Evidence map›Paper›PMID 40130665›Full record

ArticleInternational journal of STD & AIDS2025

Validation of rapid point-of-care tests for herpes simplex virus-type 2 in rural Tanzania.

Jane K Maganga, Kristen Riley, Crispin Mukerebe, Loyce Mhango, Donald Miyaye, Peter Shigella, Myung Hee Lee, Humphrey D Mazigo, Jennifer A Downs, John M Changalucha

Abstract readValidation Study
In one paragraph

Article in International journal of STD & AIDS, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

10 authors.

Jane K MagangaMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
Kristen RileyWeill Cornell Medicine, New York, USA.ORCID 0000-0002-1322-050X
Crispin MukerebeMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
Loyce MhangoMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
Donald MiyayeMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
Peter ShigellaMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
Myung Hee LeeCenter for Global Health, Weill Cornell Medicine, New York, USA.
Humphrey D MazigoDepartment of Parasitology, Catholic University of Health and Allied Sciences, Mwanza, Tanzania.
Jennifer A DownsMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.
John M ChangaluchaMwanza Intervention Trials Unit/National Institute for Medical Research, Mwanza, Tanzania.

Funding

Genital Immune, Mucosal, and Viral Effects of Female Genital Schistosomiasis in TanzaniaR01AI168306 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI Jennifer Alzos Downs · 2022 to 2026
$3.1M
Post-Doctoral Fellowship Training in HIV Clinical InvestigationD43TW011826 · FIC · WEILL MEDICAL COLL OF CORNELL UNIV · PI Daniel W Fitzgerald, Saidi Kapiga · 2021 to 2026
$1.9M
Schistosomiasis and Women's Reproductive HealthK24AI182638 · NIAID · WEILL MEDICAL COLL OF CORNELL UNIV · PI Jennifer Alzos Downs · 2024 to 2026
$611k
FIC NIH HHS D43 TW011826NIAID NIH HHS K24 AI182638NIAID NIH HHS R01 AI168306
6 · The paper itself

Abstract

BackgroundHerpes simplex virus-type 2 (HSV-2) affects nearly 500 million people worldwide. Up to 70% of women in Tanzania are infected by age 30. Point-of-care (POC) tests to detect HSV-2 antibodies are commercially available. We validated the performance of two HSV-2 POC tests in women in rural Tanzania.MethodsBlood from 56 women was tested for HSV-2 antibodies by Biogate Labs and OnSite Duo rapid tests and Kalon HSV-2 IgG ELISA. Results obtained from the POC tests were compared with those from the ELISA to determine sensitivity, specificity, positive and negative predictive values (PPV and NPV).ResultsThe Biogate had a sensitivity and specificity of 30.3% [15.6%-48.7%] and 100% [85.2%-100%], respectively. The OnSite Duo had a sensitivity and specificity of 69.7% [51.3%-84.4%] and 87.0% [66.4%-97.2%], respectively. The PPV and NPV for the Biogate was 100% [69.2%-100%] and 50% [44.4%-55.6%], respectively. The OnSite Duo had a PPV and NPV of 88.5% [72.3%-95.8%] and 66.7% [53.8%-77.5%], respectively.ConclusionThese tests had different performance characteristics, with the Biogate having a poor sensitivity and excellent specificity, and the OnSite Duo having a slightly better sensitivity though lower specificity. Validation of POC tests is important, as they can be valuable diagnostic tools in low-resource settings.

Indexed as

Antibodies, ViralHerpes GenitalisHerpesvirus 2, HumanPoint-of-Care SystemsPoint-of-Care TestingAdolescentAdultEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GMiddle AgedPredictive Value of TestsReproducibility of ResultsRural PopulationSensitivity and SpecificityAntibodies, ViralImmunoglobulin GAfricadiagnosisequipmentHSV (Herpes Simplex Virus)women

Identifiers

PMID40130665
PMCPMC12124941

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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.