SidaGhanaV1, Main, Exploration, bibRecord, 000459

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 : 000459 ( Main/Exploration ); précédent : 000458; suivant : 000460

Multisite 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 ; Le Thi Houng [Viêt Nam] ; Roberto Vázquez Campuzano [Mexique] ; Jason Estes ; Jeffrey D. Klausner [États-Unis]

Source :

Open Forum Infectious Diseases [ 2328-8957 ] ; 2014.

RBID : PMC:4324189

Abstract

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.

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).

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.

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.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4324189

DOI: 10.1093/ofid/ofu015
PubMed: 25734088
PubMed Central: 4324189

Affiliations:

Birmanie, Ghana, Kenya, Mexique, Togo, Viêt Nam, États-Unis
Californie

Le document en format XML

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<author><name sortKey="Bristow, Claire C" sort="Bristow, Claire C" uniqKey="Bristow C" first="Claire C." last="Bristow">Claire C. Bristow</name>
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, California</nlm:aff>
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<author><name sortKey="Adu Sarkodie, Yaw" sort="Adu Sarkodie, Yaw" uniqKey="Adu Sarkodie Y" first="Yaw" last="Adu-Sarkodie">Yaw Adu-Sarkodie</name>
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,<country>Kenya</country>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Bukusi, Elizabeth Anne" sort="Bukusi, Elizabeth Anne" uniqKey="Bukusi E" first="Elizabeth Anne" last="Bukusi">Elizabeth Anne Bukusi</name>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Oo, Khin Yi" sort="Oo, Khin Yi" uniqKey="Oo K" first="Khin Yi" last="Oo">Khin Yi Oo</name>
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,<country>Myanmar</country>
</nlm:aff>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author><name sortKey="Pe, Eh Htoo" sort="Pe, Eh Htoo" uniqKey="Pe E" first="Eh Htoo" last="Pe">Eh Htoo Pe</name>
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,<country>Myanmar</country>
</nlm:aff>
<country xml:lang="fr">Birmanie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<author><name sortKey="Khamsay, Chanthavysouk" sort="Khamsay, Chanthavysouk" uniqKey="Khamsay C" first="Chanthavysouk" last="Khamsay">Chanthavysouk Khamsay</name>
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,<addr-line>Laos</addr-line>
</nlm:aff>
</affiliation>
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<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:aff id="af8"><addr-line>Hanoi Medical University, Hanoi</addr-line>
,<country>Vietnam</country>
</nlm:aff>
<country xml:lang="fr">Viêt Nam</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
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<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:aff id="af9"><institution>Departamento de Enfermedades Emergentes y Urgencias</institution>
,<addr-line>InDRE</addr-line>
,<country>Mexico</country>
</nlm:aff>
<country xml:lang="fr">Mexique</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Estes, Jason" sort="Estes, Jason" uniqKey="Estes J" first="Jason" last="Estes">Jason Estes</name>
<affiliation><nlm:aff id="af10"><addr-line>Department of Biostatistics, Fielding School of Public Health</addr-line>
,<institution>University of California Los Angeles</institution>
</nlm:aff>
</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:aff id="af11"><addr-line>David Geffen School of Medicine and Fielding School of Public Health</addr-line>
,<institution>University of California Los Angeles</institution>
, California</nlm:aff>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>Sociology and Social Work Department, Faculty of Social Sciences, Kwame Nkrumah University of Science and Technology, Kumasi</wicri:cityArea>
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<front><div type="abstract" xml:lang="en"><sec><title>Background.</title>
<p> 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 <italic>Treponema pallidum</italic>
 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.</p>
</sec>
<sec><title>Methods.</title>
<p> Laboratories in Ghana, Mexico, Laos, Togo, Kenya, and Myanmar participated in the evaluation during 2012–2013. Each site characterized sera using <italic>T pallidum</italic>
 particle agglutination assay or <italic>T pallidum</italic>
