Evidence map›Paper›PMID 29410366›Full record

ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2018

Performance of the TB-LAMP diagnostic assay in reference laboratories: Results from a multicentre study.

Thu Hang Pham, Jonathan Peter, Fernanda C Q Mello, Tommy Parraga, Nguyen Thi Ngoc Lan, Pamela Nabeta, Eloise Valli, Tatiana Caceres, Keertan Dheda, Susan E Dorman and 3 more

Abstract readMulticenter Study
In one paragraph

Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 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.

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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  8. TB testing in HIV-positive patients prior to antiretroviral treatment.The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2022
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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

13 authors.

Thu Hang PhamPham Ngoc Thach Tuberculosis and Lung Disease Hospital, Ho Chi Minh, Vietnam.
Jonathan PeterLung Infection and Immunity Unit, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Fernanda C Q MelloThoracic Diseases Institute, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
Tommy ParragaUniversidad Peruana Cayetano Heredia, Instituto de Medicina Tropical Alexander von Humboldt, Lima, Peru.
Nguyen Thi Ngoc LanPham Ngoc Thach Tuberculosis and Lung Disease Hospital, Ho Chi Minh, Vietnam.
Pamela NabetaFoundation for Innovative New Diagnostics, Geneva, Switzerland. Electronic address: pamela.nabeta@finddx.org.
Eloise ValliFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Tatiana CaceresUniversidad Peruana Cayetano Heredia, Instituto de Medicina Tropical Alexander von Humboldt, Lima, Peru.
Keertan DhedaLung Infection and Immunity Unit, Department of Medicine and UCT Lung Institute, University of Cape Town, Cape Town, South Africa.
Susan E DormanJohns Hopkins University School of Medicine, Baltimore, MD, USA.
Doris HillemannForschungszentrum, Borstel, Germany.
Christen M GrayFoundation for Innovative New Diagnostics, Geneva, Switzerland.
Mark D PerkinsFoundation for Innovative New Diagnostics, Geneva, Switzerland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the diagnostic performance of TB-LAMP, a manual molecular tuberculosis (TB) detection method, and provide comparison to the Xpert MTB/RIF assay.

methodsIn a large multicentre study, two sputum samples were collected from participants with TB symptoms in reference laboratories in Peru, South Africa, Brazil, and Vietnam. Each sample was tested with TB-LAMP. The reference standard consisted of four direct smears, four cultures, and clinical and radiological findings. Individuals negative on conventional tests were followed up after 8 weeks. The Xpert MTB/RIF assay was performed on fresh or frozen samples as a molecular test comparison.

resultsA total of 1036 adults with suspected TB were enrolled. Among 375 culture-confirmed TB cases with 750 sputum samples, TB-LAMP detected 75.6% (95% confidence interval (CI) 71.8-79.4%), including 97.9% (95% CI 96.4-99.4%) of smear-positive TB samples and 46.6% (95% CI 40.6-52.7%) of smear-negative TB samples. Specificity in 477 culture-negative participants not treated for TB (954 sputum samples) was 98.7% (95% CI 97.9-99.6%). TB-LAMP test results were indeterminate in 0.3% of cases.

conclusionsTB-LAMP detects nearly all smear-positive and half of smear-negative TB cases and has a high specificity when performed in reference laboratories. Performance was similar to the Xpert MTB/RIF assay.

Indexed as

Tuberculin TestAdolescentAdultAgedAged, 80 and overBrazilFemaleFollow-Up StudiesHumansMaleMiddle AgedPeruSensitivity and SpecificitySouth AfricaSputumTuberculosisClinical trialsMycobacterium tuberculosisPolymerase chain reaction

Identifiers

PMID29410366
PMCPMC5890091

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Registered trials

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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.