Test kit cos seek Omicron +ve samples

MUMBAI: Amidst the emergence of the latest Omicron variant and a need for accurate screening, diagnostic kit companies are feeling stymied due to the inaccessibility of 'positive samples', which may be required by them to upgrade and validate the strain. The access to 'positive blood samples' is considered important for development, upgradation and testing of Omicron as it is feared that the existing RT-PCR kits may not detect the mutant strain accurately, experts say.

According to WHO, the S gene is not present in the Omicron variant. Existing RT-PCR tests may suggest the presence but not confirm the variant, for which genome sequencing may be further required.

"Industry is waiting for the sample to upgrade and test for the strain. The private sector has never had access to the positive samples of any strain of Covid-19 during the past two years. Niti Aayog permitted only government laboratories/ bodies to have access. Industry was asked to send their developed products to ICMR for evaluation," an industry expert told TOI.

There have been discussions held between the Centre and industry on a policy which could facilitate the sharing of samples for a faster development of indigenous diagnostic kits, as is the established norm in certain developed countries. Real-world samples and viral cultures are required to verify that test kits continually detect new variants. Pune-based National Institute of Virology has already initiated efforts to isolate and culture the Omicron strain derived from a patient sample. There is at least one domestic manufacturer that is ready with the product to be submitted to ICMR for evaluation, the expert noted.

Domestic company Mylab announced that its kits detect coronavirus infection for 12 major variants. "Omicron variant would have no impact on the detection efficacy of our RT-PCR, rapid antigen, and self-testing kits," the company said.