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Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial.
J Clin Microbiol. 2011 Dec; 49(12):4106-11.JC

Abstract

Trichomoniasis is a common sexually transmitted disease associated with preterm birth, low birth weight, and increased susceptibility to infection with other pathogenic sexually transmitted microorganisms. Nucleic acid amplification tests for Trichomonas vaginalis have improved sensitivity for detecting infected individuals compared to existing culture-based methods. This prospective, multicenter U.S. clinical trial evaluated the performance of the automated Aptima T. vaginalis assay for detecting T. vaginalis in 1,025 asymptomatic and symptomatic women. Vaginal swab, endocervical swab, ThinPrep PreservCyt, and urine specimens were collected. Subject infection status was determined by wet-mount microscopy and culture. Aptima T. vaginalis assay performance was determined for each specimen type by comparison to subject infection status. Of 933 subjects analyzed, 59.9% were symptomatic. Aptima T. vaginalis clinical sensitivity and specificity were, respectively, 100% and 99.0% for vaginal swabs, 100% and 99.4% for endocervical swabs, 100% and 99.6% in ThinPrep samples, and 95.2% and 98.9% in urine specimens. Aptima T. vaginalis performance levels were similar in asymptomatic and symptomatic subjects. This study validates the clinical performance of the Aptima T. vaginalis assay for screening asymptomatic and symptomatic women for T. vaginalis infection.

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Authors+Show Affiliations

Schwebke JR
Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.
Hobbs MM
No affiliation info available
Taylor SN
No affiliation info available
Sena AC
No affiliation info available
Catania MG
No affiliation info available
Weinbaum BS
No affiliation info available
Johnson AD
No affiliation info available
Getman DK
No affiliation info available
Gaydos CA
No affiliation info available

MeSH

AdolescentAdultAgedAutomationCervix UteriFemaleHumansMiddle AgedMolecular Diagnostic TechniquesParasitologyProspective StudiesSensitivity and SpecificityTrichomonas VaginitisTrichomonas vaginalisUnited StatesUrineVaginaYoung Adult

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

21940475

Citation

Schwebke, Jane R., et al. "Molecular Testing for Trichomonas Vaginalis in Women: Results From a Prospective U.S. Clinical Trial." Journal of Clinical Microbiology, vol. 49, no. 12, 2011, pp. 4106-11.
Schwebke JR, Hobbs MM, Taylor SN, et al. Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. J Clin Microbiol. 2011;49(12):4106-11.
Schwebke, J. R., Hobbs, M. M., Taylor, S. N., Sena, A. C., Catania, M. G., Weinbaum, B. S., Johnson, A. D., Getman, D. K., & Gaydos, C. A. (2011). Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. Journal of Clinical Microbiology, 49(12), 4106-11. https://doi.org/10.1128/JCM.01291-11
Schwebke JR, et al. Molecular Testing for Trichomonas Vaginalis in Women: Results From a Prospective U.S. Clinical Trial. J Clin Microbiol. 2011;49(12):4106-11. PubMed PMID: 21940475.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Molecular testing for Trichomonas vaginalis in women: results from a prospective U.S. clinical trial. AU - Schwebke,Jane R, AU - Hobbs,Marcia M, AU - Taylor,Stephanie N, AU - Sena,Arlene C, AU - Catania,Michael G, AU - Weinbaum,Barbara S, AU - Johnson,Ann D, AU - Getman,Damon K, AU - Gaydos,Charlotte A, Y1 - 2011/09/21/ PY - 2011/9/24/entrez PY - 2011/9/24/pubmed PY - 2012/3/2/medline SP - 4106 EP - 11 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 49 IS - 12 N2 - Trichomoniasis is a common sexually transmitted disease associated with preterm birth, low birth weight, and increased susceptibility to infection with other pathogenic sexually transmitted microorganisms. Nucleic acid amplification tests for Trichomonas vaginalis have improved sensitivity for detecting infected individuals compared to existing culture-based methods. This prospective, multicenter U.S. clinical trial evaluated the performance of the automated Aptima T. vaginalis assay for detecting T. vaginalis in 1,025 asymptomatic and symptomatic women. Vaginal swab, endocervical swab, ThinPrep PreservCyt, and urine specimens were collected. Subject infection status was determined by wet-mount microscopy and culture. Aptima T. vaginalis assay performance was determined for each specimen type by comparison to subject infection status. Of 933 subjects analyzed, 59.9% were symptomatic. Aptima T. vaginalis clinical sensitivity and specificity were, respectively, 100% and 99.0% for vaginal swabs, 100% and 99.4% for endocervical swabs, 100% and 99.6% in ThinPrep samples, and 95.2% and 98.9% in urine specimens. Aptima T. vaginalis performance levels were similar in asymptomatic and symptomatic subjects. This study validates the clinical performance of the Aptima T. vaginalis assay for screening asymptomatic and symptomatic women for T. vaginalis infection. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/21940475/Molecular_testing_for_Trichomonas_vaginalis_in_women:_results_from_a_prospective_U_S__clinical_trial_ L2 - https://journals.asm.org/doi/10.1128/JCM.01291-11?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -
Grapherence [↓54 ↑21]

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