Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries
Identifieur interne : 001488 ( Istex/Corpus ); précédent : 001487; suivant : 001489Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries
Auteurs : Andrew Mujugira ; Rhoda Ashley Morrow ; Connie Celum ; Jairam Lingappa ; Sinead Delany-Moretlwe ; Kenneth H. Fife ; Renee Heffron ; Guy De Bruyn ; Brigitte Homawoo ; Etienne Karita ; Nelly Mugo ; Bellington Vwalika ; Jared M. BaetenSource :
- Sexually Transmitted Infections [ 1368-4973 ] ; 2011-04.
English descriptors
- KwdEn :
- African populations, Assay, Blot, Blot results, Cape town, Clin microbiol, Data collection, Diagnostic accuracy, East africa, Emory university, Enrolment visit, Enzyme immunoassay, Focus enzyme immunoassay, Genital ulcer disease, Geographical region, Herpes, Herpes simplex virus, Herpes simplex virus type, Immunoassay, Index value, Index values, Indiana university, Kenya, Optical density, Optimal index value, Positive result, Prevention transmission study team, Research group, Research unit, Rwanda, Rwanda zambia, Serological diagnosis, Simplex, Southern africa, Statistical analyses, Strong agreement, Susan allen, Test performance, Transm, Uganda, Western blot, Western blot results, Western blot testing, Zambia.
- Teeft :
- African populations, Assay, Blot, Blot results, Cape town, Clin microbiol, Data collection, Diagnostic accuracy, East africa, Emory university, Enrolment visit, Enzyme immunoassay, Focus enzyme immunoassay, Genital ulcer disease, Geographical region, Herpes, Herpes simplex virus, Herpes simplex virus type, Immunoassay, Index value, Index values, Indiana university, Kenya, Optical density, Optimal index value, Positive result, Prevention transmission study team, Research group, Research unit, Rwanda, Rwanda zambia, Serological diagnosis, Simplex, Southern africa, Statistical analyses, Strong agreement, Susan allen, Test performance, Transm, Uganda, Western blot, Western blot results, Western blot testing, Zambia.
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.
Url:
DOI: 10.1136/sti.2010.047415
Links to Exploration step
ISTEX:4020DD23B6310FD93A9BA85CE423CB9010E78D7BLe document en format XML
<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title>Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title><author><name sortKey="Mujugira, Andrew" sort="Mujugira, Andrew" uniqKey="Mujugira A" first="Andrew" last="Mujugira">Andrew Mujugira</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</mods:affiliation></affiliation></author><author><name sortKey="Morrow, Rhoda Ashley" sort="Morrow, Rhoda Ashley" uniqKey="Morrow R" first="Rhoda Ashley" last="Morrow">Rhoda Ashley Morrow</name><affiliation><mods:affiliation>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Lingappa, Jairam" sort="Lingappa, Jairam" uniqKey="Lingappa J" first="Jairam" last="Lingappa">Jairam Lingappa</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Delany Moretlwe, Sinead" sort="Delany Moretlwe, Sinead" uniqKey="Delany Moretlwe S" first="Sinead" last="Delany-Moretlwe">Sinead Delany-Moretlwe</name><affiliation><mods:affiliation>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Fife, Kenneth H" sort="Fife, Kenneth H" uniqKey="Fife K" first="Kenneth H" last="Fife">Kenneth H. Fife</name><affiliation><mods:affiliation>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Heffron, Renee" sort="Heffron, Renee" uniqKey="Heffron R" first="Renee" last="Heffron">Renee Heffron</name><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="De Bruyn, Guy" sort="De Bruyn, Guy" uniqKey="De Bruyn G" first="Guy" last="De Bruyn">Guy De Bruyn</name><affiliation><mods:affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Homawoo, Brigitte" sort="Homawoo, Brigitte" uniqKey="Homawoo B" first="Brigitte" last="Homawoo">Brigitte Homawoo</name><affiliation><mods:affiliation>AIDS Institute, New York State Department of Health, Albany, New York, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</mods:affiliation></affiliation></author><author><name sortKey="Karita, Etienne" sort="Karita, Etienne" uniqKey="Karita E" first="Etienne" last="Karita">Etienne Karita</name><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</mods:affiliation></affiliation></author><author><name sortKey="Mugo, Nelly" sort="Mugo, Nelly" uniqKey="Mugo N" first="Nelly" last="Mugo">Nelly Mugo</name><affiliation><mods:affiliation>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</mods:affiliation></affiliation></author><author><name sortKey="Vwalika, Bellington" sort="Vwalika, Bellington" uniqKey="Vwalika B" first="Bellington" last="Vwalika">Bellington Vwalika</name><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</mods:affiliation></affiliation></author><author><name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:4020DD23B6310FD93A9BA85CE423CB9010E78D7B</idno><date when="2011" year="2011">2011</date><idno type="doi">10.1136/sti.2010.047415</idno><idno