 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).</p>
</sec>
<sec><title>Results.</title>
<p> The sensitivity and specificity for the HIV antibody test component (<italic>n</italic>
 = 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 <italic>T pallidum</italic>
 test component (<italic>n</italic>
 = 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.</p>
</sec>
<sec><title>Conclusions.</title>
<p> 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.</p>
</sec>
</div>
</front>
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<author><name sortKey="Trock, B" uniqKey="Trock B">B Trock</name>
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<author><name sortKey="Criqui, Mh" uniqKey="Criqui M">MH Criqui</name>
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<author><name sortKey="Bien, Ch" uniqKey="Bien C">CH Bien</name>
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<author><name sortKey="Peeling, Rw" uniqKey="Peeling R">RW Peeling</name>
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<author><name sortKey="Bitarakwate, E" uniqKey="Bitarakwate E">E Bitarakwate</name>
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<author><name sortKey="Gill, M" uniqKey="Gill M">M Gill</name>
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<author><name sortKey="Garcia, P" uniqKey="Garcia P">P Garcia</name>
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<li>Ghana</li>
<li>Kenya</li>
<li>Mexique</li>
<li>Togo</li>
<li>Viêt Nam</li>
<li>États-Unis</li>
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<region><li>Californie</li>
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<tree><noCountry><name sortKey="Estes, Jason" sort="Estes, Jason" uniqKey="Estes J" first="Jason" last="Estes">Jason Estes</name>
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<country name="États-Unis"><region name="Californie"><name sortKey="Bristow, Claire C" sort="Bristow, Claire C" uniqKey="Bristow C" first="Claire C." last="Bristow">Claire C. Bristow</name>
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<name sortKey="Klausner, Jeffrey D" sort="Klausner, Jeffrey D" uniqKey="Klausner J" first="Jeffrey D." last="Klausner">Jeffrey D. Klausner</name>
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<country name="Ghana"><noRegion><name sortKey="Adu Sarkodie, Yaw" sort="Adu Sarkodie, Yaw" uniqKey="Adu Sarkodie Y" first="Yaw" last="Adu-Sarkodie">Yaw Adu-Sarkodie</name>
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<country name="Kenya"><noRegion><name sortKey="Ondondo, Raphael O" sort="Ondondo, Raphael O" uniqKey="Ondondo R" first="Raphael O." last="Ondondo">Raphael O. Ondondo</name>
</noRegion>
<name sortKey="Bukusi, Elizabeth Anne" sort="Bukusi, Elizabeth Anne" uniqKey="Bukusi E" first="Elizabeth Anne" last="Bukusi">Elizabeth Anne Bukusi</name>
<name sortKey="Ondondo, Raphael O" sort="Ondondo, Raphael O" uniqKey="Ondondo R" first="Raphael O." last="Ondondo">Raphael O. Ondondo</name>
</country>
<country name="Togo"><noRegion><name sortKey="Dagnra, Claver Anoumou" sort="Dagnra, Claver Anoumou" uniqKey="Dagnra C" first="Claver Anoumou" last="Dagnra">Claver Anoumou Dagnra</name>
</noRegion>
</country>
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<name sortKey="Pe, Eh Htoo" sort="Pe, Eh Htoo" uniqKey="Pe E" first="Eh Htoo" last="Pe">Eh Htoo Pe</name>
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<country name="Viêt Nam"><noRegion><name sortKey="Houng, Le Thi" sort="Houng, Le Thi" uniqKey="Houng L" first="Le Thi" last="Houng">Le Thi Houng</name>
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</country>
<country name="Mexique"><noRegion><name sortKey="Campuzano, Roberto Vazquez" sort="Campuzano, Roberto Vazquez" uniqKey="Campuzano R" first="Roberto Vázquez" last="Campuzano">Roberto Vázquez Campuzano</name>
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</country>
</tree>
</affiliations>
</record>

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Le SIDA au Ghana (serveur d'exploration)

Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection

Multisite Laboratory Evaluation of a Dual Human Immunodeficiency Virus (HIV)/Syphilis Point-of-Care Rapid Test for Simultaneous Detection of HIV and Syphilis Infection

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Abstract

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	Le SIDA au Ghana (serveur d'exploration)
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