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Home / News / India /  Coronavirus: Govt fast-tracks validation of new testing kits, 2 ready for supply

NEW DELHI: The government has fast-tracked the validation process for new testing kits for Covid-19 and granted approval to new commercial testing kits as total cases surged past 400 across the country.

While, US Food and Drug Administration (FDA) and EUA-CE (European) approved kits can be used directly after due approval from the Drug Controller General of India (DCGI) and intimation to the Indian Council of Medical Research (ICMR).

Those yet to be approved can be tested and validated by ICMR-National Institute of Virology (NIV), Pune.

ICMR Director General, Dr Balram Bhargava said the government has welcomed the use of indigenous diagnostic kits for Covid-19.

“A fast track mechanism has been set up for their validation at NIV, so that tests can be done quickly and we can confirm infections among people. And, it not mandatory that they be approved by US-based Food and Drug Administration (FDA), a validation from ICMR-NIV is adequate to give them a go-ahead," Bhargava said on Monday.

The ICMR has so far completed evaluation of nine testing kits which include one from the Indian Institute of Technology (IIT), Delhi. Of the nine, two RT-PCR kits from Germany-based Altona Diagnostics and Maharashtra-based MY LAB have been approved for use by ICMR-recommended government and private laboratories.

The PathoDetect developed by MY LAB can screen up to 24 samples in a single run and provide results within two hours, while tests currently being used provide results for 90 samples in 6-7 hours.

A real time RT-Polymerase Chain Reaction (PCR) is largely being used to test the presence of SARS-CoV2 in the upper and lower respiratory tract samples of suspected cases.

While different countries have ramped up their testing capacity with new kits which take comparatively lesser time to show results, India has been using RT-PCR probes for diagnosis of Covid-19 which were procured from US by ICMR and NIV, Pune and distributed to the testing laboratories across the country.

Apart from government laboratories, as many as 12 private laboratories with 15,000 collection centres have also been permitted to conduct testing.

Some assays may detect only the novel virus and some may also detect other strains of the SARS-CoV that are genetically similar. Some countries like South Korea have also been using Artificial Intelligence-enabled systems to power their testing capacity.

Globally, over 15,308 people have died due to COVID-19, while the number of those infected crossed 349,211, according to latest data by Johns Hopkins University. In India, the number of cases stand at 425.

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