CVI Accepts, published online ahead of print on 3 October 2007

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Clin. Vaccine Immunol. doi:10.1128/CVI.00120-07
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

The Effect of STD Co-Infections on the Performance of Three Commercially Available Immunosorbent Assays for Herpes Simplex Virus Type 2 Antibody in Men Attending Baltimore City STD Clinics

Jean Summerton, Melissa Riedesel, Oliver Laeyendecker, Charlotte Gaydos, Nancy E. Maldeis, Andrew Hardick, Rhoda Ashley Morrow, and Thomas C. Quinn^*

The Johns Hopkins University, School of Medicine, Division of Infectious Diseases, Baltimore, MD; National Institute of Allergy and Infectious Diseases, National Institutes of Health, Baltimore, MD; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; Department of Laboratory Medicine, University of Washington, Seattle, WA

^* To whom correspondence should be addressed. Email: tquinn{at}jhmi.edu.

Two hundred seventy-nine sera samples from men attending STD clinics in Baltimore City were tested for herpes simplex virus type 2 (HSV-2) specific antibody by three immunosorbent gG-2 glycoprotein-based assays (Kalon, Focus, Biokit). All positive results were confirmed by Western blot (91/279, 32.6% HSV-2 seroprevalence). All patients were also tested for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, HIV-1 and hepatitis C virus. The Kalon assay performed very well in this population (90.8% sensitive and 99.4% specific) whereas the Focus assay had a much lower sensitivity than previously shown (82.6% sensitivity). In 19.7% of the samples the Biokit assay gave an indeterminate result. It was found that the odds of a sample having a Biokit indeterminate result, compared to a definitive positive or negative, were 3.88 times greater for subjects concurrently infected with N. gonorrhoeae after controlling for the effect of other STDs (p-value 0.001, 95% CI (1.78, 8.45)). Unfortunately, we were unable to control for HSV-1 in the regression model which, based on ²analysis, might also impact the clarity of the Biokit test. The recommended index cutoff value of 1.1 by Focus and Kalon assays was found to be optimal for this population.