Evidence map›Paper›PMID 33380702›Full record

ArticleThe Indian journal of medical research2020

Multicentric validation of indigenous molecular test Truenat™ MTB for detection of

N S Gomathi, Manjula Singh, Urvashi B Singh, V P Myneedu, D S Chauhan, 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 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
0.3field-weighted citation impact, top 29% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Diagnostic yield of Xpert MTB/RIF, Xpert MTB/RIF Ultra, and Truenat MTB assays on non-pulmonary samples from suspected cases of extra-pulmonary tuberculosis (EPTB).European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology · 2025
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  11. Establishing proof of concept for utility of TrueprepThe international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease · 2023
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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 10 institutions in 3 countries.

N S GomathiDepartment of Bacteriology, ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
Manjula SinghDivision of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
Urvashi B SinghDepartment of Microbiology, All India Institute of Medical Sciences, 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 of Leprosy & Other Mycobacterial Diseases, Agra, Uttar Pradesh, 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, National Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India.
Jiten Singh KhangembamDepartment of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India.
T KannanStatistics Section, Epidemiology Unit, ICMR-National Institute for 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, Government of India, New Delhi, India.
Bindu DeyDepartment of Biotechnology, Ministry of Science & Technology, Government of India, New Delhi, India.
Raman R GangakhedkarDivision of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
Soumya SwaminathanWorld Health Organization, Geneva, Switzerland.
Srikanth TripathyICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
All India Institute of Medical Sciences · INIndian Council of Medical Research · INNational Institute of Research in Tuberculosis · INGovernment of India · INLRS Institute of Tuberculosis and Respiratory Diseases · INMinistry of Science and Technology · INMRC Epidemiology Unit · GBNational Institute of Medical Statistics · INNational JALMA Institute for Leprosy & Other Mycobacterial Diseases · INWorld Health Organization · CH

Funding

World Health Organization 001
6 · The paper itself

Abstract

BACKGROUND &

objectives: Early case detection is essential to interrupt transmission and to prevent further spread of tuberculosis (TB) in high endemic settings. Nucleic acid amplification tests (NAATs) with visual read-outs are ideal as point-of-care tests. Truenat™ MTB is an indigenous chip-based NAAT for detection of Mycobacterium tuberculosis, which involves extraction of DNA and real-time polymerase chain reaction (PCR) using portable, automated, battery-operated instruments. The current multicentric study was aimed to evaluate Truenat for detection of MTB in sputum samples obtained from patients with presumptive pulmonary TB with reference to culture as gold standard and Xpert as a comparator.

methods: The study was conducted at four sites, namely ICMR-National Institute for Research in Tuberculosis, Chennai; All India Institute of Medical Sciences, New Delhi; ICMR-National JALMA Institute for Leprosy and Other Mycobacterial Diseases, Agra; and National Institute of TB and Respiratory Diseases, New Delhi. Patients suspected to have TB were screened for eligibility. Two sputum samples were collected from each patient. Tests included smear, Xpert and Truenat directly from the sputum sample and culture by Lowenstein-Jensen (L-J) medium and MGIT960 from decontaminated pellets. Sample used for Truenat assay was coded. Resolution of Truenat false positives was done using an in-house PCR with TRC

results: The study enrolled 2419 presumptive TB patients after screening 2465 patients, and 3541 sputum samples were collected from the enrolled patients. Results of 2623 samples were available for analysis. Truenat showed a positivity rate of 48.5 per cent as compared to 37.0 per cent by Xpert. The sensitivities of Truenat and Xpert were was 88.3 and 79.7 per cent, respectively in comparison with culture. INTERPRETATION &

conclusions: Truenat MTB identified more positives among culture-confirmed samples than Xpert and had higher sensitivity. In addition, other advantageous operational features of Truenat MTB were identified which would be useful in field settings.

Indexed as

Mycobacterium tuberculosisTuberculosis, PulmonaryHumansIndiaReference StandardsSensitivity and SpecificitySputumBattery-operated tuberculosis detection kitmolecular detectionMTBPOC testrapid detection of MTBTruenattuberculosis

Identifiers

PMID33380702
PMCPMC8061602
OpenAlexW3113835798

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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.