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Centre advises rapid testing for entire populations in Covid-19 hotspots

Maitri Porecha New Delhi | Updated on April 03, 2020

But shortage of kits amid regulatory confusion may prove a hurdle for States

As Covid-19 cases rise sharply across the country, the Centre has said that entire populations in hotspot areas can be tested using rapid antibody tests. These are tests which can be run on blood, plasma or serum samples, are used to ascertain in less than 30 minutes if a person, even if asymptomatic, is Covid-19 positive.

The test usually comes positive if the person on whom it is being run has been infected with the SARS-COV2 virus, which leads to Covid-19 in 7-10 days. The test remains positive for several weeks after the infection, Indian Council Medical Research (ICMR) officials have stated.

Top hotspots

The Centre has identified 25 districts with high case loads, including Mumbai, Kasargod, Hyderabad, Kannur, Pune, Gautam Buddh Nagar (Uttar Pradesh) and Bengaluru, which are the top seven cities, with more than 30 cases each. As on March 31, Mumbai had 142 cases while Kasargod had 107 cases, an internal report on hotspots compiled by the Ministry of Health and Family Welfare stated. In addition to these, three districts each in Gujarat and Kerala and two in Punjab are seen as emerging hotspots.

In its interim advisory of April 2, the ICMR said those who are antibody positive in rapid testing should be further tested and confirmed through the real time polymerase chain reaction (RT-PCR) test, which is conducted by collecting nasal and throat swabs. Those who are negative in the rapid test should still be quarantined at home, because they are in Covid-19 hotspots anyway and may be susceptible to contracting the infection. “Negative test does not rule out Covid-19 infection,” the ICMR advisory said.

Looking for guidance

Even as the ICMR released the interim advisory and an emergency meeting of the National Task Force to finalise the recommendations was held on Thursday, distributors of antibody kits complained that while States were willing to buy the kits, they were waiting to receive guidance from the ICMR on how to proceed.

An Indian distributor of a Chinese company supplying these kits that have already been approved by European regulator CE-IVD, on basis of anonymity, told Businessline: “We have orders now from at least two States who need 2.5 lakh kits in total, but have stated that first we will have to run those kits for validation through ICMR.”

For instance, Bihar, Jharkhand and Assam have been demanding that even CE-IVD kits be first sent to the ICMR for validation.

ICMR’s clarification

However, the ICMR, in its advisory, clarified that CE-IVD-approved kits can be used directly after due approval from the Drug Controller General of India (DCGI) and intimation to the ICMR. The DCGI has not yet made public the list of diagnostic companies and the companies that supply test kits — be it domestic or international — to whom it has granted approval for starting supply in India.

On March 28, the ICMR had released a list of 12 CE-IVD-approved antibody-based rapid kits manufactured in the US, China, Singapore, Poland and India. It also named a Chinese company called Wondfo, whose technology is not CE-IVD-approved but has been validated by the ICMR.

As far as the lab-based RT-PCR tests go, the ICMR, on Thursday, said that it had completed evaluating 20 non-US-FDA or CE-IVD-approved technologies. It also approved kits from five companies — Kilpest (38 Blackbio), SD Biosensor, Seegene, Mylab and Altona Diagnostics. Labs, be they public or private, can only procure kits from these companies or any other kits which are approved by US/European regulators after due approval from the DCGI and intimation to ICMR, it said.

Published on April 03, 2020

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