Expansion of tests


 On 17 March, the Union Ministry of Health had decided to allow private pathology labs to test for COVID-19. The ministry official claimed that by allowing private labs, the work of testing can be doubled. The ministry said that National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited laboratories may soon be allowed. Once set up, a person can get COVID-19 test done at a private lab after a qualified physician in a government facility recommends it. The ICMR has appealed to the private labs to offer the tests for free as the government labs do.

On 18 March, a top health ministry official said that a Swiss private company named Roche Diagnostics has been given the Food and Drug Administration (FDA) emergency approval to conduct tests for coronavirus. The Indian regulator has given them a licence to conduct diagnostic tests of the virus on 17 March. The Drug Controller General of India (DCGI) was assessing giving another firm licence while two Indian diagnostic companies have also sought approval for the coronavirus testing kits developed by them. The government has also issued guidelines to cap the cost of sample testing by private labs at ₹4,500.

On 19 March, Ramanan Laxminarayan, director of the Center for Disease Dynamics, Economics & Policy stated that India could be facing a "tsunami of cases within a few weeks" as testing increases and the reason for the low number of confirmed cases currently is due to under-testing. He also said that according to mathematical models applied in the US or UK at least 20%–60% of the population will be affected. Applying the same models in India means that at the lower end of the estimate there could be 300 million cases of which 4–8 million could be severe.

111 additional labs for testing became functional on 21 March. On 24 March, Pune-based molecular diagnostic company Mylab Discovery Solutions became the first Indian company to have received validation for its RT-PCR tests from National Institute of Virology and the Indian Council of Medical Research (ICMR). The test takes 2.5 hours and the company is looking to price it at around ₹1,200 (US$17), or Rs 80,000 for a 100 test kit.

In April, Institute of Genomics and Integrative Biology of Delhi had developed low cost paper-strip test that could detect COVID-19 within an hour. Each test would cost ₹500 (US$7.00) and method could fulfill India's rapid need of testing.

On 13 April, ICMR advised pool testing in the low infection areas with a positivity rate less than 2% to increase the capacity of the testing and save resources. In this process maximum five samples are tested at once and samples are tested individually only if a pool tests positive. Andaman and Nicobar Islands and Uttar Pradesh have started doing pool testing.

On 14 April, ICMR and DGCI approved 18 new suppliers of test kits that included three Indian firms, bringing the total suppliers to 51.

On 16 April, 650,000 Rapid antibody test and RNA extraction kits were dispatched from China, and over 2 million kits were to be sent in next 15 days. On 21 April, Health department of West Bengal alleged that large number of testing kits supplied by ICMR-NICED (National Institute of Cholera and Enteric Diseases) were giving inconclusive results. ICMR-NICED admitted that there was problem in the kits and said that they are addressing the issue. While Rajasthan stopped using rapid testing kits as they were giving low accuracy of 5.4% in compared to expected 90% accuracy. Later, ICMR advised all states to stop using rapid testing kits for next two days until their on-ground teams validates these kits. Rapid antibody test kits were put on hold till further notice. The Chinese manufactures of the rapid testing kits said that the testing kits were approved by ICMR and the problem is not with the kits but with the way they were being used. However, Chinese manufacturers promised to cooperate with Indian authorities to resolve the issue. Amid this, ICMR asked states to return the faulty kits which will be sent back to the Chinese suppliers and cancelled the order of all remaining kits.




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