type="url">https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001488</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001488</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a">Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title><author><name sortKey="Mujugira, Andrew" sort="Mujugira, Andrew" uniqKey="Mujugira A" first="Andrew" last="Mujugira">Andrew Mujugira</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</mods:affiliation></affiliation></author><author><name sortKey="Morrow, Rhoda Ashley" sort="Morrow, Rhoda Ashley" uniqKey="Morrow R" first="Rhoda Ashley" last="Morrow">Rhoda Ashley Morrow</name><affiliation><mods:affiliation>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Lingappa, Jairam" sort="Lingappa, Jairam" uniqKey="Lingappa J" first="Jairam" last="Lingappa">Jairam Lingappa</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="Delany Moretlwe, Sinead" sort="Delany Moretlwe, Sinead" uniqKey="Delany Moretlwe S" first="Sinead" last="Delany-Moretlwe">Sinead Delany-Moretlwe</name><affiliation><mods:affiliation>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Fife, Kenneth H" sort="Fife, Kenneth H" uniqKey="Fife K" first="Kenneth H" last="Fife">Kenneth H. Fife</name><affiliation><mods:affiliation>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</mods:affiliation></affiliation></author><author><name sortKey="Heffron, Renee" sort="Heffron, Renee" uniqKey="Heffron R" first="Renee" last="Heffron">Renee Heffron</name><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author><author><name sortKey="De Bruyn, Guy" sort="De Bruyn, Guy" uniqKey="De Bruyn G" first="Guy" last="De Bruyn">Guy De Bruyn</name><affiliation><mods:affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</mods:affiliation></affiliation></author><author><name sortKey="Homawoo, Brigitte" sort="Homawoo, Brigitte" uniqKey="Homawoo B" first="Brigitte" last="Homawoo">Brigitte Homawoo</name><affiliation><mods:affiliation>AIDS Institute, New York State Department of Health, Albany, New York, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</mods:affiliation></affiliation></author><author><name sortKey="Karita, Etienne" sort="Karita, Etienne" uniqKey="Karita E" first="Etienne" last="Karita">Etienne Karita</name><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</mods:affiliation></affiliation></author><author><name sortKey="Mugo, Nelly" sort="Mugo, Nelly" uniqKey="Mugo N" first="Nelly" last="Mugo">Nelly Mugo</name><affiliation><mods:affiliation>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</mods:affiliation></affiliation></author><author><name sortKey="Vwalika, Bellington" sort="Vwalika, Bellington" uniqKey="Vwalika B" first="Bellington" last="Vwalika">Bellington Vwalika</name><affiliation><mods:affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</mods:affiliation></affiliation></author><author><name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name><affiliation><mods:affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Sexually Transmitted Infections</title><title level="j" type="abbrev">Sex Transm Infect</title><idno type="ISSN">1368-4973</idno><idno type="eISSN">1472-3263</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2011-04">2011-04</date><biblScope unit="volume">87</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="238">238</biblScope></imprint><idno type="ISSN">1368-4973</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1368-4973</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>African populations</term><term>Assay</term><term>Blot</term><term>Blot results</term><term>Cape town</term><term>Clin microbiol</term><term>Data collection</term><term>Diagnostic accuracy</term><term>East africa</term><term>Emory university</term><term>Enrolment visit</term><term>Enzyme immunoassay</term><term>Focus enzyme immunoassay</term><term>Genital ulcer disease</term><term>Geographical region</term><term>Herpes</term><term>Herpes simplex virus</term><term>Herpes simplex virus type</term><term>Immunoassay</term><term>Index value</term><term>Index values</term><term>Indiana university</term><term>Kenya</term><term>Optical density</term><term>Optimal index value</term><term>Positive result</term><term>Prevention transmission study team</term><term>Research group</term><term>Research unit</term><term>Rwanda</term><term>Rwanda zambia</term><term>Serological diagnosis</term><term>Simplex</term><term>Southern africa</term><term>Statistical analyses</term><term>Strong agreement</term><term>Susan allen</term><term>Test performance</term><term>Transm</term><term>Uganda</term><term>Western blot</term><term>Western blot results</term><term>Western blot testing</term><term>Zambia</term></keywords><keywords scheme="Teeft" xml:lang="en"><term>African populations</term><term>Assay</term><term>Blot</term><term>Blot results</term><term>Cape town</term><term>Clin microbiol</term><term>Data collection</term><term>Diagnostic accuracy</term><term>East africa</term><term>Emory university</term><term>Enrolment visit</term><term>Enzyme immunoassay</term><term>Focus enzyme immunoassay</term><term>Genital ulcer disease</term><term>Geographical region</term><term>Herpes</term><term>Herpes