Evidence map›Paper›PMID 31976353›Full record

ArticleOpen forum infectious diseases2020

Diagnostic Accuracy of a Novel and Rapid Lipoarabinomannan Test for Diagnosing Tuberculosis Among People With Human Immunodeficiency Virus.

Stephanie Bjerrum, Tobias Broger, Rita Székely, Satoshi Mitarai, Japheth A Opintan, Ernest Kenu, Margaret Lartey, Kennedy K Addo, Kinuyo Chikamatsu, Aurélien Macé and 5 more

Open access · goldAbstract read
In one paragraph

Article in Open forum infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 9 pooled it
4.8field-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

33 citing papers in PubMed, 9 syntheses or guidelines pooled it, 49 citations in OpenAlex.

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  7. Screening tests for active pulmonary tuberculosis in children.The Cochrane database of systematic reviews · 2021
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  15. Diagnostic Accuracy of the Updated FujiLAM II Assay to Detect Tuberculosis in Outpatients With Advanced HIV Disease.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
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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

15 authors at 6 institutions in 6 countries.

Stephanie BjerrumDepartment of Clinical Research, Unit of Infectious Diseases, University of Southern Denmark, Odense, Denmark.ORCID 0000-0002-9046-6255
Tobias BrogerFIND, Geneva, Switzerland.
Rita SzékelyFIND, Geneva, Switzerland.
Satoshi MitaraiDepartment of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Japheth A OpintanDepartment of Medical Microbiology, School of Biomedical and Allied Sciences, College of Health Sciences, University of Ghana, Accra, Ghana.
Ernest KenuFevers Unit, Korle-Bu Teaching Hospital, Accra, Ghana.
Margaret LarteyDepartment of Medicine, School of Medicine and Dentistry, University of Ghana, Accra, Ghana.
Kennedy K AddoDepartment of Bacteriology, Noguchi Memorial Institute for Medical Research, University of Ghana, Accra, Ghana.
Kinuyo ChikamatsuDepartment of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Aurélien MacéFIND, Geneva, Switzerland.
Samuel G SchumacherFIND, Geneva, Switzerland.ORCID 0000-0002-6136-206X
Emmanuel MoreauFIND, Geneva, Switzerland.
Maunank ShahDepartment of Medicine, Division of Infectious Diseases, John Hopkins University School of Medicine, Baltimore, Maryland, USA.
Isik Somuncu JohansenDepartment of Clinical Research, Unit of Infectious Diseases, University of Southern Denmark, Odense, Denmark.
Claudia M DenkingerFIND, Geneva, Switzerland.
FIND · CHUniversity of Ghana · GHJapan Anti Tuberculosis Association · JPUniversity of Southern Denmark · DKJohns Hopkins University · USKorle Bu Teaching Hospital · GH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe novel Fujifilm SILVAMP TB-LAM (FujiLAM) assay detects mycobacterial lipoarabinomannan in urine and has demonstrated superior sensitivity to the Alere Determine TB-LAM Ag (AlereLAM) assay for detection of tuberculosis among hospitalized people with human immunodeficiency virus (PWH). This is the first study to evaluate the assay among a broad population referred for antiretroviral therapy including both outpatients (mainly) and inpatients.

methodsWe assessed diagnostic accuracy of FujiLAM and AlereLAM assays in biobanked urine samples from a cohort of adults referred for antiretroviral therapy in Ghana against a microbiological and a composite (including clinical judgement) reference standard, and we assessed the association of FujiLAM test positivity with mortality.

resultsWe evaluated urine samples from 532 PWH (462 outpatients, 70 inpatients). Against a microbiological reference standard, the sensitivity of FujiLAM was 74.2% (95% confidence interval [CI], 62.0-84.2) compared to 53.0% (95% CI, 40.3-65.4) for AlereLAM, a difference of 21.2% (CI, 13.1-32.5). Specificity was 89.3% (95% CI, 85.8-92.2) versus 95.6% (95% CI, 93.0-97.4) for FujiLAM and AlereLAM, a difference of -6.3% (95% CI -9.6 to -3.3). Specificity estimates for FujiLAM increased markedly to 98.8% (95% CI, 96.6-99.8) in patients with CD4 >100 cells/µL and when using a composite reference standard. FujiLAM test positivity was associated with increased cumulative risk of mortality at 6 months (hazard ratio, 4.80; 95% CI, 3.01-7.64).

conclusionsFujiLAM offers significantly increased diagnostic sensitivity in comparison to AlereLAM. Specificity estimates for FujiLAM were lower than for AlereLAM but were affected by the limited ability of the reference standard to correctly diagnose tuberculosis in individuals with low CD4 counts.

Indexed as

diagnostic accuracyHIVLAMtuberculosisurine

Identifiers

PMID31976353
PMCPMC6966242
OpenAlexW2996156497

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.