Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis

Author:

Lillis Rebecca A.1,Parker R. Lamar2,Ackerman Ronald3,Ackerman Jamie3,Young Stephen4ORCID,Weissfeld Alice5,Trevino Ernest5,Nachamkin Irving6,Crane LaShonda7,Brown Jacqueline8,Huang Christina9,Liu Xiaohong9,Van Der Pol Barbara10ORCID

Affiliation:

1. Department of Medicine, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA

2. Unified Women’s Clinical Research, Raleigh, North Carolina, USA

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

4. TriCore Reference Laboratories, University of New Mexico HSC, Albuquerque, New Mexico

5. Microbiology Specialists Inc., Houston, Texas, USA

6. Perlman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA

7. Planned Parenthood Gulf Coast Inc., Houston, Texas, USA

8. Clinical Trials Network, Houston, Texas, USA

9. Cepheid Inc., Sunnyvale, California, USA

10. Heersink School of Medicine, University of Alabama Birmingham, Birmingham, Alabama, USA

Abstract

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States.

Funder

Cepheid

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference27 articles.

1. High Global Burden and Costs of Bacterial Vaginosis: A Systematic Review and Meta-Analysis

2. CDC. 2021. Sexually transmitted infections treatment guidelines. 70:1–197. https://www.cdc.gov/std/treatment-guidelines/STI-Guidelines-2021.pdf. Accessed 21 February 2023.

3. Vaginitis: diagnosis and treatment;Hainer BL;Am Fam Physician,2011

4. Centers for Disease Control and Prevention. 2015. Bacterial vaginosis statistics. https://www.cdc.gov/std/bv/stats.htm#print. Accessed 21 February 2023.

5. The Prevalence of Bacterial Vaginosis in the United States, 2001–2004; Associations With Symptoms, Sexual Behaviors, and Reproductive Health

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