simplex virus</term><term>Herpes simplex virus type</term><term>Immunoassay</term><term>Index value</term><term>Index values</term><term>Indiana university</term><term>Kenya</term><term>Optical density</term><term>Optimal index value</term><term>Positive result</term><term>Prevention transmission study team</term><term>Research group</term><term>Research unit</term><term>Rwanda</term><term>Rwanda zambia</term><term>Serological diagnosis</term><term>Simplex</term><term>Southern africa</term><term>Statistical analyses</term><term>Strong agreement</term><term>Susan allen</term><term>Test performance</term><term>Transm</term><term>Uganda</term><term>Western blot</term><term>Western blot results</term><term>Western blot testing</term><term>Zambia</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="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.</div></front></TEI><istex><corpusName>bmj</corpusName><keywords><teeft><json:string>western blot</json:string><json:string>herpes</json:string><json:string>southern africa</json:string><json:string>index value</json:string><json:string>east africa</json:string><json:string>zambia</json:string><json:string>kenya</json:string><json:string>simplex</json:string><json:string>transm</json:string><json:string>rwanda</json:string><json:string>diagnostic accuracy</json:string><json:string>immunoassay</json:string><json:string>herpes simplex virus type</json:string><json:string>uganda</json:string><json:string>western blot testing</json:string><json:string>test performance</json:string><json:string>herpes simplex virus</json:string><json:string>research group</json:string><json:string>assay</json:string><json:string>index values</json:string><json:string>susan allen</json:string><json:string>emory university</json:string><json:string>rwanda zambia</json:string><json:string>clin microbiol</json:string><json:string>enzyme immunoassay</json:string><json:string>blot results</json:string><json:string>research unit</json:string><json:string>data collection</json:string><json:string>serological diagnosis</json:string><json:string>western blot results</json:string><json:string>blot</json:string><json:string>statistical analyses</json:string><json:string>positive result</json:string><json:string>geographical region</json:string><json:string>enrolment visit</json:string><json:string>strong agreement</json:string><json:string>optimal index value</json:string><json:string>genital ulcer disease</json:string><json:string>focus enzyme immunoassay</json:string><json:string>indiana university</json:string><json:string>cape town</json:string><json:string>optical density</json:string><json:string>prevention transmission study team</json:string><json:string>african populations</json:string></teeft></keywords><author><json:item><name>Andrew Mujugira</name><affiliations><json:string>Department of Global Health, University of Washington, Seattle, Washington, USA</json:string><json:string>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</json:string></affiliations></json:item><json:item><name>Rhoda Ashley Morrow</name><affiliations><json:string>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</json:string></affiliations></json:item><json:item><name>Connie Celum</name><affiliations><json:string>Department of Global Health, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Medicine, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Epidemiology, University of Washington, Seattle, Washington, USA</json:string></affiliations></json:item><json:item><name>Jairam Lingappa</name><affiliations><json:string>Department of Global Health, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Medicine, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Pediatrics, University of Washington, Seattle, Washington, USA</json:string></affiliations></json:item><json:item><name>Sinead Delany-Moretlwe</name><affiliations><json:string>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</json:string></affiliations></json:item><json:item><name>Kenneth H Fife</name><affiliations><json:string>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</json:string></affiliations></json:item><json:item><name>Renee Heffron</name><affiliations><json:string>Department of Epidemiology, University of Washington, Seattle, Washington, USA</json:string></affiliations></json:item><json:item><name>Guy De Bruyn</name><affiliations><json:string>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</json:string></affiliations></json:item><json:item><name>Brigitte Homawoo</name><affiliations><json:string>AIDS Institute, New York State Department of Health, Albany, New York, USA</json:string><json:string>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</json:string></affiliations></json:item><json:item><name>Etienne Karita</name><affiliations><json:string>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</json:string></affiliations></json:item><json:item><name>Nelly Mugo</name><affiliations><json:string>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</json:string></affiliations></json:item><json:item><name>Bellington