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ArticleTuberculosis and respiratory diseases2020

Diagnostic Evaluation of Non-Interpretable Results Associated with rpoB Gene in Genotype MTBDRplus Ver 2.0.

Binit Kumar Singh, Rohini Sharma, Parul Kodan, Manish Soneja, Pankaj Jorwal, Neeraj Nischal, Ashutosh Biswas, Sanjay Sarin, Ranjani Ramachandran, Naveet Wig

Open access · diamondAbstract read
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Article in Tuberculosis and respiratory diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

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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

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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

3 citing papers in PubMed, 6 citations in OpenAlex.

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4 · The record

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5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Binit Kumar SinghDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Rohini SharmaDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Parul KodanDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Manish SonejaDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Pankaj JorwalDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Neeraj NischalDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Ashutosh BiswasDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
Sanjay SarinFoundation for Innovative New Diagnostics (FIND), New Delhi, India.
Ranjani RamachandranWorld Health Organization, New Delhi, India.
Naveet WigDepartment of Medicine, All India Institute of Medical Sciences, New Delhi, India.
All India Institute of Medical Sciences · INWorld Health Organization - India · IN

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundLine probe assay (LPA) is standard diagnostic tool to detect multidrug resistant tuberculosis. Noninterpretable (NI) results in LPA (complete missing or light wild-type 3 and 8 bands with no mutation band in rpoB gene region) poses a diagnostic challenge.

methodsSputum samples obtained between October 2016 and July 2017 at the Intermediate Reference Laboratory, All India Institute of Medical Sciences Hospital, New Delhi, India were screened. Smear-positive and smear-negative culturepositive specimens were subjected to LPA Genotype MTBDRplus Ver 2.0. Smear-negative with culture-negative and culture contamination were excluded. LPA NI samples were subjected to phenotypic drug susceptibility testing (pDST) using MGIT-960 and sequencing.

resultsA total of 1,614 sputum specimens were screened and 1,340 were included for the study (smear-positive [n=1,188] and smear-negative culture-positive [n=152]). LPA demonstrated 1,306 (97.5%) valid results with TUB (Mycobacterium tuberculosis) band, 24 (1.8%) NI, three (0.2%) valid results without TUB band, and seven (0.5%) invalid results. Among the NI results, 22 isolates (91.7%) were found to be rifampicin (RIF) resistant and two (8.3%) were RIF sensitive in the pDST. Sequencing revealed that rpoB mutations were noted in all 22 cases with RIF resistance, whereas the remaining two cases had wild-type strains. Of the 22 cases with rpoB mutations, the most frequent mutation was S531W (n=10, 45.5%), followed by S531F (n=6, 27.2%), L530P (n=2, 9.1%), A532V (n=2, 9.1%), and L533P (n=2, 9.1%).

conclusionThe present study showed that the results of the Genotype MTBDRplus assay were NI in a small proportion of isolates. pDST and rpoB sequencing were useful in elucidating the cause and clinical meaning of the NI results.

Indexed as

Drug Susceptibility TestingLine Probe AssayMycobacterium tuberculosis ComplexSequencing

Identifiers

PMID32752603
PMCPMC7515679
OpenAlexW3047260679

What OpenQuestion holds

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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.