NEW DELHI: Expanding the network of laboratories to test suspected Covid-19 cases, the government and its research wing— Indian Council of Medical Research (ICMR) — have so far approved 16 private diagnostic lab chains with over 15,000 collection centres spread across the country and more are in the process of approval, officials said.
Over 60 private laboratories have applied to the ICMR seeking approval. Besides, two companies have also secured approval from the ICMR for locally manufactured testing kits. These kits can be used in designated public and private labs for testing Covid-19 patients. “ICMR has established a fast-track mechanism for validation of non-US FDA EUA/ CE IVD approved kits at ICMR NIV Pune,” ICMR director-general Balram Bhargava said. He added that more locally manufactured kits would soon be approved and may also help bring down the price of testing.
Indian Council of Medical Researchs National Institute of Virology, Pune, has so far evaluated nine non-US FDA and non-EU certified kits. Only test kits with 100% concordance among true positive and true negative samples' have been recommended for commercial use in India. In view of the rising number of cases, the government came out with detailed guidelines last week allowing private diagnostic labs to start testing of suspected Covid-19 cases. As per the norms, any NABL-accredited lab meeting the criteria and having USFDA or EU-approved kits can conduct commercial tests. Such kits can be used directly after due approval from the DCGI and intimation to ICMR. The price for testing was capped at Rs 4,500 even as the government urged the private sector to do tests for Read More – Source
NEW DELHI: Expanding the network of laboratories to test suspected Covid-19 cases, the government and its research wing— Indian Council of Medical Research (ICMR) — have so far approved 16 private diagnostic lab chains with over 15,000 collection centres spread across the country and more are in the process of approval, officials said.
Over 60 private laboratories have applied to the ICMR seeking approval. Besides, two companies have also secured approval from the ICMR for locally manufactured testing kits. These kits can be used in designated public and private labs for testing Covid-19 patients. “ICMR has established a fast-track mechanism for validation of non-US FDA EUA/ CE IVD approved kits at ICMR NIV Pune,” ICMR director-general Balram Bhargava said. He added that more locally manufactured kits would soon be approved and may also help bring down the price of testing.
Indian Council of Medical Researchs National Institute of Virology, Pune, has so far evaluated nine non-US FDA and non-EU certified kits. Only test kits with 100% concordance among true positive and true negative samples' have been recommended for commercial use in India. In view of the rising number of cases, the government came out with detailed guidelines last week allowing private diagnostic labs to start testing of suspected Covid-19 cases. As per the norms, any NABL-accredited lab meeting the criteria and having USFDA or EU-approved kits can conduct commercial tests. Such kits can be used directly after due approval from the DCGI and intimation to ICMR. The price for testing was capped at Rs 4,500 even as the government urged the private sector to do tests for Read More – Source
