PCR Kits approved for testing of Covid-19 as on 26.05.2020

With the recent spread of this COVID-19 pandemic, the availability and facility of testing was a dreadful question. However, in a recent series of events, the GOI approved about 98 firms to supply PCR kits for testing the coronavirus on symptomatic or asymptomatic patients. 

How fast the test is done is one of the important factors in the efficient management of an outbreak. Knowing that the patient has coronavirus implies the health care workers know how to react, the type of treatment should be given, the place where the patient should be kept in the hospital specifically in those communities having dedicated COVID-19 ward.

Today, the most dependable test for detection of coronavirus is testing to confirm the presence of virus RNA.

This is the reason real-time reverse transcription –Polymerase Chain Reaction (RT-PCR) depending tests are mostly recommended for diagnosis of COVID-19. This test detects the presence of the virus RNA in the human samples. It is a process where some copies of DNA are subjected to amplification for production of several millions of copies. Moreover, the test also requires primers, nucleotides, enzyme cofactors, probes and a buffer solution.

Labs across the world are making use of primers and probes for testing the presence of COVID 19 virus.

This is the reason India has also approved the use of PCR kits for speeding the test of Covid-19. The Indian Council of Medical Research(ICMR) has approved 176 labs along with 47 private labs for the conductance of tests. The first test kit that obtains FDA approval is the Cobas SARS CoV-2 kit from Roche, has also got approval in India. Then the second one Taq path COVID 19 combi PCR kit from Thermo Fisher also got validation from ICMR labs. All newly developed and imported kits have to abide by the medical device regulations in India. However, the stringent clauses have been eased at the moment.

Moreover, ICMR has also validated kits from three Indian manufacturers. These agencies will offer the primer and probes along with the master mix to the selected government labs, but it is not clear whether they are exactly the similar probes and primers as per CDC protocol.

As of advisory from ICMR on May 26, the use of FDA approved kits along with the primers and probes is advisable for private labs. When proper certification along with training is in place, all accredited labs can give the required results.