Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection.
Identifieur interne : 000497 ( PubMed/Curation ); précédent : 000496; suivant : 000498Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection.
Auteurs : Claire C. Bristow [États-Unis] ; Yaw Adu-Sarkodie [Ghana] ; Raphael O. Ondondo [Kenya] ; Elizabeth Anne Bukusi [Kenya] ; Claver Anoumou Dagnra [Togo] ; Khin Yi Oo [Birmanie] ; Eh Htoo Pe [Birmanie] ; Chanthavysouk Khamsay [Laos] ; Le Thi Houng [Viêt Nam] ; Roberto Vázquez Campuzano [Mexique] ; Jason Estes ; Jeffrey D. Klausner [États-Unis]Source :
- Open forum infectious diseases [ 2328-8957 ] ; 2014.
Abstract
Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries.
DOI: 10.1093/ofid/ofu015
PubMed: 25734088
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Jason Estes<affiliation><nlm:affiliation>Department of Biostatistics, Fielding School of Public Health , University of California Los Angeles.</nlm:affiliation><wicri:noCountry code="subField">University of California Los Angeles</wicri:noCountry></affiliation>Le document en format XML
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Klausner</name><affiliation wicri:level="2"><nlm:affiliation>David Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles , California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>David Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles </wicri:cityArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:25734088</idno><idno type="pmid">25734088</idno><idno type="doi">10.1093/ofid/ofu015</idno><idno type="wicri:Area/PubMed/Corpus">000497</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000497</idno><idno type="wicri:Area/PubMed/Curation">000497</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000497</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection.</title><author><name sortKey="Bristow, Claire C" sort="Bristow, Claire C" uniqKey="Bristow C" first="Claire C" last="Bristow">Claire C. Bristow</name><affiliation wicri:level="2"><nlm:affiliation>Department of Epidemiology, Fielding School of Public Health , University of California Los Angeles , California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>Department of Epidemiology, Fielding School of Public Health , University of California Los Angeles </wicri:cityArea></affiliation></author><author><name sortKey="Adu Sarkodie, Yaw" sort="Adu Sarkodie, Yaw" uniqKey="Adu Sarkodie Y" first="Yaw" last="Adu-Sarkodie">Yaw Adu-Sarkodie</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Microbiology, School of Medical Science , College of Health Sciences, Kwame Nkrumah University of Science and Technology , Kumasi , Ghana.</nlm:affiliation><country xml:lang="fr">Ghana</country><wicri:regionArea>Department of Clinical Microbiology, School of Medical Science , College of Health Sciences, Kwame Nkrumah University of Science and Technology , Kumasi </wicri:regionArea></affiliation></author><author><name sortKey="Ondondo, Raphael O" sort="Ondondo, Raphael O" uniqKey="Ondondo R" first="Raphael O" last="Ondondo">Raphael O. Ondondo</name><affiliation wicri:level="1"><nlm:affiliation>Kenya Medical Research Institute , Nairobi , Kenya ; Jomo Kenyatta University of Agriculture and Technology, School of Health Sciences , Institute of Tropical Medicine and Infectious Diseases , Nairobi , Kenya.</nlm:affiliation><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute , Nairobi , Kenya ; Jomo Kenyatta University of Agriculture and Technology, School of Health Sciences , Institute of Tropical Medicine and Infectious Diseases , Nairobi </wicri:regionArea></affiliation></author><author><name sortKey="Bukusi, Elizabeth Anne" sort="Bukusi, Elizabeth Anne" uniqKey="Bukusi E" first="Elizabeth Anne" last="Bukusi">Elizabeth Anne Bukusi</name><affiliation wicri:level="1"><nlm:affiliation>Kenya Medical Research Institute , Nairobi , Kenya.</nlm:affiliation><country xml:lang="fr">Kenya</country><wicri:regionArea>Kenya Medical Research Institute , Nairobi </wicri:regionArea></affiliation></author><author><name sortKey="Dagnra, Claver Anoumou" sort="Dagnra, Claver Anoumou" uniqKey="Dagnra C" first="Claver Anoumou" last="Dagnra">Claver Anoumou Dagnra</name><affiliation wicri:level="1"><nlm:affiliation>Centre National de Référence des Tests VIH, Laboratoire de Microbiologie , Lomé , Togo.</nlm:affiliation><country xml:lang="fr">Togo</country><wicri:regionArea>Centre National de Référence des Tests VIH, Laboratoire de Microbiologie , Lomé </wicri:regionArea></affiliation></author><author><name sortKey="Oo, Khin Yi" sort="Oo, Khin Yi" uniqKey="Oo K" first="Khin Yi" last="Oo">Khin Yi Oo</name><affiliation wicri:level="1"><nlm:affiliation>National Health Laboratory, Yangon , Myanmar.