期刊
JOURNAL OF CLINICAL MICROBIOLOGY
卷 58, 期 2, 页码 -出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/JCM.01643-19
关键词
bacterial vaginosis; candidiasis; trichomoniasis; Nugent score; Amsel criteria; molecular test; diagnostic accuracy; sensitivity; specificity; clinician's diagnosis; Aptima
类别
资金
- Hologic
- Becton
- Dickinson
- Talis
- Abbott
- Binx
- Hologic, Inc.
- Roche
- Cepheid
- Roche Diagnostics
- Epoch Biosciences
- Curatek Pharmaceuticals
- Mycovia Pharmaceuticals
- Scynexis, Inc.
- NIBIB, NIH [U54 EB007958]
- NIAID, NIH [U-01068613]
Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, WC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for WC, and a composite of NAAT and culture for T. vaginalis. The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for WC due to the Candida species group, 4% for WC due to Candida glabrata, and 10% for T. vaginalis. Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis. Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, inclinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.
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