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ORIGINAL ARTICLE
Year : 2020  |  Volume : 152  |  Issue : 4  |  Page : 378-385

Multicentric validation of indigenous molecular test Truenat™ MTB for detection of Mycobacterium tuberculosis in sputum samples from presumptive pulmonary tuberculosis patients in comparison with reference standards


1 Department of Bacteriology, ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India
2 Division of Epidemiology & Communicable Diseases, Indian Council of Medical Research, New Delhi, India
3 Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India
4 Department of Microbiology, National Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India
5 Department of Microbiology & Molecular Biology, ICMR-National JALMA Institute of Leprosy & Other Mycobacterial Diseases, Agra, Uttar Pradesh, India
6 National Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India
7 Department of Pulmonary Medicine & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India
8 Department of Chest & TB, National Institute of Tuberculosis & Other Respiratory Diseases, New Delhi, India
9 Statistics Section, Epidemiology Unit, ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India
10 ICMR-National Institute of Medical Statistics, New Delhi, India
11 Department of Biotechnology, Ministry of Science & Technology, Government of India, New Delhi, India
12 World Health Organization, Geneva, Switzerland
13 ICMR-National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India

Correspondence Address:
Srikanth Tripathy
ICMR-National Institute for Research in Tuberculosis, Chennai 600 031, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmr.IJMR_2539_19

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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 TRC4 primers. 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.


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