'Aiming for 1 million testing kits per day'

A health worker collects a swab sample for the COVID-19 Real-Time Polymerase Chain Reaction (RT-PCR) test. Pic/AFP

Over 11.54 lakh COVID-19 tests were conducted in a span of 24 hours last Wednesday across the country, taking India's cumulative tests to over 5.18 crore. An expanded diagnostic lab network and facilitation for easy testing across the country through various calibrated measures have given the effort a substantial boost. Building on this achievement, the Tests Per Million (TPM) have seen a sharp increase to 37,539, the Union Health Ministry had stated. As the government is now focusing on doubling testing capacity, a new diagnostic project called Indigenisation of Diagnostics (InDx) has been launched.

Anchored at Bengaluru's Centre for Cellular and Molecular Platforms (CCAMP), the project aims to indigenously manufacture, in bulk quantities and at much lower costs, all reagents needed for RT-PCR-based and other molecular methods of diagnostics of COVID-19. Dr Taslimarif Saiyed, CEO of CCAMP, says, "The more we test, the more positive cases are being recorded. Currently, the most reliable diagnostic test is the RT-PCR. A month or two ago, we saw rapid antigen tests being done, too. But it has not still reached good sensitivity or specificity. Therefore, we are trying to develop components required for RT-PCR test kits."

What exactly are reagents? They're the tip of the testing spear in the fight against the Coronavirus infection. No country was prepared nor did they stockpile, thus being vulnerable to reagent shortages. The head of British In Vitro Diagnostics Association, Doris-Ann Williams, said that "there's never been a shortage of chemical reagents before now." In the face of this pandemic, Williams told The New York Times, "all the major countries in the world are wanting the same thing at the same time."

Dr Taslimarif Saiyed

Most countries don't stockpile reagents despite viral epidemics like SARS (2003), MERS (2012, 2015, 2018), Ebola (2014-16, 2019) and Zika (2015-16). "Until now, India was relying on international kits. India no longer wants to be import-dependent in terms of its diagnostic needs. This project will not just double our testing capacity, but also improve the country's healthcare system," Saiyed adds.

US-based The Rockefeller Foundation has provided financial support for the project. It aims to build a supply-chain network of Indian MSMEs capable of producing reagents that go into testing kits, as well as manufacturing the kits. The project involves identifying bottlenecks in the supply-chain network, and gaps in the ability of these MSMEs to scale-up.

"We realised we had a shortage of reagents in March. After acquiring permission from the ICMR, we have now started to make them in India. There are developers, but they are facing technical bottlenecks that are coming in the way of scaling up."

As of now, RT-PCR tests are being done only on a few patients due to reagent shortages. "In the West, people are getting tests done every week before going to work to ensure they won't spread the virus if infected. Multiple and frequent testing is being done regardless of the history of the individual. For that to happen, we need to scale up massively. India's 1.3 billion people should be able to get the RT-PCR test done without having to wait for months. Our aim is to put together a million kits a day."

Saiyed hopes the kits will be ready in a couple of months, hopefully around the same time that a vaccine arrives.

11.54 lakh
No. of COVID-19 tests done in 24 hours in India last week

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