Aptima NAAT Assays Outperform Clinician Diagnosis for Bacterial Vaginosis, Candidiasis, and Trichomoniasis
A prospective multicenter study validated two new TMA-based nucleic acid amplification tests for vaginitis diagnosis across nearly 3,000 patient- and clinician-collected vaginal swabs. The Aptima BV and Candida/Trichomonas assays achieved sensitivities of 84.7-96.5% and specificities of 89.6-99.1% across all targets, consistently outperforming both clinician diagnoses and traditional in-clinic assessments when compared to gold-standard reference methods.
The original study
Clinical Validation of the Aptima Bacterial Vaginosis and Aptima
- Authors
- Schwebke JR, Taylor SN, Ackerman R, Schlaberg R, Quigley NB, Gaydos CA, et al.
- Journal
- Journal of clinical microbiology
- Type
- Clinical Study, Comparative Study, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Validation Study
- PMID
- 31748322
Original abstract
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, VVC, 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 VVC, 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 VVC due to the Candida species group, 4% for VVC 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, in-clinic 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.