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Journal of Clinical Microbiology, June 2008, p. 1914-1918, Vol. 46, No. 6
0095-1137/08/$08.00+0     doi:10.1128/JCM.02332-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Performance of HerpeSelect and Kalon Assays in Detection of Antibodies to Herpes Simplex Virus Type 2

Jérôme LeGoff,^1,2* Philippe Mayaud,³ Gérard Gresenguet,⁴ Helen A. Weiss,³ Khonde Nzambi,⁵ Eric Frost,⁶ Jacques Pepin,⁶ Laurent Belec,¹ and the ANRS 12-12 Study Group

Université Paris Descartes, Equipe Immunité et Biothérapie Muqueuse, Unité INSERM Internationale U743 (Immunologie Humaine), Centres de Recherches Biomédicales des Cordeliers and Laboratoire de Virologie, Hôpital Européen Georges Pompidou, Paris, France,¹ Laboratoire de Microbiologie, Hôpital Saint-Louis, Paris, France,² Clinical Research Unit, Department of Infectious and Tropical Diseases, and Infectious Diseases Epidemiology Unit, Department of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom,³ Centre National de Référence des Maladies Sexuellement Transmissibles et du SIDA de Bangui and Unité de Recherches et d'Intervention sur les Maladies Sexuellement Transmissibles et du SIDA, Faculté des Sciences de la Santé, Bangui, Central African Republic,⁴ West African Project To Combat AIDS and STDs, Accra, Ghana,⁵ Centre for International Health, University of Sherbrooke, Sherbrooke, Canada⁶

Received 4 December 2007/ Returned for modification 25 January 2008/ Accepted 21 March 2008

The performances of commercial enzyme-linked immunosorbent assays (ELISAs) in detecting herpes simplex virus type 2 (HSV-2) antibodies have been inconsistent for African and human immunodeficiency virus (HIV)-positive populations. We compared the performances of the HerpeSelect and Kalon glycoprotein G2 ELISAs for patients with genital ulcer disease in Ghana and the Central African Republic. Sera from 434 women were tested with the HerpeSelect assay, and a subsample (n = 199) was tested by the Kalon assay. Ulcer swabs and cervicovaginal lavage samples were tested for HSV-2 DNA by PCR. HSV-2-seronegative women with detectable genital HSV-2 DNA were retested for HSV-2 antibodies 14 and 28 days later by the two ELISAs. A total of 346 (80%) women were positive by HerpeSelect at baseline, and 225 (54%) had detectable genital (lesional or cervicovaginal) HSV-2 DNA. Sixty-six (19%) HerpeSelect-positive samples had low-positive index values (1.1 to 3.5), and 58% of these samples had detectable genital HSV-2 DNA. Global agreement between the two serological assays was 86%. Concordance was high (99%) for sera that were negative by HerpeSelect or had high index values (>3.5). Defining infection detected by HSV-2 DNA PCR and/or Kalon assay as true infection, 71% of sera with low-positive index values were associated with true HSV-2 infection. Twenty-five women were identified as having nonprimary first-episode genital HSV-2 infection. Rates of HSV-2 seroconversion at day 14 were 77% (10/13 patients) by HerpeSelect assay and 23% (3/13 patients) by Kalon assay, with four additional seroconversions detected by Kalon assay at day 28. HIV serostatus did not influence assay performance. Low index values obtained with the HerpeSelect assay may correspond to true HSV-2 infection, in particular to nonprimary first episodes of genital HSV-2 infection, and need to be interpreted in the context of clinical history.

Published ahead of print on 2 April 2008.

The composition of the ANRS 12-12 Study Group is detailed in Acknowledgments.