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16 private labs with 15,000 centers get approval to test coronavirus infection

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Sushmi Dey    24 March 2020

The government and its research wing— Indian Council of Medical Research (ICMR) have approved 16 private diagnostic lab centers with over 15,000 collection centers across the country to test suspected coronavirus cases. According to officials, there are more in the process of approval.

More than 60 private laboratories have applied to the ICMR for seeking approval. Also, 2 companies have got approval from the ICMR for locally manufactured testing kits. These kits are to be used in selected public and private labs for testing coronavirus patients.

ICMR Director &General Balram Bhargava said that ICMR has established a fast-track procedure for authentication of non-US FDA EUA/ CE IVD approved kits at ICMR NIV Pune. He further said that more locally manufactured kits would be available soon and approved and the price of testing would also be reduced.

ICMR, National Institute of Virology, Pune, has assessed 9 non-US FDA and non-EU certified kits. Test kits with 100% concordance between true positive and true negative samples are recommended for commercial use in India.

Due to the growing number of cases, the government gave detailed guidelines last week permitting private diagnostic labs to start testing suspected coronavirus cases. As per the standards, any NABL-accredited lab meeting the norms and having USFDA or EU-approved kits can conduct commercial tests. Such kits can be used directly after the approval from the DCGI and indication to ICMR. The price for testing was at Rs 4,500 even though the government has insisted the private sector to do tests for free or at subsidized price. According to ICMR’s recent update, on Monday morning, almost 18,383 samples were tested for coronavirus. The health ministry confirmed almost 433 confirmed cases.

Many districts in more than 19 states are under lockdown as the health ministry has advised isolation as a strategy to break the chain of COVID-19 transmission that resulted from the entry of more number of Indian citizens from coronavirus affected countries in the past few weeks.

The health ministry has advised states to implement complete lockdown as partial lockdown will reverse the purpose. The ministry has also asked states to take strict action against those who are violating the law.

Source: ET Healthworld

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