ICMR fast-tracks validation of commercial testing kits
The Indian Council of Medical Research (ICMR) has added three more labs to evaluate commercial kits to test for coronavirus disease (Covid-19), taking the total number of such facilities clearing the devices to four, including the National Institute of Virology (NIV) in Pune.
Apart from the apex virology laboratory, ICMR has identified three more of its laboratories from national institutes to conduct evaluation of commercial testing kits for use in Covid-19 testing across India.
“Testing of kits is being fast-tracked by ICMR as ICMR-certified testing kits can also be used for testing,” said Dr Balram Bhargava, director-general, ICMR.
The three newly identified laboratories of ICMR are: the National AIDS Research Institute (NARI) in Pune, the National Institute of Pathology in New Delhi, and the National Institute of Cholera and Enteric Diseases (NICED) in Kolkata.
ICMR had initially allowed only the use of United States Food and Drug Administration (US FDA) and European Union certification (EUA/CE) approved testing kits for in-vitro diagnostics (IVD), meaning tests done on samples such as blood or tissue that have been taken from the human body to detect diseases or other conditions for Covid-19 testing
The use of these kits was made mandatory for the private labs to test for Covid-19. As the numbers started to rise, the research council last week also allowed use of testing kits validated by NIV.
Apart from the 118 government laboratories that are approved to test for Covid-19, the government has allowed 29 private labs across India.
From the start of the outbreak in India, the NIV had been approached by various commercial testing kits manufacturers for validation, and had begun the process of evaluation some time in February. Three commercial assays (testing kits) have been approved by the NIV, including one from an Indian manufacturer.
Pune-based molecular diagnostics company, Mylab Discovery Solutions Pvt Ltd, that developed first Made in India Covid-19 testing kit has announced that it is ready with the first batch of test kits and will start supplying to the government and private labs.
In the first batch, it will supply testing kits to conduct 15,000 tests, and can ramp up capacity from 20,000 to 50,000 kits a day. ICMR has identified seven locations for storage of testing kits as it has procured one million kits from Germany and is expecting one million more kits from the World Health Organisation to strengthen its testing capacity.
As researchers suggest blood tests as a strategy to combat Covid-19 outbreak as the results are quicker and the presence of antibodies against the virus in the bloodstream can also suggest past infection, the ICMR is also looking at including blood tests, and has also asked for quotations from manufacturers of antibody based test kits.
The ICMR has estimated the tentative requirement of 10,00,000 tests kits.
India so far has tested 25,144 samples for Covid-19, and has the capacity of testing 12,000 samples in a day in its government laboratories alone.