IIT-D develops cheaper RT-PCR test, gets ICMR nod
The government has capped the price for an RT-PCR test at private labs at ₹4,500.Updated: Apr 24, 2020 02:08 IST
Researchers at the Indian Institute of Technology (IIT), Delhi, have developed a more economic real time polymerase chain reaction (RT-PCR) test for Covid-19. This will say will reduce the cost of a test by at least ₹700, they said.
The government has capped the price for an RT-PCR test at private labs at ₹4,500.
The Indian Council of Medical Research (ICMR) approved the kit on Thursday, making it the first kit by a research institute to get the approval. So far, RT-PCR kits of at least eight Indian companies have been approved by the ICMR.
It will bring down the cost of the basic assay to ₹400 per test, from around ₹1,100 per assay at present.
This is the first “probe-less” test that has been approved by the apex research body, which will help in not only making the tests cheaper, but also scalable. “All the tests that are currently available in India use a fluorescent probe for the readout from the assay. We have removed that step in our test kit. This does two things — one, the fluorescent probe is an expensive component and two, the manufacturers around the world are currently backed up and it is taking a while to get these, making it difficult to scale up tests,” said Prof Vivekananda Perumal, who heads the team that developed the kit, at Kusuma School of Biological Sciences in IIT Delhi.
The team received the ICMR nod on Thursday evening and plans to apply for an approval from the drug regulator Central Drugs Standard Control Organisation next week.
“A few companies have shown interest and have been in touch with IIT. We will soon choose a manufacturing partner,” said Perumal.
The kit had been submitted for an evaluation to ICMR’s National Institute of Virology in Pune in March, but had not been approved as the specificity was found to be 10%. The sensitivity was found to be 98%.
Now, both the values are at 100%, a requirement for approval by ICMR.
The specificity is the ability of a test to correctly identify those without the disease (or true negatives) and the sensitivity of a test is its ability to correctly identify those with the disease (or true positives).
The team, which was initially working with the DNA sequence of the virus, said the efficiency of the test increased with the use of the viral RNA. The DNA encodes the genetic information in humans and the RNA copy of this genetic information is needed to build different proteins in the body.
Sars-Cov-2, the virus that causes Covid-19, encodes its genetic information in an RNA. The IIT Delhi team identified unique regions (short stretches of RNA sequences) in the Sars-Cov-2 genome, which are not present in other human coronaviruses, to make the test efficient.
“I have not used a test kit without the fluorescent probe, so my confidence in the test is not high. This is not to say that there is anything wrong with the test. I will prefer conventional technology that I am comfortable with instead of trying out a new test at this time, even if it is cheaper,” said Dr Navin Dang, founder, Dr Dang’s Lab.