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Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries
  1. Andrew Mujugira1,
  2. Rhoda Ashley Morrow2,
  3. Connie Celum1,3,4,
  4. Jairam Lingappa1,3,5,
  5. Sinead Delany-Moretlwe6,
  6. Kenneth H Fife7,
  7. Renee Heffron4,
  8. Guy De Bruyn8,
  9. Brigitte Homawoo9,10,
  10. Etienne Karita10,
  11. Nelly Mugo11,
  12. Bellington Vwalika12,
  13. Jared M Baeten1,3,4,
  14. for the Partners in Prevention HSV/HIV Transmission Study Team
  1. 1Department of Global Health, University of Washington, Seattle, Washington, USA
  2. 2Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA
  3. 3Department of Medicine, University of Washington, Seattle, Washington, USA
  4. 4Department of Epidemiology, University of Washington, Seattle, Washington, USA
  5. 5Department of Pediatrics, University of Washington, Seattle, Washington, USA
  6. 6Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa
  7. 7Department of Medicine, Indiana University, Indianapolis, Indiana, USA
  8. 8Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa
  9. 9AIDS Institute, New York State Department of Health, Albany, New York, USA
  10. 10Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda
  11. 11Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya
  12. 12Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia
  1. Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira{at}uw.edu

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.

  • Africa
  • HIV-1
  • HSV-2
  • Focus HerpeSelect-2 EIA
  • western blot

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Footnotes

  • Funding This study was supported through research grants from the Bill & Melinda Gates Foundation (grant ID 26469) and the US National Institutes of Health (National Institute of Allergy and Infectious Diseases grant P01 AI030731). The funders played no role in design, data collection, analysis, interpretation, or writing of the report.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the University of Washington, Human Subjects Division and all collaborating site institutions.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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