Coronavirus : ICMR approves low-cost testing method developed by IIT-Kharagpur
This
new testing method implements a highly reliable & accurate molecular
diagnostic procedure, conducted in an ultra-low-cost portable device unit &
costs only around Rs. 500 per test
Biswabrata Goswami
Hummingbird News
KHARAGPUR, 21 October: IIT
Kharagpur researchers have developed a diagnostic machine named ‘COVIRAP,’
the diagnostic machine, which has been successfully validated for its efficacy
in COVID-19 detection by the Indian Council of Medical Research (ICMR).
Various commercial units have already
approached the Institute for technology licensing to enable a rapid reach of
this innovation to the common people.
This test has been designed to be
fairly easy to conduct and affordable as well and can produce results in a
custom-developed mobile phone application within one hour.
It
has an automated pre-programmable temperature control unit, a special detection
unit on genomic analysis, and a customised smartphone app for results.
Three
master mixes work as markers of different genes to confirm the presence of
SARS-CoV-2, said Prof Suman Chakraborty, Dean, Sponsored Research and
Industrial Consultancy, IIT Kharagpur. Samples collected react with these
mixes. When paper strips are dipped into these reaction products, coloured
lines indicate the presence of the virus.
Dr
Arindam Mondal, Assistant Professor, School of Bioscience, IIT-KGP, said the
technology has been subjected to rigorous testing protocols as per ICMR
guidelines.
Addressing a Virtual Press Conference
on 21 October, to announce this major development in the nation’s
fight against COVID-19, Dr. Ramesh Pokhriyal Nishank, Minister of Education,
Government of India, said, “I am glad the researchers from IIT Kharagpur have
achieved the goal of Atmanirbhar Bharat through this medical technology
innovation. This would go on impacting the lives of many in rural India as the
device is portable and can be operated on a very low energy supply. Minimally
trained rural youth can operate this device.”
Further, Dr. Ramesh Pokhriyal
Nishank, said, “This innovation has made high-quality and accurate COVID
testing affordable for the common people with a testing cost of around ₹ 500/- which can further be reduced through government
intervention. As informed by IIT Kharagpur, this machine can be developed at a
cost of less than ₹ 10,000/- with minimal
infrastructural requirement making the technology affordable to common people.
The testing process in this new machine is completed within one hour. I
congratulate Prof. V.K. Tewari, Director, IIT Kharagpur, and the research team
led by Prof. Suman Chakraborty and Dr. Arindam Mondal for this path-breaking
innovation taking molecular diagnostics from high-end labs to the field.”
Speaking about this test, Prof. V.K.
Tewari, Director, IIT Kharagpur, said, “This is indeed one of the greatest
contributions in the history of medical science, particularly in the area of
virology, and is well set to replace PCR-based tests to a large extent.”
Subsequent financial support to this
project was provided by the IIT Foundation, USA, to meet the various expenses
in the clinical testing phase. Partial financial support has also been provided
from the Common Research and Technology Development Hub on Affordable
Healthcare, established by Council of Scientific and Industrial Research
(CSIR), Government of India, at IIT Kharagpur.
Elaborating on the validation process
of ‘COVIRAP’ Diagnostic Test, Dr. Mamta Chawla Sarkar, an Internationally
acclaimed virologist who oversaw the patient trials on behalf of ICMR-National
Institute of Cholera and Enteric Diseases (NICED) said, “A detailed scrutiny of the testing results has clearly shown that
this assay holds the capability of detecting extremely low levels of viral
loads that any other method based on similar principles of testing, even those
from the most celebrated research groups across the world, could not come up
with so far. In practice, this means that very early stages of infection can be
detected, thereby isolating the patient and arresting the uncontrolled spread
of infection in the community via asymptomatic patients.”
Further, Dr. Shanta Dutta, Director
of ICMR-NICED added, “While overseeing the testing and validation, I was very
impressed with the portable low-cost machine unit that can truly be a
game-changer for COVID-19 diagnostics at peripheral laboratories with the
support of unskilled human resources as operators. This now needs a rapid
commercial scale-up to cater to the needs of the underserved population. ICMR-NICED will be pleased to facilitate
support for further improvisations in the method towards even superior
performance.”
The novel diagnostic platform,
developed by a team of researchers lead by Prof. Suman Chakraborty, Professor,
Department of Mechanical Engineering, IIT Kharagpur, and Dr. Arindam Mondal, Assistant
Professor, School of Bio-Science, IIT Kharagpur, has been subjected to rigorous
testing protocols as per ICMR guidelines, at ICMR-NICED, an Institute
authorized by ICMR. The tests conducted there have revealed that the results
from this new assay are of standards comparable to the celebrated RT-PCR tests,
with a remarkably high level of specificity and sensitivity, the two common parameters
used as indicators of efficacy of any diagnostic test.
ICMR-NICED has further certified the
test to be extremely user-friendly. Notably, the number of tests per one-hour
batch in a single machine unit can be further increased to much higher limits,
for the purpose of testing on a mass scale.
Elaborating on this test, Prof. Suman
Chakraborty, Professor, Department of Mechanical Engineering Department, IIT
Kharagpur, said, “The patented machine unit has not only been proven to be
robust during patient sample testing but also extremely flexible and generic.
This means that other than COVID-19 testing, many other tests, falling under
the category of ‘isothermal nucleic acid-based tests’ (INAT), can be performed
in the same machine. In other words, influenza, malaria, dengue, Japanese
encephalitis, tuberculosis and many other infectious, as well as vector-borne
diseases, can be tested using the same machine. This will virtually minimize
the need for thermal cyclers or real-time PCR machines, without sacrificing the
expected high standards of a molecular diagnostic test.”
Further, Dr. Arindam Mondal,
Assistant Professor, School of Biosciences, IIT Kharagpur, said, “During the testing phase of patient
samples, all kits, exclusively developed at IIT Kharagpur, were transported in
an uncontrolled environment for hours to the testing unit, which shows high
levels of stability of the reagents that are being used for the testing.”
Speaking about the commercialization
of ‘COVIRAP,’ Prof. V.K. Tewari, Director, IIT Kharagpur, said, “While the Institute can produce the
testing kit up to a certain scale, patent licensing will facilitate
commercialization opportunities for medical technology companies. Any corporate
or start-up can approach the Institute for technology licensing and commercial
scale of production. The Institute is open to tie-ups, with due measures of
protecting the interest of public health amidst the pandemic situation.”
“Today, it is COVID-19; yesterday, it
was leprosy and tuberculosis; tomorrow, it will be something else. This
technology is all set to create a revolution in rapid and low-cost detection of
all these, by bringing high-end molecular diagnostics from the lab to the
field. The impact of this, therefore, is long-lasting, empowered by the
capability of detecting unforeseen pandemics in the coming years that may
potentially endanger human lives time and again,” remarked Prof. Suman Chakraborty.
