Evidence map›Paper›PMID 26792465›Full record

ArticleThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease2016

Redefining MTBDRplus test results: what do indeterminate results actually mean?

C Nikam, R Patel, M Sadani, K Ajbani, M Kazi, R Soman, A Shetty, S B Georghiou, T C Rodwell, A Catanzaro and 1 more

Abstract readComparative StudyEvaluation Study
In one paragraph

Article in The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

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

  1. Pooled it
  2. Article
  3. Effectiveness of GenoType MTBDRThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2021
    Article
  4. Article
  5. Article
  6. Article
  7. Some Synonymous and NonsynonymousAntimicrobial agents and chemotherapy · 2017
    Article
  8. The genotypic study of Mycobacterium tuberculosis complex resistant to isoniazid: Galicia, Spain (2008-2013).European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2016
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors.

C NikamDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
R PatelDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
M SadaniDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
K AjbaniDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
M KaziDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
R SomanDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
A ShettyDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.
S B GeorghiouDepartment of Medicine, University of California San Diego, La Jolla, California, USA.
T C RodwellDepartment of Medicine, University of California San Diego, La Jolla, California, USA.
A CatanzaroDepartment of Medicine, University of California San Diego, La Jolla, California, USA.
C RodriguesDepartment of Microbiology, P D Hinduja Hospital and Medical Research Centre, Mumbai, India.

Funding

VirologyP30AI036214 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Maile Ann Young Karris · 1994 to 2026
$78.4M
Rapid Tests for Drug Resistance to Detect Extensively Drug-Resistant TuberculosisU01AI082229 · NIAID · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI CATANZARO, ANTONINO · 2009 to 2013
$10.9M
NIAID NIH HHS P30 AI036214NIAID NIH HHS U01 AI082229
6 · The paper itself

Abstract

backgroundAlthough line-probe assays (LPAs) are promising, little research has been conducted to elucidate the true nature of indeterminate LPA results or assess the ability of these assays to perform on a wide range of clinical samples.

objectiveTo evaluate the performance of the commercially available GenoType(®) MTBDRplus LPA against conventional BACTEC™ MGIT™ 960 culture and drug susceptibility testing (DST) among 308 pulmonary tuberculosis (PTB) and 32 extra-pulmonary TB samples.

resultsInvalid LPA results (defined as those with a missing Mycobacterium tuberculosis identification band) were obtained for 18 PTB samples, which were excluded from further analysis. The sensitivity and specificity of the MTBDRplus assay for multidrug-resistant TB, based upon the results obtained for the remaining 322 samples, was respectively 95.2% and 95.1%. Of 290 PTB samples, 40 (13.7%) were indeterminate on LPA (defined as the absence of both wild-type and corresponding mutation bands) for isoniazid (INH) and/or rifampicin (RMP), and were further evaluated by pyrosequencing (PSQ). Contrary to standard LPA interpretation, INH and RMP susceptibility were confirmed by both DST and PSQ in respectively 7.5% (3/40) and 27.5% (11/40) of indeterminate samples.

conclusionPSQ was found to be a valuable and rapid technique to resolve discrepancies in LPA test results that were not interpretable.

Indexed as

Bacteriological TechniquesAntitubercular AgentsCross-Sectional StudiesDNA, BacterialDNA Mutational AnalysisDrug Resistance, Multiple, BacterialHumansMicrobial Sensitivity TestsMutationMycobacterium tuberculosisPhenotypePolymerase Chain ReactionPredictive Value of TestsReproducibility of ResultsSputumTuberculosis, Multidrug-ResistantAntitubercular AgentsDNA, Bacterial

Identifiers

PMID26792465
PMCPMC4874811

What OpenQuestion holds

Textmetadata
LicenceTDM
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.