Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Vaginitis Assays: Results from a Prospective Multicenter Clinical Study.

Clicks: 386
ID: 106733
2020
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This article has not been analysed, so there is no overall score — reader engagement is measured and shown alongside.
AI Quality Assessment
Not analyzed
Readership in this journal
Emerging

Ranked #31 of 85 articles by views in Journal of clinical microbiology

Most read Least read

Bar heights use a square-root scale.

Mint this article as an NFT
Not yet minted

Create a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.

5 SUSD one-off · no wallet required
Sign in to mint
Abstract
Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and 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 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 vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, cultures and DNA sequencing for VVC, and a composite of NAAT and culture for The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the species group, 4% for VVC due to , and 10% for 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 species group; 84.7% and 99.1% for ; and 96.5% and 95.1% for 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 diagnostic NAATs that can detect the main causes of vaginitis.
Reference Key
schwebke2020clinicaljournal Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Schwebke, Jane R;Taylor, Stephanie N;Ackerman, Ronald;Schlaberg, Robert;Quigley, Neil B;Gaydos, Charlotte A;Chavoustie, Steven E;Nyirjesy, Paul;Remillard, Carmelle V;Estes, Philip;McKinney, Byron;Getman, Damon K;Clark, Craig;
Journal Journal of clinical microbiology
Year 2020
DOI
e01643-19
URL
Keywords
specificity sensitivity candidiasis diagnostic accuracy trichomoniasis amsel criteria aptima nugent score bacterial vaginosis clinician’s diagnosis molecular test

Citations

No citations found. To add a citation, contact the admin at info@scimatic.org

Comments

No comments yet. Be the first to comment on this article.