Vwalika</name><affiliations><json:string>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</json:string></affiliations></json:item><json:item><name>Jared M Baeten</name><affiliations><json:string>Department of Global Health, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Medicine, University of Washington, Seattle, Washington, USA</json:string><json:string>Department of Epidemiology, University of Washington, Seattle, Washington, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Africa</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>HIV-1</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>HSV-2</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Focus HerpeSelect-2 EIA</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>western blot</value></json:item></subject><articleId><json:string>sextrans47415</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>research-article</json:string></originalGenre><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.</abstract><qualityIndicators><score>6.279</score><pdfVersion>1.4</pdfVersion><pdfPageSize>595.276 x 793.701 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>5</keywordCount><abstractCharCount>1546</abstractCharCount><pdfWordCount>3043</pdfWordCount><pdfCharCount>21529</pdfCharCount><pdfPageCount>4</pdfPageCount><abstractWordCount>228</abstractWordCount></qualityIndicators><title>Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title><pmid><json:string>21307152</json:string></pmid><corporate><json:item><name>for the Partners in Prevention HSV/HIV Transmission Study Team*</name></json:item></corporate><genre><json:string>research-article</json:string></genre><host><title>Sexually Transmitted Infections</title><language><json:string>unknown</json:string></language><issn><json:string>1368-4973</json:string></issn><eissn><json:string>1472-3263</json:string></eissn><publisherId><json:string>sti</json:string></publisherId><volume>87</volume><issue>3</issue><pages><first>238</first></pages><genre><json:string>journal</json:string></genre></host><categories><wos><json:string>science</json:string><json:string>infectious diseases</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>public health & health services</json:string><json:string>public health</json:string></scienceMetrix><inist><json:string>sciences appliquees, technologies et medecines</json:string><json:string>sciences biologiques et medicales</json:string><json:string>sciences medicales</json:string></inist></categories><publicationDate>2011</publicationDate><copyrightDate>2011</copyrightDate><doi><json:string>10.1136/sti.2010.047415</json:string></doi><id>4020DD23B6310FD93A9BA85CE423CB9010E78D7B</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a">Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher scheme="https://publisher-list.data.istex.fr">BMJ Publishing Group Ltd</publisher><availability><licence><p>© 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</p></licence><p scheme="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</p></availability><date>2011-02-09</date></publicationStmt><notesStmt><note type="research-article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</note><note type="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note><note>Partners in Prevention HSV/HIV Transmission Study Team are listed in the appendix.</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a">Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title><author role="org"><orgName>for the Partners in Prevention HSV/HIV Transmission Study Team*</orgName><affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</affiliation></author><author xml:id="author-0000"><persName><forename type="first">Andrew</forename><surname>Mujugira</surname></persName><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Rhoda Ashley</forename><surname>Morrow</surname></persName><affiliation>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</affiliation></author><author xml:id="author-0002"><persName><forename type="first">Connie</forename><surname>Celum</surname></persName><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation></author><author xml:id="author-0003"><persName><forename type="first">Jairam</forename><surname>Lingappa</surname></persName><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA</affiliation></author><author xml:id="author-0004"><persName><forename type="first">Sinead</forename><surname>Delany-Moretlwe</surname></persName><affiliation>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</affiliation></author><author xml:id="author-0005"><persName><forename type="first">Kenneth H</forename><surname>Fife</surname></persName><affiliation>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</affiliation></author><author xml:id="author-0006"><persName><forename type="first">Renee</forename><surname>Heffron</surname></persName><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation></author><author xml:id="author-0007"><persName><forename type="first">Guy</forename><surname>De