与宫颈拭子检出的感染病例一样多,比fcu多,很可能是筛查的首选标本。
Background: Vaginal swabs were recently U.S. Food and Drug Administration-cleared for detecting Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) using Gen-Probe Incorporated's APTIMA COMBO2 Assay (AC2). We assessed the APTIMA CT Assay (ACT) for CT, APTIMA GC Assay (AGC) for GC, and AC2 for both organisms using patient- and clinician-collected vaginal swabs.Method: Women attending family planning, obstetrics and gynecology, or sexually transmitted disease (STD) clinics had first-catch urines (FCUs), patient-collected vaginal swabs, clinician-collected vaginal swabs, and endocervical swabs tested by ACT, AGC, and AC2. A second endocervical swab and FCU were tested using BD ProbeTec (Becton Dickinson) for CT and GC. We calculated sensitivity and specificity using vaginal swabs to detect CT and GC.Results: Of 1464 subjects enrolled, 180 had CT and 78 GC. ACT sensitivities and specificities for patient-collected vaginal swabs were 98.3% and 96.5%, respectively; for clinician -collected vaginal swabs, 97.2% and 95.2%, respectively. AGC sensitivities and specificities for patient-collected vaginal swabs were 96.1% and 99.3%, respectively; for clinician-collected vaginal swabs, 96.2% and 99.3%, respectively. AC2 results were similar. If an FCU tested positive for CT or GC, > 94% of matching vaginal swabs were positive. Positive endocervical swabs showed slightly less concordance (> 90% and > 88%, respectively). More infected patients were identified using vaginal swabs than FCUs. With AC2, 171 CT-infected patients were identified using FCUs and 196 using patient-collected vaginal swabs. This difference was more pronounced for CT than for GC.Conclusions: Vaginal swab specimens allowed sensitive and specific detection of CT and GC in the APTIMA assays. Vaginal swabs identified as many infected patients as endocervical swabs and more than FCUs, and may well he the specimen of choice for screening.