Truenat is a chip-based, point-of-care, rapid molecular test for diagnosis of infectious diseases. The technology is based on the Taqman
RTPCR
Reverse transcription polymerase chain reaction (RT-PCR) is a laboratory technique combining reverse transcription of RNA into DNA (in this context called complementary DNA or cDNA) and amplification of specific DNA targets using polymerase cha ...
(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
Goa () is a state on the southwestern coast of India within the Konkan region, geographically separated from the Deccan highlands by the Western Ghats. It is located between the Indian states of Maharashtra to the north and Karnataka to the ...
-based Molbio Diagnostics Private Limited.
Truenat for TB
Based on findings from a multi-centre diagnostic accuracy assessment conducted by The
Foundation for Innovative New Diagnostics
The Foundation for Innovative New Diagnostics (FIND) is a global health non-profit based in Geneva, Switzerland. FIND functions as a product development partnership, engaging in active collaboration with over 150 partners to facilitate the develo ...
(FIND), the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level of h ...
(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
The Indian Council of Medical Research (ICMR), the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world.
The ICMR is funded by the Gove ...
(ICMR).
The
Government of Andhra Pradesh
Government of Andhra Pradesh, abbreviated as, GOAP, or, Andhra Government, is the Subnational administrative division, subnational government for the Indian state of Andhra Pradesh. It is an elected government with 175 Member of the Legislative ...
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
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). The test processes oropharyngeal and nasopharyngeal swab specimen and provides results within one hour from sample collection.
Samples are collected in a viral lysis buffer that require very minimal biosafety and biosecurity.
The Lancet
''The Lancet'' is a weekly peer-reviewed general medical journal and one of the oldest of its kind. It is also the world's highest-impact academic journal. It was founded in England in 1823.
The journal publishes original research articles, ...
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."''
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.
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.
[{{Cite web, date=2020-07-03, title=WHO endorses Truenat molecular diagnostic tests for TB, url=https://www.news-medical.net/news/20200703/WHO-endorses-Truenat-molecular-diagnostic-tests-for-TB.aspx, access-date=2020-12-04, website=News-Medical.net, language=en]
References
Medical tests
Medical equipment