Truenat

Truenat is a chip-based, point-of-care, rapid molecular test for diagnosis of infectious diseases. The technology is based on the Taqman RTPCR (Real Time Reverse Transcription Polymerase Chain Reaction) chemistry which can be performed on the portable, battery operated Truelab Real Time micro PCR platform. Truenat is developed and manufactured by Goa-based Molbio Diagnostics Private Limited.[1][2][3][4]

Truenat for TB

Based on findings from a multi-centre diagnostic accuracy assessment conducted by The Foundation for Innovative New Diagnostics (FIND), the World Health Organization (WHO) announced endorsement of Molbio's molecular assays Truenat MTB, Truenat MTB Plus and Truenat MTB RIFDx as initial diagnostic tests of pulmonary Tuberculosis and Rifampicin Resistance through a rapid communication in January,2020. The Truenat test was incorporated in India's National Tuberculosis Elimination Programme after recommendations from the Indian Council of Medical Research (ICMR).[5][6][7][8]

The Government of Andhra Pradesh was one of the first adopter of Truenat under its Revised National Tuberculosis Control Programme (RNTCP) for TB diagnosis. In October 2018, the state rolled out Truenat in Designated Microscopy Centres (DMC) across 13 districts. Truenat was found to improved TB case notification rates by 30% in Andhra Pradesh [9]

Truenat for COVID-19

In April, 2020 the point-of-care Truenat test for diagnosis of COVID-19 was launched after validation at the State Level Virus Research and Diagnostic Laboratory, Bangalore Medical College and Research Institute and subsequent approval from the Indian Council of Medical Research (ICMR).[10] The test processes oropharyngeal and nasopharyngeal swab specimen and provides results within one hour from sample collection. [11]

Samples are collected in a viral lysis buffer that require very minimal biosafety and biosecurity. [12] The Lancet remarked, "This innovative technology-driven COVID-19 testing platform has been a game changer for testing in underserved areas and quick testing in emergency departments of health-care facilities in India."[12]

Technology

The Truenat test is run on the battery-powered Truelab system. This system consists of a sample preparation device ( this device is used for RNA/DNA extraction and then the purification from the sample) and along with that - the PCR analyzer device. This device is available in 1-, 2-, or 4-module configurations. The lattermost configuration is capable of testing four samples at the same time.[13]

The devices function in a wide range of environmental conditions with minimal user input, making them suitable for use in primary healthcare settings with minimal infrastructural requirements, providing an automated reporting system and having real time data transfer capability for centralized monitoring and analytics for disease surveillance.[14]

References
  1. Shankar, Sathyanarayanmuthur; Basawarajappa, Shantalagowdara; Rangaiah, Ambica; Padukone, Shashiraja; Yadav, Pragyad; Gupta, Nivedita (2021). "Performance evaluation of Truenat™ Beta CoV & Truenat™ SARS-CoV-2 point-of-care assays for coronavirus disease 2019". Indian J Med Res. 153 (1 & 2): 144–150. doi:10.4103/ijmr.IJMR_2363_20. PMC 8184085. PMID 33818471.
  2. Basu, Mohana (2020-06-27). "RT-PCR, antigen, antibody, TrueNAT — all you need to know about the different Covid tests". ThePrint. Retrieved 2020-12-02.
  3. "New coronavirus testing kit gives results in just an hour". Deccan Herald. 2020-04-06. Retrieved 2020-12-02.
  4. "COVID-19 testing: How antibody, antigen, RT-PCR, TrueNat tests differ, their strengths and limitations - Health News , Firstpost". Firstpost. 2020-07-09. Retrieved 2020-12-02.
  5. "WHO endorses Truenat molecular diagnostic tests for TB". News-Medical.net. 2020-07-03. Retrieved 2020-12-02.
  6. "World Health Organization endorses Truenat tests for initial diagnosis of tuberculosis and detection of rifampicin resistance". FIND. Retrieved 2020-12-02.
  7. Perappadan, Bindu Shajan (2020-07-03). "WHO nod for Truenat rapid molecular assays for TB". The Hindu. ISSN 0971-751X. Retrieved 2020-12-02.
  8. Ravindranath, Prasad (2020-01-17). "India's TB control programme renamed to reflect its intent on ending TB". Science Chronicle. Retrieved 2020-12-02.
  9. Jeyashree, K.; Shanmugasundaram, D.; Rade, K.; Gangakhedkar, R. R.; Murhekar, M. V. (2020-09-21). "Impact and operational feasibility of TrueNat™ MTB/Rif under India's RNTCP". Public Health Action. 10 (3): 87–91. doi:10.5588/pha.20.0004. ISSN 2220-8372. PMC 7577004. PMID 33134121.
  10. "ICMR validates indigenous assays for COVID-19 diagnosis".
  11. "Covid-19 testing: What are the tests and testing procedures being carried out in India?". The Indian Express. 2020-07-28. Retrieved 2020-12-04.
  12. Gupta, Nivedita; Rana, Salaj; Singh, Harpreet (2020-11-01). "Innovative point-of-care molecular diagnostic test for COVID-19 in India". The Lancet Microbe. 1 (7): e277. doi:10.1016/S2666-5247(20)30164-6. ISSN 2666-5247. PMC 7833111. PMID 33521725.
  13. Lee, David J.; Kumarasamy, Nagalingeswaran; Resch, Stephen C.; Sivaramakrishnan, Gomathi N.; Mayer, Kenneth H.; Tripathy, Srikanth; Paltiel, A. David; Freedberg, Kenneth A.; Reddy, Krishna P. (2019-07-02). "Rapid, point-of-care diagnosis of tuberculosis with novel Truenat assay: Cost-effectiveness analysis for India's public sector". PLOS ONE. 14 (7): e0218890. Bibcode:2019PLoSO..1418890L. doi:10.1371/journal.pone.0218890. ISSN 1932-6203. PMC 6605662. PMID 31265470.
  14. "WHO endorses Truenat molecular diagnostic tests for TB". News-Medical.net. 2020-07-03. Retrieved 2020-12-04.
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