Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study-Reference-Cited by-同舟云学术

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

Published:2020-01-28 Issue:2 Volume:58 Page:
ISSN:0095-1137
Container-title:Journal of Clinical Microbiology
language:en
Short-container-title:J Clin Microbiol

Author:

Schwebke Jane R.¹,Taylor Stephanie N.²,Ackerman Ronald³,Schlaberg Robert⁴,Quigley Neil B.⁵,Gaydos Charlotte A.⁶,Chavoustie Steven E.⁷,Nyirjesy Paul⁸,Remillard Carmelle V.⁹,Estes Philip⁹,McKinney Byron⁹,Getman Damon K.⁹,Clark Craig⁹

Affiliation:

1. University of Alabama at Birmingham, Birmingham, Alabama, USA

2. Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA

3. Comprehensive Clinical Trials, West Palm Beach, Florida, USA

4. University of Utah, Salt Lake City, Utah, USA

5. Geneuity CRS, Maryville, Tennessee, USA

6. Johns Hopkins University, Baltimore, Maryland, USA

7. Segal Trials, Miami, Florida, USA

8. Drexel University, Philadelphia, Pennsylvania, USA

9. Hologic, Inc., San Diego, California, USA

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.

Funder

HHS | NIH | National Institute of Allergy and Infectious Diseases

HHS | NIH | National Institute of Biomedical Imaging and Bioengineering

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Link

https://journals.asm.org/doi/pdf/10.1128/JCM.01643-19

Reference34 articles.

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2. Vaginitis: diagnosis and treatment;Paladine HL;Am Fam Physician,2018