Bruyn</surname></persName><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</affiliation></author><author xml:id="author-0008"><persName><forename type="first">Brigitte</forename><surname>Homawoo</surname></persName><affiliation>AIDS Institute, New York State Department of Health, Albany, New York, USA</affiliation><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</affiliation></author><author xml:id="author-0009"><persName><forename type="first">Etienne</forename><surname>Karita</surname></persName><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</affiliation></author><author xml:id="author-0010"><persName><forename type="first">Nelly</forename><surname>Mugo</surname></persName><affiliation>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</affiliation></author><author xml:id="author-0011"><persName><forename type="first">Bellington</forename><surname>Vwalika</surname></persName><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</affiliation></author><author xml:id="author-0012"><persName><forename type="first">Jared M</forename><surname>Baeten</surname></persName><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation></author><idno type="istex">4020DD23B6310FD93A9BA85CE423CB9010E78D7B</idno><idno type="ark">ark:/67375/NVC-QBLCXBDH-G</idno><idno type="DOI">10.1136/sti.2010.047415</idno><idno type="href">sextrans-87-238.pdf</idno><idno type="article-id">sextrans47415</idno><idno type="PMID">21307152</idno><idno type="local">sextrans;87/3/238</idno></analytic><monogr><title level="j">Sexually Transmitted Infections</title><title level="j" type="abbrev">Sex Transm Infect</title><idno type="pISSN">1368-4973</idno><idno type="eISSN">1472-3263</idno><idno type="publisher-id">sti</idno><idno type="PublisherID-hwp">sextrans</idno><idno type="PublisherID-nlm-ta">Sex Transm Infect</idno><imprint><publisher>BMJ Publishing Group Ltd</publisher><date type="published" when="2011-04"></date><biblScope unit="volume">87</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="238">238</biblScope></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2011-02-09</date></creation><langUsage><language ident="en">en</language></langUsage><abstract><p>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.</p></abstract><textClass><keywords scheme="keyword"><list><head>keywords</head><item><term>Africa</term></item><item><term>HIV-1</term></item><item><term>HSV-2</term></item><item><term>Focus HerpeSelect-2 EIA</term></item><item><term>western blot</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2011-02-09">Created</change><change when="2011-04">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="corpus bmj" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="no"</istex:xmlDeclaration><istex:docType PUBLIC="-//NLM//DTD Journal Archiving and Interchange DTD v2.3 20070202//EN" URI="archivearticle.dtd" name="istex:docType"></istex:docType><istex:document><article article-type="research-article"><front><journal-meta><journal-id journal-id-type="hwp">sextrans</journal-id><journal-id journal-id-type="nlm-ta">Sex Transm Infect</journal-id><journal-id journal-id-type="publisher-id">sti</journal-id><journal-title>Sexually Transmitted Infections</journal-title><abbrev-journal-title abbrev-type="publisher">Sex Transm Infect</abbrev-journal-title><abbrev-journal-title>Sex Transm Infect</abbrev-journal-title><issn pub-type="ppub">1368-4973</issn><issn pub-type="epub">1472-3263</issn><publisher><publisher-name>BMJ Publishing Group Ltd</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">sextrans47415</article-id><article-id pub-id-type="doi">10.1136/sti.2010.047415</article-id><article-id pub-id-type="other">sextrans;87/3/238</article-id><article-id pub-id-type="other">sextrans;sti.2010.047415</article-id><article-id pub-id-type="pmid">21307152</article-id><article-id pub-id-type="other">238</article-id><article-id pub-id-type="other">sti.2010.047415</article-id><article-categories><subj-group subj-group-type="heading"><subject>Basic science</subject></subj-group></article-categories><title-group><article-title>Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Mujugira</surname><given-names>Andrew</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Morrow</surname><given-names>Rhoda Ashley</given-names></name><xref ref-type="aff" rid="aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Celum</surname><given-names>Connie</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>Lingappa</surname><given-names>Jairam</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="aff" rid="aff5">5</xref></contrib><contrib contrib-type="author"><name><surname>Delany-Moretlwe</surname><given-names>Sinead</given-names></name><xref ref-type="aff" rid="aff6">6</xref></contrib><contrib contrib-type="author"><name><surname>Fife</surname><given-names>Kenneth H</given-names></name><xref ref-type="aff" rid="aff7">7</xref></contrib><contrib contrib-type="author"><name><surname>Heffron</surname><given-names>Renee</given-names></name><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><name><surname>De