Evidence map›Paper›PMID 31155318›Full record

ArticleThe Lancet. Infectious diseases2019

Novel lipoarabinomannan point-of-care tuberculosis test for people with HIV: a diagnostic accuracy study.

Tobias Broger, Bianca Sossen, Elloise du Toit, Andrew D Kerkhoff, Charlotte Schutz, Elena Ivanova Reipold, Amy Ward, David A Barr, Aurélien Macé, Andre Trollip and 8 more

Registry-linked trialOpen access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in The Lancet. Infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03187964 (Feasibility, Accuracy, and Effect of Polyvalent Point-of-care Xpert MTB/RIF Ultra and Xpert HIV-1 Viral Load Testing in HIV-positive Patients Initiating ART), which is not on this map. Cited by 133 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
133citing papers in PubMed, 10 pooled it
20.1field-weighted citation impact, top 1% 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.

NCT03187964 nacompletednot on this map

Feasibility, Accuracy, and Effect of Polyvalent Point-of-care Xpert MTB/RIF Ultra and Xpert HIV-1 Viral Load Testing in HIV-positive Patients Initiating ART: a Randomised Controlled Trial

TypeinterventionalSponsorUniversity of StellenboschRan2018 to 2022Enrolled1,053ConditionsHIV/AIDS, TB - Tuberculosis, Antiretroviral Therapy, Highly ActiveArmsPLHIV Point of Care Xpert Ultra, PLHIV Point of Care Xpert VL
3 · Its place in the literature

Who cites it

133 citing papers in PubMed, 10 syntheses or guidelines pooled it, 209 citations in OpenAlex.

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73 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 5 countries.

Tobias BrogerFIND, Geneva, Switzerland.
Bianca SossenDepartment of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Wellcome Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Elloise du ToitDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa; National Health Laboratory Service, Cape Town, South Africa.
Andrew D KerkhoffDivision of HIV, Infectious Diseases and Global Medicine, Zuckerberg San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA.
Charlotte SchutzDepartment of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Wellcome Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Elena Ivanova ReipoldFIND, Geneva, Switzerland.
Amy WardDepartment of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Wellcome Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
David A BarrWellcome Trust Liverpool Glasgow Centre for Global Health Research, University of Liverpool, Liverpool, UK.
Aurélien MacéFIND, Geneva, Switzerland.
Andre TrollipFIND, Cape Town, South Africa.
Rosie BurtonDepartment of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa; Southern African Medical Unit, Médecins sans Frontières, Cape Town, South Africa.
Stefano OngarelloFIND, Geneva, Switzerland.
Abraham PinterPublic Health Research Institute Center, New Jersey Medical School, Rutgers University, Newark, NJ, USA.
Todd L LowaryDepartment of Chemistry and Alberta Glycomics Centre, University of Alberta, Edmonton, AB, Canada.
Catharina BoehmeFIND, Geneva, Switzerland.
Mark P NicolDivision of Medical Microbiology, University of Cape Town, Cape Town, South Africa; National Health Laboratory Service, Cape Town, South Africa.
Graeme MeintjesFIND, Geneva, Switzerland; Wellcome Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Claudia M DenkingerFIND, Geneva, Switzerland. Electronic address: cdenki@gmail.com.
Foundation for Innovative New Diagnostics · CHWellcome Centre for Infectious Diseases Research in Africa · ZANational Health Laboratory Service · ZAUniversity of Cape Town · ZARutgers, The State University of New Jersey · USSan Francisco General Hospital · USUniversity of Alberta · CAUniversity of Liverpool · GB

Funding

Training in HIV Translational ResearchT32AI060530 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Diane V Havlir · 2005 to 2026
$6.4M
NIAID NIH HHS T32 AI060530Wellcome Trust
6 · The paper itself

Abstract

backgroundMost tuberculosis-related deaths in people with HIV could be prevented with earlier diagnosis and treatment. The only commercially available tuberculosis point-of-care test (Alere Determine TB LAM Ag [AlereLAM]) has suboptimal sensitivity, which restricts its use in clinical practice. The novel Fujifilm SILVAMP TB LAM (FujiLAM) assay has been developed to improve the sensitivity of AlereLAM. We assessed the diagnostic accuracy of the FujiLAM assay for the detection of tuberculosis in hospital inpatients with HIV compared with the AlereLAM assay.

methodsFor this diagnostic accuracy study, we assessed biobanked urine samples obtained from the FIND Specimen Bank and the University of Cape Town Biobank, which had been collected from hospital inpatients (aged ≥18 years) with HIV during three independent prospective cohort studies done at two South African hospitals. Urine samples were tested using FujiLAM and AlereLAM assays. The conduct and reporting of each test was done blind to other test results. The primary objective was to assess the diagnostic accuracy of FujiLAM compared with AlereLAM, against microbiological and composite reference standards (including clinical diagnoses).

findingsBetween April 18, 2018, and May 3, 2018, urine samples from 968 hospital inpatients with HIV were evaluated. The prevalence of microbiologically-confirmed tuberculosis was 62% and the median CD4 count was 86 cells per μL. Using the microbiological reference standard, the estimated sensitivity of FujiLAM was 70·4% (95% CI 53·0 to 83·1) compared with 42·3% (31·7 to 51·8) for AlereLAM (difference 28·1%) and the estimated specificity of FujiLAM was 90·8% (86·0 to 94·4) and 95·0% (87·7-98·8) for AlereLAM (difference -4·2%). Against the composite reference standard, the specificity of both assays was higher (95·7% [92·0 to 98·0] for FujiLAM vs 98·2% [95·7 to 99·6] for AlereLAM; difference -2·5%), but the sensitivity of both assays was lower (64·9% [50·1 to 76·7] for FujiLAM vs 38·2% [28·1 to 47·3] for AlereLAM; difference 26·7%).

interpretationIn comparison to AlereLAM, FujiLAM offers superior diagnostic sensitivity, while maintaining specificity, and could transform rapid point-of-care tuberculosis diagnosis for hospital inpatients with HIV. The applicability of FujiLAM for settings of intended use requires prospective assessment.

fundingGlobal Health Innovative Technology Fund, UK Department for International Development, Dutch Ministry of Foreign Affairs, Bill & Melinda Gates Foundation, German Federal Ministry of Education and Research, Australian Department of Foreign Affairs and Trade, Wellcome Trust, Department of Science and Technology and National Research Foundation of South Africa, and South African Medical Research Council.

Indexed as

LipopolysaccharidesPoint-of-Care TestingTuberculosisAdultAntigens, BacterialCD4 Lymphocyte CountFemaleHIV InfectionsHospitalsHumansMalePrevalenceProspective StudiesSensitivity and SpecificitySouth AfricaAntigens, BacteriallipoarabinomannanLipopolysaccharides

Identifiers

PMID31155318
PMCPMC6656794
OpenAlexW2947213077

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.