New molecular test to detect organisms causing vaginitis/vaginosis

New molecular test to detect organisms causing vaginitis/vaginosis | Image Credit: © Artur Wnorowski - © Artur Wnorowski - stock.adobe.com.

A new molecular test for the detection of organisms that cause vaginitis and vaginosis demonstrated high agreement for 2 common species.

Results published in the Journal of Clinical Microbiology found that the Xpert Xpress Multiplex Vaginal Panel (MVP) test (Cepheid) achieved both a positive percent agreement, ranging from 93.6% to 99.0%, and a negative percent agreement, from 92.1% to 99.8%, for specimens from clinician-collected vaginal swabs (CVS) and self-obtained vaginal swabs (SVS).1

“This was a clinical study to gather data to support a submission to the FDA,” said author Barbara Van Der Pol, PhD, MPH, professor of medicine and public health at the University of Alabama at Birmingham (UAB) and a principal investigator of the UAB site.

The test, which the company began offering in November 2022, requires 4 simple steps that an untrained operator can perform: mixing the specimen, transferring the sample to the cartridge with a pipette, running the test, and viewing the results. Outcomes are rendered in less than 1 hour.

The study was conducted at 12 sites, including point-of-care (POC) settings, in geographically diverse US locations. All 1488 participants were enrolled in the study between March and October 2020. Subjects were biologically female patients 14 years and older with signs and/or symptoms of vaginitis/vaginosis. Most sites enrolled participants at least 18 years old.

Over half of the women enrolled were White (56.4%), and Black women represented 39.2% of the cohort. A full half of participants reported a history of bacterial vaginosis (BV).

Of the 12 sites, 10 performed both specimen collection and MVP testing, while the other 2 only collected specimens.

All but 10 of the participants were evaluable for at least 1 of the 4 MVP test results. The 3 main reasons specimens were excluded from analyses were unavailable, invalid, or incomplete comparator test results and indeterminate MVP results.

Among the evaluable study population, 1422 participants had BV, 1439 had vulvovaginal candidasis and 1407 had Trichomonas vaginalis (TV) infection.

MVP test results for BV were compared with the BD MAX Vaginal Panel (BDVP; BD [Becton, Dickinson and Company]), whereas TV outcomes were compared relative to a composite method that included results from the BDVP and a cotton swab for the InPouch TV culture system (Biomed Diagnostics).

“The MVP test worked well compared to the other commercially available products that were assessed, all of which perform better than clinical diagnosis without testing,” Van Der Pol told Contemporary OB/GYN. “Results indicate that the MVP test may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.” And there is no downside to the test, she added.

However, Van Der Pol doesn’t anticipate rapid adoption of the MVP test in clinical practice because “payers do not appear interested in identifying the causes of poor vaginal health.” A priority of health care providers “should be comprehensive vaginal health that can be achieved by accurately identifying causes of infection and managing infections,” she said. “This is a key component of women’s sexual and reproductive health.”

Disclosure:

Van Der Pol has received consulting/speaking honoraria from Abbott; Applied BioCode; BD (Becton, Dickinson and Company); BioFire; Cepheid; Hologic; Lucira Health; Roche; and Visby Medical.

Reference

Lillis RA, Parker RL, Ackerman R, et al. Clinical evaluation of a new molecular test for the detection of organisms causing vaginitis and vaginosis. J Clin Microbiol. 2023;61(3):e01748-22. doi:10.1128/jcm.01748-22