Bruyn</surname><given-names>Guy</given-names></name><xref ref-type="aff" rid="aff8">8</xref></contrib><contrib contrib-type="author"><name><surname>Homawoo</surname><given-names>Brigitte</given-names></name><xref ref-type="aff" rid="aff9">9</xref><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Karita</surname><given-names>Etienne</given-names></name><xref ref-type="aff" rid="aff10">10</xref></contrib><contrib contrib-type="author"><name><surname>Mugo</surname><given-names>Nelly</given-names></name><xref ref-type="aff" rid="aff11">11</xref></contrib><contrib contrib-type="author"><name><surname>Vwalika</surname><given-names>Bellington</given-names></name><xref ref-type="aff" rid="aff12">12</xref></contrib><contrib contrib-type="author"><name><surname>Baeten</surname><given-names>Jared M</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="aff" rid="aff3">3</xref><xref ref-type="aff" rid="aff4">4</xref></contrib><contrib contrib-type="author"><collab>for the Partners in Prevention HSV/HIV Transmission Study Team<xref ref-type="fn" rid="fn1">*</xref></collab></contrib></contrib-group><aff id="aff1"><label>1</label>Department of Global Health, University of Washington, Seattle, Washington, USA</aff><aff id="aff2"><label>2</label>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</aff><aff id="aff3"><label>3</label>Department of Medicine, University of Washington, Seattle, Washington, USA</aff><aff id="aff4"><label>4</label>Department of Epidemiology, University of Washington, Seattle, Washington, USA</aff><aff id="aff5"><label>5</label>Department of Pediatrics, University of Washington, Seattle, Washington, USA</aff><aff id="aff6"><label>6</label>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</aff><aff id="aff7"><label>7</label>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</aff><aff id="aff8"><label>8</label>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</aff><aff id="aff9"><label>9</label>AIDS Institute, New York State Department of Health, Albany, New York, USA</aff><aff id="aff10"><label>10</label>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</aff><aff id="aff11"><label>11</label>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</aff><aff id="aff12"><label>12</label>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</aff><author-notes><corresp><label>Correspondence to</label> Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; <email>mujugira@uw.edu</email></corresp><fn id="fn1"><label>*</label><p>Partners in Prevention HSV/HIV Transmission Study Team are listed in the <xref ref-type="app" rid="app1">appendix</xref>.</p></fn></author-notes><pub-date pub-type="epub-original"><day>9</day><month>2</month><year>2011</year></pub-date><pub-date pub-type="ppub"><month>4</month><year>2011</year></pub-date><pub-date pub-type="epub"><day>9</day><month>2</month><year>2011</year></pub-date><volume>87</volume><volume-id pub-id-type="other">87</volume-id><volume-id pub-id-type="other">87</volume-id><issue>3</issue><issue-id pub-id-type="other">sextrans;87/3</issue-id><issue-id pub-id-type="other">3</issue-id><issue-id pub-id-type="other">87/3</issue-id><fpage>238</fpage><history><date date-type="accepted"><day>2</day><month>1</month><year>2011</year></date></history><permissions><copyright-statement>© 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</copyright-statement><copyright-year>2011</copyright-year></permissions><self-uri content-type="pdf" xlink:role="full-text" xlink:href="sextrans-87-238.pdf"></self-uri><abstract><sec><title>Objective</title><p>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.</p></sec><sec><title>Methods</title><p>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.</p></sec><sec><title>Results</title><p>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).</p></sec><sec><title>Conclusions</title><p>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.</p></sec></abstract><kwd-group><kwd>Africa</kwd><kwd>HIV-1</kwd><kwd>HSV-2</kwd><kwd>Focus HerpeSelect-2 EIA</kwd><kwd>western blot</kwd></kwd-group></article-meta></front></article></istex:document></istex:metadataXml><mods version="3.6"><titleInfo><title>Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title></titleInfo><titleInfo type="alternative" contentType="CDATA"><title>Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries</title></titleInfo><name type="corporate"><namePart>for the Partners in Prevention HSV/HIV Transmission Study Team*</namePart><affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</affiliation></name><name type="personal"><namePart type="given">Andrew</namePart><namePart type="family">Mujugira</namePart><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Correspondence to Dr Andrew Mujugira, International Clinical Research Center, University of Washington, Box 359927, 325 Ninth Avenue, Seattle, WA 98104, USA; mujugira@uw.edu</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rhoda Ashley</namePart><namePart type="family">Morrow</namePart><affiliation>Department of Laboratory