Herpes simplex virus type 2 antibody detection performance in Kisumu, Kenya, using the Herpeselect ELISA, Kalon ELISA, Western blot and inhibition testing

Background: In certain parts of Africa, type-specific herpes simplex virus type 2 (HSV-2) ELISAs may have limited specificity. To date, no study has been conducted to validate HerpeSelect and Kalon type-specific HSV-2 ELISAs using both the Western blot and recombinant gG ELISA inhibition testing as reference standards. Methods: A total of 120 men who were HIV seronegative (aged 18–24 years) provided blood samples. HSV-2 IgG serum antibodies were detected using four different methods: HerpeSelect HSV-2 ELISA (n = 120), Kalon HSV-2 ELISA (n = 120), University of Washington Western blot (n = 101) and a recombinant inhibition test (n = 93). Results: HSV-2 seroprevalence differed significantly by HSV-2 detection method, ranging from 24.8% with the Western blot to 69.8% with the HerpeSelect ELISA. Using the Western blot as the reference standard, the HerpesSelect had the highest sensitivity for HSV-2 antibody detection (100%) yet lowest specificity (40%). Similar results were obtained using the inhibition test as the reference standard. The sensitivity and specificity of the Kalon test versus the Western blot were 92% and 79%, respectively, and 80% and 82% versus the inhibition test. Using the inhibition test as the reference standard, the sensitivity of the Western blot appeared low (49%). Conclusions: In men in western Kenya who were HIV seronegative, the HerpeSelect and Kalon type-specific ELISAs had high sensitivities yet limited specificities using the Western blot as reference standard. Overall, the Kalon ELISA performed better than the HerpeSelect ELISA in these young men from Kisumu. Further understanding is needed for the interpretation of HSV-2 inhibition or ELISA test positive/ Western blot seronegative results. Before HSV-2 seropositivity may be reliably reported in selected areas of Africa, performance studies of HSV-2 serological assays in individual geographical areas are recommended.

[1]  O. Laeyendecker,et al.  Performance of a Commercial, Type-Specific Enzyme-Linked Immunosorbent Assay for Detection of Herpes Simplex Virus Type 2-Specific Antibodies in Ugandans , 2004, Journal of Clinical Microbiology.

[2]  Lucila Ohno-Machado,et al.  The use of receiver operating characteristic curves in biomedical informatics , 2005, J. Biomed. Informatics.

[3]  Jennifer S. Smith,et al.  Performance of focus ELISA tests for herpes simplex virus type 1 (HSV-1) and HSV-2 antibodies among women in ten diverse geographical locations. , 2004, Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases.

[4]  R. Ashley.  Type specific antibodies to HSV-1 and -2 , 1998 .

[5]  R. Hayes,et al.  Performance of Commercially Available Enzyme Immunoassays for Detection of Antibodies against Herpes Simplex Virus Type 2 in African Populations , 2004, Journal of Clinical Microbiology.

[6]  Richard J Hayes,et al.  Herpes simplex virus 2 infection increases HIV acquisition in men and women: systematic review and meta-analysis of longitudinal studies , 2006, AIDS.

[7]  J. Parry,et al.  Performance of the HerpeSelect (Focus) and Kalon Enzyme-Linked Immunosorbent Assays for Detection of Antibodies against Herpes Simplex Virus Type 2 by Use of Monoclonal Antibody-Blocking Enzyme Immunoassay and Clinicovirological Reference Standards in Brazil , 2007, Journal of Clinical Microbiology.

[8]  J. Zenilman,et al.  Performance of Focus ELISA Tests for HSV-1 and HSV-2 Antibodies Among University Students With No History of Genital Herpes , 2007, Sexually transmitted diseases.

[9]  Guofen Yan,et al.  Investigating the effects of ties on measures of concordance , 2008, Statistics in medicine.

[10]  W. Hogrefe,et al.  Detection of Herpes Simplex Virus Type 2-Specific Immunoglobulin G Antibodies in African Sera by Using Recombinant gG2, Western Blotting, and gG2 Inhibition , 2002, Journal of Clinical Microbiology.

[11]  Stephen Moses,et al.  Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial , 2007, The Lancet.

[12]  A. Wald,et al.  Time Course of Seroconversion by HerpeSelect ELISA After Acquisition of Genital Herpes Simplex Virus Type 1 (HSV-1) or HSV-2 , 2003, Sexually transmitted diseases.

[13]  O. Laeyendecker,et al.  Use of Commercial Enzyme Immunoassays To Detect Antibodies to the Herpes Simplex Virus Type 2 Glycoprotein G in a Low-Risk Population in Hanoi, Vietnam , 2007, Clinical and Vaccine Immunology.