Biraro S., Mayaud P., Morrow R.A., Grosskurth H., Weiss H.A.
Medical Research Council (MRC), Uganda Virus Research Institute (UVRI), Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda; MRC Tropical Epidemiology Group, Infectious Disease Epidemiology Unit, Department of Epidemiology and Population Health, London, United Kingdom; Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; Department of Laboratory Medicine, University of Washington, Seattle, WA, United States
Biraro, S., Medical Research Council (MRC), Uganda Virus Research Institute (UVRI), Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda, MRC Tropical Epidemiology Group, Infectious Disease Epidemiology Unit, Department of Epidemiology and Population Health, London, United Kingdom; Mayaud, P., Clinical Research Unit, Department of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom; Morrow, R.A., Department of Laboratory Medicine, University of Washington, Seattle, WA, United States; Grosskurth, H., Medical Research Council (MRC), Uganda Virus Research Institute (UVRI), Uganda Research Unit on AIDS, PO Box 49, Entebbe, Uganda, MRC Tropical Epidemiology Group, Infectious Disease Epidemiology Unit, Department of Epidemiology and Population Health, London, United Kingdom; Weiss, H.A., MRC Tropical Epidemiology Group, Infectious Disease Epidemiology Unit, Department of Epidemiology and Population Health, London, United Kingdom
Background: Several commercial type-specific serologic tests are available for herpes simplex virus type 2 (HSV-2). Poor specificity of some tests has been reported on samples from sub-Saharan Africa. Methods: To summarize the performance of the tests using samples from sub-Saharan Africa, we conducted a systematic review of publications reporting performance of commercially available HSV-2 tests against a gold standard (Western Blot or monoclonal antibody-blocking EIA). We used random-effects meta-analyses to summarize sensitivity and specificity of the 2 most commonly evaluated tests, Kalon gG2 enzyme-linked immunosorbent assay (ELISA), and Focus HerpeSelect HSV-2 ELISA. Results: We identified 10 eligible articles that included 21 studies of the performance of Focus, and 12 of Kalon. The primary analyses included studies using the manufacturersÊ cut-offs (index value = 1.1). Focus had high sensitivity (random effects summary estimate 99%, 95% confidence interval [CI]: 99%-100%) but low specificity (69%, 95% CI: 59%-80%). Kalon had sensitivity of 95% (95% CI: 93%-97%) and specificity of 91% (95% CI: 86%-95%). Specificity of Focus was significantly lower (P = 0.002) among HIV-positive (54%, 95% CI: 40%-68%) than HIV-negative individuals (69%, 95% CI: 56%-82%). When the cut-off optical density index was increased above the recommended value of 1.1 to between 2.2 and 3.5, the specificity of Focus increased to 85% (95% CI: 77%-92%). Conclusions: Sensitivity and specificity of HSV-2 tests used in sub-Saharan Africa vary by setting, and are lower than reported from studies in the United States and Europe. Increasing the cut-off optical density index may improve test performance. Evaluation of test performance in a given setting may help deciding which test is most appropriate. Copyright © 2011 American Sexually Transmitted Diseases All rights reserved.
immunoglobulin G2; monoclonal antibody; virus antibody; Africa; article; blood sampling; diagnostic test accuracy study; enzyme linked immunosorbent assay; Europe; gold standard; Herpes simplex virus 2; human; Human immunodeficiency virus infected patient; immunoassay; meta analysis; publication; sensitivity and specificity; systematic review; task performance; United States; Western blotting; Africa South of the Sahara; Antibodies, Viral; Blotting, Western; Enzyme-Linked Immunosorbent Assay; Europe; Herpes Genitalis; Herpesvirus 2, Human; Humans; Immunoenzyme Techniques; Reagent Kits, Diagnostic; Sensitivity and Specificity; Serologic Tests; United States