Medicine, University of Washington, Seattle, Washington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Connie</namePart><namePart type="family">Celum</namePart><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jairam</namePart><namePart type="family">Lingappa</namePart><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Pediatrics, University of Washington, Seattle, Washington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sinead</namePart><namePart type="family">Delany-Moretlwe</namePart><affiliation>Reproductive Health and HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth H</namePart><namePart type="family">Fife</namePart><affiliation>Department of Medicine, Indiana University, Indianapolis, Indiana, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Renee</namePart><namePart type="family">Heffron</namePart><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Guy</namePart><namePart type="family">De Bruyn</namePart><affiliation>Perinatal HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Brigitte</namePart><namePart type="family">Homawoo</namePart><affiliation>AIDS Institute, New York State Department of Health, Albany, New York, USA</affiliation><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Etienne</namePart><namePart type="family">Karita</namePart><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Kigali, Rwanda</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Nelly</namePart><namePart type="family">Mugo</namePart><affiliation>Department of Obstetrics and Gynecology, University of Nairobi and Kenyatta National Hospital, Nairobi, Kenya</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bellington</namePart><namePart type="family">Vwalika</namePart><affiliation>Rwanda-Zambia HIV Research Group (RZHRG), Lusaka, Zambia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jared M</namePart><namePart type="family">Baeten</namePart><affiliation>Department of Global Health, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Medicine, University of Washington, Seattle, Washington, USA</affiliation><affiliation>Department of Epidemiology, University of Washington, Seattle, Washington, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="research-article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-1JC4F85T-7">research-article</genre><originInfo><publisher>BMJ Publishing Group Ltd</publisher><dateIssued encoding="w3cdtf">2011-04</dateIssued><dateCreated encoding="w3cdtf">2011-02-09</dateCreated><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="iso639-2b">eng</languageTerm><languageTerm type="code" authority="rfc3066">en</languageTerm></language><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.</abstract><note type="footnotes">Partners in Prevention HSV/HIV Transmission Study Team are listed in the appendix.</note><subject><genre>keywords</genre><topic>Africa</topic><topic>HIV-1</topic><topic>HSV-2</topic><topic>Focus HerpeSelect-2 EIA</topic><topic>western blot</topic></subject><relatedItem type="host"><titleInfo><title>Sexually Transmitted Infections</title></titleInfo><titleInfo type="abbreviated"><title>Sex Transm Infect</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1368-4973</identifier><identifier type="eISSN">1472-3263</identifier><identifier type="PublisherID">sti</identifier><identifier type="PublisherID-hwp">sextrans</identifier><identifier type="PublisherID-nlm-ta">Sex Transm Infect</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>87</number></detail><detail type="issue"><caption>no.</caption><number>3</number></detail><extent unit="pages"><start>238</start></extent></part></relatedItem><identifier type="istex">4020DD23B6310FD93A9BA85CE423CB9010E78D7B</identifier><identifier type="ark">ark:/67375/NVC-QBLCXBDH-G</identifier><identifier type="DOI">10.1136/sti.2010.047415</identifier><identifier type="href">sextrans-87-238.pdf</identifier><identifier type="ArticleID">sextrans47415</identifier><identifier type="PMID">21307152</identifier><identifier type="local">sextrans;87/3/238</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-7M42M2QJ-2">bmj</recordContentSource><recordOrigin>© 2011, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/metadata/json</uri></json:item></metadata><annexes><json:item><extension>jpeg</extension><original>true</original><mimetype>image/jpeg</mimetype><uri>https://api.istex.fr/document/4020DD23B6310FD93A9BA85CE423CB9010E78D7B/annexes/jpeg</uri></json:item></annexes><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/SidaSubSaharaV1/Data/Istex/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001488 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Istex/Corpus/biblio.hfd -nk 001488 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Sante
|area= SidaSubSaharaV1
|flux= Istex
|étape= Corpus
|type= RBID
|clé= ISTEX:4020DD23B6310FD93A9BA85CE423CB9010E78D7B
|texte= Performance of the Focus HerpeSelect-2 enzyme immunoassay for the detection of herpes simplex virus type 2 antibodies in seven African countries
}}
| This area was generated with Dilib version V0.6.32. |  |