Evidence map›Paper›PMID 30782948›Full record

Trial reportBMJ open2019

Diagnostic accuracy of the Xpert CT/NG and OSOM Trichomonas Rapid assays for point-of-care STI testing among young women in South Africa: a cross-sectional study.

Nigel Garrett, Nireshni Mitchev, Farzana Osman, Jessica Naidoo, Jienchi Dorward, Ravesh Singh, Hope Ngobese, Anne Rompalo, Koleka Mlisana, Adrian Mindel

2 registry-linked trialsAbstract readClinical Trial
In one paragraph

Trial report in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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.

NCT03407586 nacompletednot on this map

Changing the STI Care Model to Reduce Genital Inflammation and HIV Risk in South African Women

TypeinterventionalSponsorCentre for the AIDS Programme of Research in South AfricaRan2016 to 2017Enrolled267ConditionsHIV Prevention, Sexually Transmitted DiseasesArmsPoint-of-care STI testing
NCT05783856 nacompletednot on this mapstarted 2020, after this paper: background citation

Application of Vaginal-spraying LiveSpo X-secret in Supporting Treatment of Sexually Transmitted Diseases in Vietnamese Women

TypeinterventionalSponsorAnabio R&DRan2020 to 2023Enrolled100ConditionsSexually Transmitted DiseasesArmsLiveSpo X-secret, 0.9% NaCl physiological saline
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Point-of-care Tests for Chlamydia trachomatis and Neisseria gonorrhoeae: Review of the Literature.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
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  16. [Urethritis-spectrum of pathogens, diagnostics and treatment].Dermatologie (Heidelberg, Germany) · 2023
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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

10 authors.

Nigel GarrettCentre for the AIDS Programme in South Africa (CAPRISA), Durban, South Africa.
Nireshni MitchevDepartment of Microbiology, University of KwaZulu-Natal, Durban, South Africa.
Farzana OsmanCentre for the AIDS Programme in South Africa (CAPRISA), Durban, South Africa.
Jessica NaidooCentre for the AIDS Programme in South Africa (CAPRISA), Durban, South Africa.
Jienchi DorwardCentre for the AIDS Programme in South Africa (CAPRISA), Durban, South Africa.
Ravesh SinghDepartment of Microbiology, University of KwaZulu-Natal, Durban, South Africa.
Hope NgobesePrince Cyril Zulu Communicable Disease Centre, eThekwini Municipality, Durban, South Africa.
Anne RompaloMedicine, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.
Koleka MlisanaDepartment of Microbiology, University of KwaZulu-Natal, Durban, South Africa.
Adrian MindelCentre for the AIDS Programme in South Africa (CAPRISA), Durban, South Africa.

Funding

Enhanced STI management to reduce genital inflammation and HIV riskR21AI116759 · NIAID · CENTRE/AIDS PROGRAMME/RES/SOUTH AFRICA · PI GARRETT, NIGEL JOEL, ROMPALO, ANNE M · 2015 to 2016
$297k
NIAID NIH HHS R21 AI116759
6 · The paper itself

Abstract

objectivesSyndromic management of sexually transmitted infections (STIs) omits asymptomatic infections, particularly among women. Accurate point-of-care assays may improve STI care in low- and middle-income countries (LMICs). We aimed to evaluate the diagnostic performance of the Xpert

designDiagnostic evaluation conducted as part of a prospective cohort study (CAPRISA 083) between May 2016 and January 2017.

settingOne large public healthcare facility in central Durban, KwaZulu-Natal, South Africa

participants247 women, aged 18-40 years, attending for sexual and reproductive services to the clinic. Pregnant and HIV-positive women were excluded. OUTCOMES: Diagnostic performance of the Xpert CT/NG and OSOM TV assays against the laboratory-based Anyplex II STI-7 Detection. All discordant results were further tested on the Fast Track Diagnostics (FTD) STD9 assay.

resultsWe obtained vaginal swabs from 247 women and found 96.8% (239/247) concordance between Xpert and Anyplex for CT and 100% (247/247) for NG. All eight discrepant CT results were positive on Xpert, but negative on Anyplex. FTD STD9 confirmed three positive and five negative results, giving a confirmed prevalence of CT 15.0% (95% CI 10.5 to 19.4), NG 4.9% (2.2-7.5) and TV 3.2% (1.0-5.4). Sensitivity and specificity of Xpert CT/NG were 100% (100-100) and 97.6% (95.6-99.7) for CT and 100% (100-100) and 100% (100-100) for NG. The sensitivity and specificity of OSOM TV were 75.0% (45.0-100) and 100% (100-100).

conclusionThe Xpert CT/NG showed high accuracy among young South African women and combined with the OSOM TV proved a useful tool in this high HIV/STI burden setting. Further implementation and cost-effectiveness studies are needed to assess the potential role of this assay for diagnostic STI testing in LMICs. TRIAL REGISTRATION NUMBER: NCT03407586; Pre-results.

Indexed as

Chlamydia trachomatisNeisseria gonorrhoeaePoint-of-Care TestingTrichomonas vaginalisAdolescentAdultAmbulatory Care FacilitiesChlamydia InfectionsCross-Sectional StudiesFemaleGonorrheaHumansProspective StudiesSensitivity and SpecificitySexually Transmitted DiseasesSouth Africapoint-of-care testingsexually transmitted infectionsSouth AfricaXpert CT/NG

Identifiers

PMID30782948
PMCPMC6367982

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

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.