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Journal of Clinical Microbiology, January 2003, p. 318-323, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.318-323.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Validation of a Urine-Based PCR-Enzyme-Linked Immunosorbent Assay for Use in Clinical Research Settings To Detect Trichomonas vaginalis in Men

S. Cornelia Kaydos-Daniels,1 William C. Miller,1,2 Irving Hoffman,2 Topia Banda,3 Willard Dzinyemba,3 Francis Martinson,2 Myron S. Cohen,2,4 and Marcia M. Hobbs2,4*

Departments of Epidemiology,1 Medicine,2 Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,4 UNC Project, Lilongwe, Malawi3

Received 1 July 2002/ Returned for modification 12 August 2002/ Accepted 20 October 2002

Trichomonas vaginalis infection is highly prevalent worldwide and is associated with urethritis, prostatitis, and urethral strictures in men. However, the natural history and importance of T. vaginalis in men are poorly understood, in part because of difficulties in diagnosing infection. Traditional detection methods rely on culture and wet-mount microscopy, which can be insensitive and time consuming. Urethral swabs are commonly used to detect T. vaginalis in men, but discomfort from specimen collection is a barrier to large studies. One thousand two hundred twenty-five Malawian men attending sexually transmitted disease and dermatology clinics were enrolled in this cross-sectional study to validate detection by urine-based PCR-enzyme-linked immunosorbent assay (ELISA) with urine and urethral swab culture as the reference standard. This assay for detection of amplified T. vaginalis DNA in first-catch urine (<=30 ml) performed with a sensitivity of 92.7%, a specificity of 88.6%, and an adjusted specificity of 95.2% compared to culture of urethral swabs or urine sediment. For clinical research settings in which urethral swabs are not available and culture is not feasible, the urine-based PCR-ELISA may be useful for detection of trichomoniasis in men.

* Corresponding author. Mailing address: Department of Medicine, Campus Box 7030, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599. Phone: (919) 966-5050. Fax: (919) 966-6714. E-mail: mmhobbs{at}med.unc.edu.

Journal of Clinical Microbiology, January 2003, p. 318-323, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.318-323.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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