Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2023 Mar 23;61(3):e0174822.
doi: 10.1128/jcm.01748-22. Epub 2023 Feb 28.

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

Rebecca A Lillis  1 , R Lamar Parker  2 , Ronald Ackerman  3 , Jamie Ackerman  3 , Stephen Young  4 , Alice Weissfeld  5 , Ernest Trevino  5 , Irving Nachamkin  6 , LaShonda Crane  7 , Jacqueline Brown  8 , Christina Huang  9 , Xiaohong Liu  9 , Barbara Van Der Pol  10
Affiliations
Observational Study

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

Rebecca A Lillis et al. J Clin Microbiol. .

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. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.

Keywords: Candida vaginitis; Trichomonas vaginalis; bacterial vaginosis; molecular diagnostics; point of care test; vaginitis diagnosis panel.

PubMed Disclaimer

Conflict of interest statement

The authors declare a conflict of interest. R.L.P., R.A., J.A., S.Y., A.W., E.T., I.N., L.C., J.B., C.H., and X.L. reported no disclosures. R.A.L. has received research funding to her institution from BioMerieux, Cepheid, Hologic, Becton Dickinson, Visby, Ortho Clinical Diagnostics, Roche, Merck, and Gilead; and has participated in Cepheid's speakers' bureau. B.V.D.P. has received grant support to her institution or consulting/speaking honorarium payments from Abbott, Applied BioCode, BD, BioFire, Cepheid, Hologic, Lucira, Roche, and Visby.

Figures

FIG 1
FIG 1
Swab Collection and Testing Workflow. One self-collected swab (SVS) was always collected first; five clinician-collected swabs (CVS) were collected, where the first 4 (Swabs 1 to 4) were collected in a randomized order; and 1 CVS (Swab 5) was always collected last and tested as needed for discrepant result investigation.
FIG 2
FIG 2
Disposition of Enrolled Participants for Self-collected Vaginal Swabs (2a) and Clinician-collected Vaginal Swabs (2b). Reasons for exclusion included unavailable/incomplete comparator test results, invalid comparator test results, incomplete Xpert test results, non-determinate Xpert test results, and incomplete specimen collection.
FIG 3
FIG 3
Single and Multi-infections based on Comparator Method Rates of infection with BV, TV, and VVC (all Candida isolates pooled) in a proportional Venn diagram.
See this image and copyright information in PMC

References

    1. Peebles K, Velloza J, Balkus JE, McClelland RS, Barnabas RV. 2019. High global burden and costs of bacterial vaginosis: a systematic review and meta-analysis. Sex Transm Dis 46:304–311. doi:10.1097/OLQ.0000000000000972. - DOI - PubMed
    1. 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.
    1. Hainer BL, Gibson MV. 2011. Vaginitis: diagnosis and treatment. Am Fam Physician 83:807–815. - PubMed
    1. Centers for Disease Control and Prevention. 2015. Bacterial vaginosis statistics. https://www.cdc.gov/std/bv/stats.htm#print. Accessed 21 February 2023.
    1. Koumans EH, Sternberg M, Bruce C, McQuillan G, Kendrick J, Sutton M, Markowitz LE. 2007. The prevalence of bacterial vaginosis in the United States, 2001–2004; associations with symptoms, sexual behaviors, and reproductive health. Sex Transm Dis 34:864–869. doi:10.1097/OLQ.0b013e318074e565. - DOI - PubMed

Publication types