Evidence map›Paper›PMID 25734088›Full record

ArticleOpen forum infectious diseases2014

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

Claire C Bristow, Yaw Adu-Sarkodie, Raphael O Ondondo, Elizabeth Anne Bukusi, Claver Anoumou Dagnra, Khin Yi Oo, Eh Htoo Pe, Chanthavysouk Khamsay, Le Thi Houng, Roberto Vázquez Campuzano and 2 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Open forum infectious diseases, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  14. An evaluation of the SD Bioline HIV/syphilis duo test.International journal of STD & AIDS · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 5 countries.

Claire C BristowDepartment of Epidemiology, Fielding School of Public Health , University of California Los Angeles , California.
Yaw Adu-SarkodieDepartment of Clinical Microbiology, School of Medical Science , College of Health Sciences, Kwame Nkrumah University of Science and Technology , Kumasi , Ghana.
Raphael O OndondoKenya 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.
Elizabeth Anne BukusiKenya Medical Research Institute , Nairobi , Kenya.
Claver Anoumou DagnraCentre National de Référence des Tests VIH, Laboratoire de Microbiologie , Lomé , Togo.
Khin Yi OoNational Health Laboratory, Yangon , Myanmar.
Eh Htoo PeNational Health Laboratory, Yangon , Myanmar.
Chanthavysouk KhamsayNMCH, Vientiane Capital , Laos.
Le Thi HoungHanoi Medical University, Hanoi , Vietnam.
Roberto Vázquez CampuzanoDepartamento de Enfermedades Emergentes y Urgencias , InDRE , Mexico.
Jason EstesDepartment of Biostatistics, Fielding School of Public Health , University of California Los Angeles.
Jeffrey D KlausnerDavid Geffen School of Medicine and Fielding School of Public Health , University of California Los Angeles , California.
University of California, Los Angeles · USNational Management Degree College · MMHanoi Medical University · VNJomo Kenyatta University of Agriculture and Technology · KEKenya Medical Research Institute · KEKwame Nkrumah University of Science and Technology · GH

Funding

UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI RAPHAEL J LANDOVITZ · 1997 to 2026
$53.5M
Virology CoreP30AI028697 · NIAID · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI MITSUYASU, RONALD T. · 1991 to 2018
$39.9M
NIAID NIH HHS P30 AI028697NIMH NIH HHS P30 MH058107
6 · The paper itself

Abstract

backgroundRecently, 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.

methodsLaboratories 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).

resultsThe 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.

conclusionsThe 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.

Indexed as

Dual testingHIVrapid testSyphilistest evaluation

Identifiers

PMID25734088
PMCPMC4324189
OpenAlexW2153700264

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.