Evidence map›Paper›PMID 33707390›Full record

ArticleThe Indian journal of medical research2020

Validation of an indigenous assay for rapid molecular detection of rifampicin resistance in presumptive multidrug-resistant pulmonary tuberculosis patients.

N S Gomathi, Manjula Singh, V P Myneedu, D S Chauhan, Srikanth Tripathy, Rohit Sarin, Anant Mohan, Anuj Bhatnagar, Jiten Singh Khangembam, T Kannan and 6 more

Open access · diamondAbstract read
In one paragraph

Article in The Indian journal of medical research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 47% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  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

16 authors at 9 institutions in 5 countries.

N S GomathiDepartment of Bacteriology, Epidemiology Unit, Chennai, Tamil Nadu, India.
Manjula SinghDivision of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
V P MyneeduDepartment of Microbiology, National Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India.
D S ChauhanDepartment of Microbiology & Molecular Biology, ICMR-National JALMA Institute for Leprosy & Other Mycobacterial Diseases, Agra, Uttar Pradesh, India.
Srikanth TripathyICMR-National Institute of Research in Tuberculosis, Chennai, Tamil Nadu, India.
Rohit SarinNational Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India.
Anant MohanDepartment of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India.
Anuj BhatnagarDepartment of Chest & TB, Rajan Babu Institute of Pulmonary Medicine and Tuberculosis, New Delhi, India.
Jiten Singh KhangembamICMR-National Institute of Medical Statistics, New Delhi, India.
T KannanStatistics Section, Epidemiology Unit, ICMR-National Institute of Research in Tuberculosis, Chennai, Tamil Nadu, India.
M V V RaoICMR-National Institute of Medical Statistics, New Delhi, India.
Jyoti LoganiDepartment of Biotechnology, Ministry of Science & Technology, New Delhi, India.
Bindu DeyDepartment of Biotechnology, Ministry of Science & Technology, New Delhi, India.
R R GangakhedkarDivision of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
Soumya SwaminathanWorld Health Organization, Geneva, Switzerland.
Urvashi B SinghDepartment of Microbiology, All India Institute of Medical Sciences, New Delhi, India.
LRS Institute of Tuberculosis and Respiratory Diseases · INNational Institute of Medical Statistics · INDepartment of Biotechnology · INIndian Council of Medical Research · INCzech Academy of Sciences, Institute of Microbiology · CZNational Institute of Epidemiology · INNational Institute of Research in Tuberculosis · INWorld Health Organization · CHWorld Health Organization - Pakistan · PK

Funding

World Health Organization 001
6 · The paper itself

Abstract

BACKGROUND &

objectivesThere is a need for an affordable, easy, high-sensitivity test usable at the peripheral health facility for diagnosis of drug-resistant (DR) tuberculosis (TB) to interrupt disease transmission. Nucleic acid amplification tests (NAATs) for early detection of DR-TB are ideal to bring testing near to the patient. Truenat

methodsConsecutive patients aged 18-65 yr, with symptoms suggestive of TB and with a history of previous treatment, reporting to the National TB Elimination Programme (NTEP) clinics under four national institutes, namely AIIMS (All India Institute of Medical Sciences, New Delhi), NITRD (National Institute of Tuberculosis and Respiratory Diseases, New Delhi), NIRT (National Institute for Research in Tuberculosis, Chennai) and ICMR-National JALMA Institute for Leprosy and other Mycobacterial Diseases, Agra, were included in the study. Two sputum samples (one spot and one morning) were collected from each patient, after obtaining informed written consent. The samples were subjected to smear, GeneXpert and MGIT 960 culture (and drug susceptibility testing to RIF) (surrogate for MDR-TB) to serve as reference tests. The samples were coded to ensure blinding and subjected to Truenat MTB-RIF. Truenat MTB-RIF Version 1.5 was used for testing 1084 samples for RIF resistance, while Version 2.0 was used to test another 1201 samples.

resultsTruenat MTB-RIF Version 1.5 in comparison with comprehensive laboratory reference standards yielded sensitivity and specificity of 76.2 and 94.7 per cent, respectively for the detection of RIF resistance in 1084 samples, collected across four sites. Based on the analysis of discordant samples, Version 2.0 of Truenat was developed by the manufacturer and this was further tested on additional 1201 samples, yielding a sensitivity of 87.5 per cent and specificity of 99.5 per cent. INTERPRETATION &

conclusionsMulticentric trial of Truenat

Indexed as

Mycobacterium tuberculosisTuberculosis, Multidrug-ResistantTuberculosis, PulmonaryAdolescentAdultAgedHumansIndiaMicrobial Sensitivity TestsMiddle AgedRifampinSensitivity and SpecificitySputumYoung AdultRifampinDrug resistantearly diagnosisnucleic acid amplification testsTruenat MTB-RIFtuberculosis

Identifiers

PMID33707390
PMCPMC8157890
OpenAlexW3133587317

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.