Evidence map›Paper›PMID 31221109›Full record

ArticleBMC infectious diseases2019

Performance and impact of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® assays on tuberculosis case detection in Madagascar.

Niaina Rakotosamimanana, Simon Grandjean Lapierre, Vaomalala Raharimanga, Mamy Serge Raherison, Astrid M Knoblauch, Antso Hasina Raherinandrasana, Andrianantenaina Rakotoson, Julio Rakotonirina, Voahangy Rasolofo

Abstract read
In one paragraph

Article in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

9 authors.

Niaina RakotosamimananaMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar. niaina@pasteur.mg.ORCID http://orcid.org/0000-0002-2352-9797
Simon Grandjean LapierreMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0003-3646-1573
Vaomalala RaharimangaEpidemiology Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.
Mamy Serge RaherisonMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.
Astrid M KnoblauchMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.ORCID http://orcid.org/0000-0001-5943-4362
Antso Hasina RaherinandrasanaCentre hospitalier universitaire de soins et de santé publique d'Analakely, Analakely, Antananarivo, Madagascar.
Andrianantenaina RakotosonMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.
Julio RakotonirinaCentre hospitalier universitaire de soins et de santé publique d'Analakely, Analakely, Antananarivo, Madagascar.
Voahangy RasolofoMycobacteria Unit, Institut Pasteur de Madagascar, Antananarivo, Madagascar.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTuberculosis rapid molecular assays, including GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit®, are highly sensitive and specific. Such performance does not automatically translate in improved disease control and highly depends on their use, local epidemiology and the diagnostic algorithms they're implemented within. We evaluate the performance of both assays and assess their impact on additional cases notification when implemented within WHO recommended tuberculosis diagnostic algorithms in Madagascar.

methodsFive hundred forty eight presumptive pulmonary tuberculosis patients were prospectively recruited between November 2013 and December 2014 in Antananarivo, Madagascar, a high TB incidence sub-Saharan African urban setting. Both molecular assays were evaluated as first line or add-on testing following negative smear microscopy. Based on locally defined assay performance characteristics we measure the impact of both assays and WHO-recommended diagnostic algorithms on additional tuberculosis case notifications.

resultsHigh sensitivity and specificity was confirmed for both GeneXpert MTB/RIF® (86.6% (95% CI 81.1-90.7%) and 97.4% (95% CI 94.9-98.8%)) and Loopamp MTBC Detection Kit® (84.6% (95% CI 78.9-89.0%) and 98.4% (95% CI 96.2-99.4%)). Implementation of GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® increased tuberculosis diagnostic algorithms sensitivity from 73.6% (95% CI 67.1-79.3%) up to 88.1% (95% CI 82.8-91.9%). This increase was highest when molecular assays were used as add-on testing following negative smear microscopy. As add-on testing, GeneXpert MTB/RIF® and Loopamp MTBC Detection Kit® respectively improved case detection by 23.8 and 21.2% (p < 0.05).

conclusionIncluding GeneXpert MTB/RIF® or Loopamp MTBC Detection Kit® molecular assays for TB detection on sputum samples from presumptive TB cases can significantly increase case notification in TB diagnostic centers. The TB case detection rate is further increased when those tests are use as second-line follow-on testing following negative smear microscopy results. A country wide scale-up and digital integration of molecular-based TB diagnosis assays shows promises for TB control in Madagascar.

Indexed as

AdultDNA, BacterialFemaleHumansMadagascarMaleMiddle AgedMycobacterium tuberculosisNucleic Acid Amplification TechniquesReagent Kits, DiagnosticSensitivity and SpecificitySputumTuberculosis, PulmonaryDNA, BacterialReagent Kits, DiagnosticCase detectionGeneXpertLoop-mediated isothermal amplificationMolecular diagnosticsTuberculosis

Identifiers

PMID31221109
PMCPMC6585144

What OpenQuestion holds

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LicenceCC BY
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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.