After NIV, ICMR Adds Three More Laboratories To Fast-Track Evaluation Of Commercial Testing Kits For Covid-19

In a bid to fast-track the evaluation of commercial test kits for Coronavirus (Covid-19), the Indian Council of Medical Research (ICMR) has increased the number of labs for validating such devices to four, reports Hindustan Times.

The ICMR had initially allowed only the use of testing kits approved by United States Food and Drug Administration (USFDA) and European Union Certification (EUC) for in-vitro diagnosing to detect Covid-19.

The in-vitro diagnostics are tests done on samples such as blood or tissue that have been taken from the human body.

The use of USFDA/EUC approved kits was made mandatory for the private labs to test for the Coronavirus infection. However, due to the surge in the samples for testing, the ICMR last week also allowed the use of testing kits validated by the National Institute of Virology (NIV), Pune.

The ICMR has now increased the number of laboratories by adding three more of its labs to validate the commercial testing kits.

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.

“Testing of kits is being fast-tracked by ICMR as ICMR-certified testing kits can also be used for testing,” Dr Balram Bhargava, director-general, ICMR was quoted as saying.

The tests for the Covid-19 are being done in 118 government laboratories as well as 29 private labs across India.

NIV, which was being approached by various commercial testing kits manufacturers since the outbreak of Covid-19 in India, had begun the process of evaluation in February. It has so far approved three commercial assays (testing kits), including one from an Indian manufacturer.

According to the report, Pune-based molecular diagnostics company, Mylab Discovery Solutions Pvt Ltd, has developed the first made in India Covid-19 testing kit. The company has announced that it is ready with the first batch of the test kits and will start supplying to the government and private labs.

In the first batch, the company will supply testing kits to conduct 15,000 tests, and can ramp up capacity from 20,000 to 50,000 kits a day.

The ICMR has also procured one million kits from Germany and is expecting one million more from the World Health Organisation to strengthen its testing capacity. The council has reportedly identified seven locations for the storage of testing kits.

The ICMR is also looking at including blood tests for diagnosis of Covid-19 and has also asked for quotations from manufacturers of antibody-based test kits.

As per the report, India has so far tested over 25,000 samples for Covid-19 and has the capacity of testing 12,000 samples in a day in the government labs alone.