Tags

Type your tag names separated by a space and hit enter

Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women.
J Clin Microbiol. 2018 02; 56(2)JC

Abstract

Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and the acquisition and transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA cleared in the United States for detection of Trichomonas vaginalis in specimens from both women and men. This study reports the results of a multicenter study recently conducted using the Xpert TV (T. vaginalis) assay to test specimens from both men and women. On-demand results were available in as little as 40 min for positive specimens. A total of 1,867 women and 4,791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV assay was compared to the patient infected status (PIS) derived from the results of InPouch TV broth culture and Aptima NAAT for T. vaginalis The diagnostic sensitivities and specificities of the Xpert TV assay for the combined female specimens (urine samples, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 to 100% and 99.4 to 99.9%, respectively. For male urine samples, the diagnostic sensitivity and specificity were 97.2% and 99.9%, respectively, compared to PIS results derived from the results of broth culture for T. vaginalis and bidirectional gene sequencing of amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV assay should result in opportunities for enhanced screening for T. vaginalis in both men and women and, hopefully, improved control of this infection.

Links

PMC Free PDF

Authors+Show Affiliations

Schwebke JR
Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA jschwebk@uabmc.edu.
Gaydos CA
Johns Hopkins University, Baltimore, Maryland, USA.
Davis T
Indiana University School of Medicine, Indianapolis, Indiana, USA.
Marrazzo J
Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Furgerson D
Planned Parenthood Mar Monte, San Jose, California, USA.
Taylor SN
Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.
Smith B
Planned Parenthood Gulf Coast, Houston, Texas, USA.
Bachmann LH
Wake Forest University Health Sciences, Winston-Salem, North Carolina, USA.
Ackerman R
Comprehensive Clinical Trials, W. Palm Beach, Florida, USA.
Spurrell T
Planned Parenthood of Southern New England, New Haven, Connecticut, USA.
Ferris D
Augusta University, Augusta, Georgia, USA.
Burnham CA
Washington University in St. Louis, St. Louis, Missouri, USA.
Reno H
Washington University in St. Louis, St. Louis, Missouri, USA.
Lebed J
Planned Parenthood Southeastern PA, Philadelphia, Pennsylvania, USA.
Eisenberg D
Planned Parenthood St. Louis Region, St. Louis, Missouri, USA.
Kerndt P
University of Southern California, Los Angeles, California, USA.
Philip S
San Francisco Public Health, San Francisco, California, USA.
Jordan J
George Washington University School of Public Health, Washington, DC, USA.
Quigley N
Geneuity, Maryville, Tennessee, USA.

MeSH

AdolescentAdultAgedFemaleHumansMaleMiddle AgedNucleic Acid Amplification TechniquesPrevalenceProspective StudiesSensitivity and SpecificitySpecimen HandlingTrichomonas InfectionsTrichomonas vaginalisUnited StatesUrineVaginaYoung Adult

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29167292

Citation

Schwebke, Jane R., et al. "Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas Vaginalis With Prospectively Collected Specimens From Men and Women." Journal of Clinical Microbiology, vol. 56, no. 2, 2018.
Schwebke JR, Gaydos CA, Davis T, et al. Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women. J Clin Microbiol. 2018;56(2).
Schwebke, J. R., Gaydos, C. A., Davis, T., Marrazzo, J., Furgerson, D., Taylor, S. N., Smith, B., Bachmann, L. H., Ackerman, R., Spurrell, T., Ferris, D., Burnham, C. A., Reno, H., Lebed, J., Eisenberg, D., Kerndt, P., Philip, S., Jordan, J., & Quigley, N. (2018). Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women. Journal of Clinical Microbiology, 56(2). https://doi.org/10.1128/JCM.01091-17
Schwebke JR, et al. Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas Vaginalis With Prospectively Collected Specimens From Men and Women. J Clin Microbiol. 2018;56(2) PubMed PMID: 29167292.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical Evaluation of the Cepheid Xpert TV Assay for Detection of Trichomonas vaginalis with Prospectively Collected Specimens from Men and Women. AU - Schwebke,Jane R, AU - Gaydos,C A, AU - Davis,T, AU - Marrazzo,J, AU - Furgerson,D, AU - Taylor,S N, AU - Smith,B, AU - Bachmann,L H, AU - Ackerman,R, AU - Spurrell,T, AU - Ferris,D, AU - Burnham,C A, AU - Reno,H, AU - Lebed,J, AU - Eisenberg,D, AU - Kerndt,P, AU - Philip,S, AU - Jordan,J, AU - Quigley,N, Y1 - 2018/01/24/ PY - 2017/07/20/received PY - 2017/10/11/accepted PY - 2017/11/24/pubmed PY - 2019/5/28/medline PY - 2017/11/24/entrez KW - NAAT KW - diagnosis KW - female KW - male KW - trichomonas JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 56 IS - 2 N2 - Trichomoniasis is the most prevalent curable sexually transmitted disease (STD). It has been associated with preterm birth and the acquisition and transmission of HIV. Recently, nucleic acid amplification tests (NAAT) have been FDA cleared in the United States for detection of Trichomonas vaginalis in specimens from both women and men. This study reports the results of a multicenter study recently conducted using the Xpert TV (T. vaginalis) assay to test specimens from both men and women. On-demand results were available in as little as 40 min for positive specimens. A total of 1,867 women and 4,791 men were eligible for inclusion in the analysis. In women, the performance of the Xpert TV assay was compared to the patient infected status (PIS) derived from the results of InPouch TV broth culture and Aptima NAAT for T. vaginalis The diagnostic sensitivities and specificities of the Xpert TV assay for the combined female specimens (urine samples, self-collected vaginal swabs, and endocervical swabs) ranged from 99.5 to 100% and 99.4 to 99.9%, respectively. For male urine samples, the diagnostic sensitivity and specificity were 97.2% and 99.9%, respectively, compared to PIS results derived from the results of broth culture for T. vaginalis and bidirectional gene sequencing of amplicons. Excellent performance characteristics were seen using both female and male specimens. The ease of using the Xpert TV assay should result in opportunities for enhanced screening for T. vaginalis in both men and women and, hopefully, improved control of this infection. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/29167292/Clinical_Evaluation_of_the_Cepheid_Xpert_TV_Assay_for_Detection_of_Trichomonas_vaginalis_with_Prospectively_Collected_Specimens_from_Men_and_Women_ DB - PRIME DP - Unbound Medicine ER -