Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries

Andrew Mujugira, Rhoda Ashley Morrow, Connie Celum, Jairam Lingappa, Sinead Delany-Moretlwe, Kenneth H. Fife, Renee Heffron, Guy De Bruyn, Brigitte Homawoo, Etienne Karita, Nelly Mugo, Bellington Vwalika, Jared M. Baeten

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Abstract

Objective: To compare the performance of the Focus HerpeSelect-2 enzyme immunoassay (EIA) with the gold standard herpes simplex virus (HSV) type 2 western blot, among HIV-1-uninfected men and women in east and southern Africa. Methods: 3399 HIV-1-uninfected women and men from seven countries in east and southern Africa were tested for HSV-2 antibody using the Focus HerpeSelect-2 EIA. The performance of the HerpesSelect-2 EIA was compared with the gold standard HSV-2-specific western blot. Results: Two-thirds (2294/3399) of participants were male and two-thirds (2242/3399) were from east Africa. By western blot testing, HSV-2 prevalence was 68%; 59% in men and 85% in women. At the manufacturer's recommended cut-off value of greater than 1.1, the HerpeSelect-2 EIA had a sensitivity of 98.3% and specificity of 80.3%. Receiver operating characteristic plot analysis indicated that the optimum cut-off was 2.1 or greater, with sensitivity 93.9% and specificity 90.5%. Diagnostic accuracy was modestly higher for southern Africa (area under the curve (AUC) 0.979, 95% CI 0.970 to 0.988) compared with east Africa (AUC 0.954, 95% CI 0.942 to 0.965; p<0.001 for southern vs east Africa). Conclusions: The Focus HerpeSelect-2 EIA has acceptable diagnostic accuracy for the determination of HSV-2 serostatus in African HIV-1-uninfected adults. An assay cut-off value of 2.1 or greater results in approximately 90% sensitivity and specificity, against a gold standard HSV-2 western blot. Diagnostic accuracy differed slightly by geographical region.

Original languageEnglish (US)
Pages (from-to)238-241
Number of pages4
JournalSexually transmitted infections
Volume87
Issue number3
DOIs
StatePublished - Apr 1 2011

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ASJC Scopus subject areas

  • Dermatology
  • Infectious Diseases

Cite this

Mujugira, A., Morrow, R. A., Celum, C., Lingappa, J., Delany-Moretlwe, S., Fife, K. H., Heffron, R., De Bruyn, G., Homawoo, B., Karita, E., Mugo, N., Vwalika, B., & Baeten, J. M. (2011). Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries. Sexually transmitted infections, 87(3), 238-241. https://doi.org/10.1136/sti.2010.047415