Prevalence and Incidence Estimation of HSV-2 by Two IgG ELISA Methods among South African Women at High Risk of HIV

Irith De Baetselier, Joris Menten, Vicky Cuylaerts, Khatija Ahmed, Jennifer Deese, Lut Van Damme and Tania Crucitti

PLOS ONE, 2015, vol. 10, issue 3, 1-12

Abstract: Introduction: Previous comparison studies of the Kalon and HerpeSelect 2 ELISA IgG assays on sub-Saharan samples have found differences in the sensitivity and specificity of these assays. Using longitudinal samples from an HIV prevention study, we compared both assays and determined the HSV-2 prevalence and incidence in a South African young female population at elevated risk of acquiring HIV. Methods: Samples at baseline were tested in both assays using the manufacturers’ guidelines (cut-off > 1.10). When non-reactive in one assay, the final visit samples were tested to determine the incidence rate. Using correlation and regression analyses, the intra- and inter-assay variabilities were assessed. Results: The prevalence rate was 41.1% and 44.9% for Kalon and HerpeSelect using the manufacturer guidelines, respectively. Agreement between the two tests were high (kappa = 0.92). The original optical density values of both assays were highly correlated (R = 0.94), but the calibrator and correspondingly cut-off index values differed between the assays. Lowering the index value cut-off for the Kalon assay by 40% (to 0.66) resulted in a HSV-2 prevalence of 43.2%, and increased agreement between the assays (to kappa = 0.96). The incidence rate was 16.3/100 Person Years using the lower cut-off for the Kalon assay. Discussion: In this longitudinal study, we showed that the performance of the two assays was very similar. After lowering the cut-off for the Kalon assay to 0.66 early infections were detected without impairing its specificity. The prevalence and incidence rates are in line with previously described rates for sub-Saharan African cohorts.

Date: 2015
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0120207

DOI: 10.1371/journal.pone.0120207

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