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Change in ICMR rules stalls COVID-19 test kits from government labs

The Indian Council of Medical Reserach (ICMR) in New Delhi. File

The Indian Council of Medical Reserach (ICMR) in New Delhi. File   | Photo Credit: V. V. KRISHNAN

Rapid rise in COVID-19 cases have forced States to adopt faster tests

COVID-19 testing kits developed by labs of the Department of Science and Technology (DST) and the Council of Scientific and Industrial Research (CSIR) are yet to make it to the market thanks to a change in rules by the ICMR that now requires additional data and not just results from laboratory-controlled conditions from research labs.

With nearly 4,50,000 positive cases nationally, several States have adopted testing strategies beyond the standard-of-diagnosis RT-PCR kits. The Delhi government last week allowed the use of a rapid antigen test that is cheaper and gives quicker results but is less reliable when there is limited background prevalence of the disease.

Multiple tests

The ICMR recommends the kit developed by SD Biosensor, a South Korean company, but manufactured in India, as a confirmatory for positive test but a requires a re-test with PCR if the person tests negative.

There are also rapid antibody tests that can detect antibodies, or exposure to the virus, but are not useful in confirming an active infection.

Also read: ICMR to get 10 lakh RT-PCR testing kits

On May 5, the CSIR-Institute of Genomics and Integrative Biology (IGIB) announced a collaboration with Tata Sons Ltd to develop a paper-based test, called FELUDA, that could detect the presence of the virus. Unlike the conventional RT PCR test that requires a specialised machine, FELUDA (FNCas-9 Editor Linked Uniform Detection Assay), was relatively more adaptable and could be used in conventional pathology labs that didn’t have a PCR machine. Moreover the results, its developers say, would be available in one hour.

Early results

However, officials said approvals for FELUDA would take more time. The FELUDA kit, which uses a CRISPR-cas9 gene editing system to detect the coronavirus, was developed completely in-house and based on the results, Tata Sons decided to take it up for production. In March and April, when ICMR was approving home grown kits, it only needed a single batch of test kits to pass muster. Plus it was acceptable to supply kits made in a research laboratory, where usually pristine conditions prevail.

Also read: COVID-19 test kits should be made available at lowest cost: Delhi HC

Following the change in the ICMR’s rules, Dr. Anurag Agrawal, Director, CSIR-IGIB said, “Now at least three batches have to be made and, by the company, in their facilities.”

Following the earlier nod, Dr Agrawal said, “Tata Sons got a factory in place in Chennai but due to the lockdown there were delays in readying it as well as in procuring some of the equipment needed for the test.”

Another testing kit announced in April by the Sri Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMS), Thiruvananthapuram, that was initially approved by the Pune-based ICMR-National Institute of Virology (NIV) sister-lab in Alapuzha, and commercially developed along with Ernakulam-based Agappe Technologies, is nowhere near ready.

Also read: CSIR to let firms defer fee on use of its technology

The kit employs a technology called LAMP (Loop Mediated Isothermal Amplification) that was billed as a faster way to detect the virus but - being an emerging technology - required different chemicals and a new kind of machine to work. Asha Kishore, Director, SCTIMS, said the company was now changing tack.

“The company hasn’t reapplied for ICMR approval. They are changing the machine towards a more PCR-like application. We are working on a totally new format.”

The ICMR’s early experience with rapid antibody tests, where it had procured several kits from Chinese companies and farmed it to states, that then reported incorrect prevalence, has forced it to go slow on kit approvals. While the ICMR periodically approves kit manufacturers, most of them are companies that have licensed foreign technology.

More recently, a kit developed by the Indian Institute of Technology Delhi was approved on the June 19, again among the very few developed entirely in-house.

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Printable version | Jul 11, 2020 9:41:55 AM | https://www.thehindu.com/news/national/change-in-icmr-rules-stalls-covid-19-test-kits-from-government-labs/article31900038.ece

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