Nine Covid-19 kits tested, only two approved because of results, says ICMR
Only two of the nine kits the council tested showed 100% concordance among true positive and negative samples, the testing agency said.
The Indian Council of Medical Research said on Monday that it has approved only two test kits in government and private laboratories for the coronavirus, as only those kits that have 100% concordance among true positive and negative samples are being permitted.
The council said it has established a fast-track mechanism for validation of test kits at National Institute of Virology in Pune if they are not yet approved by the United States Food and Drug Administration under its Emergency Use Authorisations. The council said the organisation has completed evaluation of nine such kits, of which only two showed 100% concordance among true positive and negative samples.
The two kits have been manufactured by the companies Altona Diagnostics and MY LAB, Mint reported. The PathoDetect kit 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 six to seven hours.
The total number of Covid-19 cases in India rose to 468 on Monday, and the toll to nine. The government has fast-tracked the validation process for new testing kits.
“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,” ICMR Director General Dr Balram Bhargava said. “And, it not mandatory that they be approved by US-based Food and Drug Administration, a validation from ICMR-NIV is adequate to give them a go-ahead.”
Earlier in the day, ICMR authorised physicians to use the malaria drug hydroxychloroquine as a potentially preventive measure for asymptomatic people closely working with patients infected with Covid-19. The drug will be only given to asymptomatic healthcare workers who are involved in the treatment of suspected or confirmed patients of Covid-19, and household contacts who are looking after people who tested positive.
As many as 3,54,677 people have so far been infected with Covid-19 globally, and 15,436 have died, according to an estimate by Johns Hopkins University.