Methods: Between Sept 2009-Jan 2011, participants were enrolled in different venues in 3 cities: Boston (Massachusetts General Hospital), Sexually Transmitted Disease (STD) Unit, HIV outpatient practice, Obstetrics Practice; Baltimore (Johns Hopkins University) STD Unit; New York City Commercial Sex Venues/bathhouse a HIV testing site of Bellevue Hospital Center. Serum was tested by Western Blot (WB) and 6 FDA approved serologic assays for HSV-1 and HSV-2: BioRad, DiaSorin, Euroimmun, Focus, Zeus, and Biokit (HSV-2 only). Sensitivity, specificity, positive and negative predictive values were determined for each assay using WB as the gold standard for the entire cohort and subgroups (HIV-positive men, pregnant women, 3 age groups (<18-29; 30-39; 40+), white men, non-white men, white women, and non-white women). Univariate and multivariable logistic regression models were used to evaluate the effect of race, gender, age, HIV status and pregnancy status on the sensitivity and specificity of the assays.
Results: 2,358 participants were enrolled. 77 were excluded due to equivocal WB tests. 61% were male; 51% were Caucasian; 32% African American and 8% Hispanic. Seroprevalence by WB for HSV-1 was 60.6% (1382) and 21.7% (495) for HSV-2. In evaluating the entire cohort the sensitivities of the assays ranged from 84.1– 88.9% (HSV-1) and 84.0 – 98.8% (HSV-2); specificities from 82.5 – 99.0% (HSV-1) and 92.4 – 97.7% (HSV-2). PPV from 88.3-99.2%(HSV-1) and 77.5-92.3%(HSV-2); NPV from 80.2-84.8%(HSV-1) and 96.1-99.7%(HSV-2). Assay performance varied among subgroups. Sensitivity of HSV1 assays tended to be lower among white compared to nonwhite participants. In univariate analyses, HSV-2 WB positivity decreased the specificity of Zeus, Euroimmun, and Biorad HSV-1 assays (p<0.05).
Conclusion: For both HSV-1, and HSV-2, Biorad, DiaSorin, Focus and Zeus assays had comparable sensitivity and specificity. Sensitivity of most assays was lower for HSV-1 than for HSV-2. Test performance varied considerably between patient subgroups.
A. Rompalo, None
L. Riley, None
D. Daskalakis, None
R. Morrow, None
H. Lee, None
A. Shui, None
C. Gaydos, Abbott/Ibis: Grant Investigator , Research support
B. Detrick, None
E. Rosenberg, None
D. Crochiere, None
K. Cunningham, None
H. Bradley, None
L. Markowitz, None
F. Xu, None
D. Felsenstein, Focus: Investigator , Research support
Alere/Zeus: Investigator , Research support
BioRad: Investigator , Research support
Biokit: Investigator , Research support
Euroimmun: Investigator , Research support
Diasorin: Investigator , Research support
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