</nlm:affiliation><country xml:lang="fr">Birmanie</country><wicri:regionArea>National Health Laboratory, Yangon </wicri:regionArea></affiliation></author><author><name sortKey="Pe, Eh Htoo" sort="Pe, Eh Htoo" uniqKey="Pe E" first="Eh Htoo" last="Pe">Eh Htoo Pe</name><affiliation wicri:level="1"><nlm:affiliation>National Health Laboratory, Yangon , Myanmar.</nlm:affiliation><country xml:lang="fr">Birmanie</country><wicri:regionArea>National Health Laboratory, Yangon </wicri:regionArea></affiliation></author><author><name sortKey="Khamsay, Chanthavysouk" sort="Khamsay, Chanthavysouk" uniqKey="Khamsay C" first="Chanthavysouk" last="Khamsay">Chanthavysouk Khamsay</name><affiliation wicri:level="1"><nlm:affiliation>NMCH, Vientiane Capital , Laos.</nlm:affiliation><country xml:lang="fr">Laos</country><wicri:regionArea>NMCH, Vientiane Capital </wicri:regionArea></affiliation></author><author><name sortKey="Houng, Le Thi" sort="Houng, Le Thi" uniqKey="Houng L" first="Le Thi" last="Houng">Le Thi Houng</name><affiliation wicri:level="1"><nlm:affiliation>Hanoi Medical University, Hanoi , Vietnam.</nlm:affiliation><country xml:lang="fr">Viêt Nam</country><wicri:regionArea>Hanoi Medical University, Hanoi </wicri:regionArea></affiliation></author><author><name sortKey="Campuzano, Roberto Vazquez" sort="Campuzano, Roberto Vazquez" uniqKey="Campuzano R" first="Roberto Vázquez" last="Campuzano">Roberto Vázquez Campuzano</name><affiliation wicri:level="1"><nlm:affiliation>Departamento de Enfermedades Emergentes y Urgencias , InDRE , Mexico.</nlm:affiliation><country xml:lang="fr">Mexique</country><wicri:regionArea>Departamento de Enfermedades Emergentes y Urgencias , InDRE </wicri:regionArea></affiliation></author><author><name sortKey="Estes, Jason" sort="Estes, Jason" uniqKey="Estes J" first="Jason" last="Estes">Jason Estes</name><affiliation><nlm:affiliation>Department of Biostatistics, Fielding School of Public Health , University of California Los Angeles.</nlm:affiliation><wicri:noCountry code="subField">University of California Los Angeles</wicri:noCountry></affiliation></author><author><name sortKey="Klausner, Jeffrey D" sort="Klausner, Jeffrey D" uniqKey="Klausner J" first="Jeffrey D" last="Klausner">Jeffrey D. Klausner</name><affiliation wicri:level="2"><nlm:affiliation>David Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles , California.</nlm:affiliation><country>États-Unis</country><placeName><region type="state">Californie</region></placeName><wicri:cityArea>David Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles </wicri:cityArea></affiliation></author></analytic><series><title level="j">Open forum infectious diseases</title><idno type="ISSN">2328-8957</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries.</div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">25734088</PMID><DateCreated><Year>2015</Year><Month>03</Month><Day>03</Day></DateCreated><DateCompleted><Year>2015</Year><Month>03</Month><Day>03</Day></DateCompleted><DateRevised><Year>2017</Year><Month>02</Month><Day>20</Day></DateRevised><Article PubModel="Electronic-eCollection"><Journal><ISSN IssnType="Print">2328-8957</ISSN><JournalIssue CitedMedium="Print"><Volume>1</Volume><Issue>1</Issue><PubDate><Year>2014</Year><Month>Mar</Month></PubDate></JournalIssue><Title>Open forum infectious diseases</Title><ISOAbbreviation>Open Forum Infect Dis</ISOAbbreviation></Journal><ArticleTitle>Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection.</ArticleTitle><Pagination><MedlinePgn>ofu015</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1093/ofid/ofu015</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Recently, test developers have created rapid point-of-care tests that can simultaneously detect multiple infections within the same specimen using a single device. The SD BIOLINE Duo HIV/Syphilis rapid point-of-care test uses a solid-phase immunochromatographic assay to detect immunoglobulin (Ig)G, IgM, and IgA antibodies to human immunodeficiency virus (HIV)-specific antigens (HIV-1 gp41, sub O, HIV-2 gp36) and recombinant Treponema pallidum antigen (17 kDa) in human serum. This study was a multisite laboratory-based evaluation of the performance of SD BIOLINE HIV/Syphilis Duo test using previously characterized sera in 6 countries.