Performance of Commercial Herpes Simplex Virus Type-2 Antibody Tests Using Serum Samples From Sub-Saharan Africa: A Systematic Review and Meta-analysis.


Biraro, S; Mayaud, P; Morrow, RA; Grosskurth, H; Weiss, HA; (2010) Performance of Commercial Herpes Simplex Virus Type-2 Antibody Tests Using Serum Samples From Sub-Saharan Africa: A Systematic Review and Meta-analysis. Sexually transmitted diseases. ISSN 0148-5717 DOI: https://doi.org/10.1097/OLQ.0b013e3181f0bafb

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Abstract

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 manufacturers' 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.

Item Type: Article
Faculty and Department: Faculty of Infectious and Tropical Diseases > Dept of Clinical Research
Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: Centre for Global Non-Communicable Diseases (NCDs)
Tropical Epidemiology Group
PubMed ID: 20706175
Web of Science ID: 286176400015
URI: http://researchonline.lshtm.ac.uk/id/eprint/3152

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