The machine costs less than Rs 5,000 and the test kits would each cost around Rs 500, the IIT-Kharagpur researchers said.
A new coronavirus diagnostic method, using a low-cost portable unit developed by researchers at the Indian Institute of Technology (IIT), Kharagpur, has been approved by the Indian Council for Medical Research (ICMR) after tests with samples of patients will show a level of precision. slightly lower than the gold standard RT-PCR method at a fraction of the cost.
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The machine cost less than 5,000 rupees and the test kits would each cost around 500 rupees, IIT-Kharagpur researchers told reporters on Wednesday. Once the viral RNA was extracted, the testing process took about an hour. The IIT was in talks with commercial manufacturers and startups, and expected the government to subsidize the cost of the test kits as well, they said.
In parallel tests with 200 samples containing a wide range of viral loads, the IIT-Kharagpur COVIRAP method correctly detected 108 of the 115 positive samples identified by an RT-PCR machine, and 83 of the 85 negative samples, which means which has a 94% sensitivity and 98% specificity compared to RT-PCR.
“Initially, we were very skeptical, but we were glad when it worked. The trials are comparable [to RT-PCR]”ICMR virologist Mamta Chawla Sarkar told reporters on Wednesday.
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“This assay has the ability to detect extremely low levels of viral loads than any other method based on similar test principles … In practice, this means that very early stages of infection can be detected, thus isolating the patient and arresting to the uncontrolled spread of infection in the community through asymptomatic patients, ”he noted.
Only ₹ 5,000 to do it
Unlike the RT-PCR machine, which could cost up to ₹ 25 lakh, and needed to be operated by a molecular biologist, the COVIRAP machine cost the IIT researchers only ₹ 5,000 and could be manufactured at an even lower cost if achieved. scale economics. they were applied by commercial manufacturers, said IIT lead researcher and professor Suman Chakraborty.
‘Ideal for use in rural areas’
“The COVIRAP method requires very little equipment and is ideal for use in rural areas with limited facilities. The portable unit can even be placed on a table in a field, without the need for an air-conditioned laboratory. It can be operated by rural youth with minimal training, ”said Dr. Chakraborty. However, the viral RNA would still have to be extracted in a laboratory.
The machine employed an isothermal nucleic acid amplification method, which eliminated the need for a thermal cycler, he said. Once the sample has been processed in the machine after it has been mixed with the solutions developed by the IIT team, treated strips of paper, similar to pregnancy strips, are immersed and the appearance of colored lines will represent the presence of the virus . A mobile application has been developed to analyze the strips placed in a portable unit, in order to minimize human error.
Isothermal nucleic acid amplification employs a similar approach to RT-PCR and has its advantages and disadvantages. Other laboratories, including those of the CSIR (Council for Scientific and Industrial Research) and the Department of Science and Technology, have designed devices based on this approach, but none have been licensed by the ICMR or reached the commercial manufacturing stage.
FELUDE test
FELUDA, a kit developed by CSIR-IGIB (Institute for Genomics and Integrative Biology), is also a ‘paper strip-based test’ but employs a gene editing technology called CRISPR-cas9. Like COVIRAP, it also claims to deliver results in one hour, compared to 3-4 hours in an RT-PCR, but these are ultimately laboratory tests and rely on trained personnel to extract nucleic acid RNA from a sample nasopharynx prior to the actual test. FELUDA, licensed by the Comptroller General of Drugs of India and ICMR, has been licensed to Tata Sons and is expected to be commercially available later this month.
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The COVIRAP method could be used to diagnose diseases such as influenza, malaria, dengue and tuberculosis, said Dr. Chakraborty.
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