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012-2013. Each site characterized sera using T pallidum particle agglutination assay or T pallidum hemagglutination assay and HIV enzyme immunoassay, Western blot, and/or HIV antibody rapid tests. Those gold standard test results were compared with SD BIOLINE Duo test results. We calculated the sensitivity and specificity of test performance and used the exact binomial method to calculate 95% confidence intervals (CIs).</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The sensitivity and specificity for the HIV antibody test component (n = 2336) were estimated at 99.91% (95% CI, 99.51% and 100%) and 99.67% (95% CI, 99.16% and 99.91%), respectively. For the T pallidum test component (n = 2059), the sensitivity and specificity were estimated at 99.67% (95% CI, 98.82% and 99.96%) and 99.72% (95% CI, 99.29% and 99.92%), respectively.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The sensitivity and specificity of the SD BIOLINE HIV/Syphilis Duo test were consistently high across sera specimens from 6 countries around the world. Dual rapid tests should be considered for improved HIV and syphilis screening coverage.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Bristow</LastName><ForeName>Claire C</ForeName><Initials>CC</Initials><AffiliationInfo><Affiliation>Department of Epidemiology, Fielding School of Public Health , University of California Los Angeles , California.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adu-Sarkodie</LastName><ForeName>Yaw</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Department of Clinical Microbiology, School of Medical Science , College of Health Sciences, Kwame Nkrumah University of Science and Technology , Kumasi , Ghana.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ondondo</LastName><ForeName>Raphael O</ForeName><Initials>RO</Initials><AffiliationInfo><Affiliation>Kenya Medical Research Institute , Nairobi , Kenya ; Jomo Kenyatta University of Agriculture and Technology, School of Health Sciences , Institute of Tropical Medicine and Infectious Diseases , Nairobi , Kenya.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bukusi</LastName><ForeName>Elizabeth Anne</ForeName><Initials>EA</Initials><AffiliationInfo><Affiliation>Kenya Medical Research Institute , Nairobi , Kenya.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dagnra</LastName><ForeName>Claver Anoumou</ForeName><Initials>CA</Initials><AffiliationInfo><Affiliation>Centre National de Référence des Tests VIH, Laboratoire de Microbiologie , Lomé , Togo.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oo</LastName><ForeName>Khin Yi</ForeName><Initials>KY</Initials><AffiliationInfo><Affiliation>National Health Laboratory, Yangon , Myanmar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pe</LastName><ForeName>Eh Htoo</ForeName><Initials>EH</Initials><AffiliationInfo><Affiliation>National Health Laboratory, Yangon , Myanmar.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Khamsay</LastName><ForeName>Chanthavysouk</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>NMCH, Vientiane Capital , Laos.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Houng</LastName><ForeName>Le Thi</ForeName><Initials>le T</Initials><AffiliationInfo><Affiliation>Hanoi Medical University, Hanoi , Vietnam.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Campuzano</LastName><ForeName>Roberto Vázquez</ForeName><Initials>RV</Initials><AffiliationInfo><Affiliation>Departamento de Enfermedades Emergentes y Urgencias , InDRE , Mexico.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Estes</LastName><ForeName>Jason</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, Fielding School of Public Health , University of California Los Angeles.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Klausner</LastName><ForeName>Jeffrey D</ForeName><Initials>JD</Initials><AffiliationInfo><Affiliation>David Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles , California.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>P30 AI028697</GrantID><Acronym>AI</Acronym><Agency>NIAID NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>P30 MH058107</GrantID><Acronym>MH</Acronym><Agency>NIMH NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>05</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Open Forum Infect 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| HfdSelect -Kh $EXPLOR_AREA/Data/PubMed/Curation/biblio.hfd \
| NlmPubMed2Wicri -a SidaGhanaV1
| This area was generated with Dilib version V0.6.31. |  |