The Indian Council of Medical Research (ICMR) has approved a new Chennai-developed RT-PCR kit that can detect and differentiate the Omicron variant from other variants, including Delta, in just 45 minutes. Instead of waiting for genome sequencing analysis to know which type of variant one may be infected with, the KRIVIDA Novus RT-PCR kit detects SARS-CoV-2 using five different gene targets with a variant-specific S gene probe for Omicron.
The kit has been developed in collaboration with ImmuGenix Bioscience.
Dr Naveen Kumar Venkatesan, principal inventor of the kit, chief scientist, founder and director, ImmuGenix Biosciences said in a press statement, “Currently, patients who test positive for Covid-19 have to undergo genome sequencing to know the variant they have been infected with. KRIVIDA Novus kit employs a specific pattern of a unique combination of S Gene Target Failure strategy and ‘Omicron specific amplification signal’ to detect the variant. The kit detects the Omicron variant (B.1.1.529) and all its sub-lineages, such as BA.1, BA.2 and BA.3”.
The kit helps in the identification of SARS-COV-2, Delta, and Omicron in one single test in a short time. The current RT-PCR kit does not provide this information, Dr Venkatesan told indianexpress.com.
Dr Shanmugapriya, head of research and development, Kriya Medical Technologies said that the kit detects four genes of SARS-COV-2 and 1 human gene as an internal control. “This is one of its kind as other available RT-PCR kits detect maximum 3 genes of SARS-COV-2. This increases the specificity of detection. One of the genes is specific for Omicron variant and hence this kit helps in its identification. This helps in understanding the prognosis of the patient at an economical cost and a feasible mode when compared to sequencing,” Dr Shanmugapriya told indianexpress.com.
ICMR has approved yet another RTPCR kit (Source: ICMR.gov.in)
Notably, this is the latest homegrown RT-PCR kit to get approval after Tata MD CHECK RT-PCR OmiSure. The test which comprises a single-tube assay, according to the company, is “compatible with most Real-Time PCR machines with a test run time of 45 minutes, enabling the testing sites to conduct 2,160 tests within 24 hours”.
“It not only tackles the issue of delayed testing, but it also helps in swift prevention of spread. Furthermore, since the test can differentiate between variants, it’s also ideal for entry point screening of travellers at airports,” said Anu Moturi, CEO and Founder, KRIYA Medical Technologies.
How is it used?
The kit can be used in the same way as the current Real-Time RT-PCR, said Dr Venkatesan, where in a sample of nose or throat swab is taken to analyse the genetic fragments of the virus.
What is its cost?
The kit will be priced competitively. Since we want to make it accessible to everyone, it will be more affordable than the other options currently available, Moturi told indianexpress.com.
When will it be available in the market?
It will be available in the market within the next seven days. Airports, governments, labs and any hospital can use our kits, said Moturi.
Till date, 517 RT-PCR kits have been evaluated by ICMR validation centres, according to its website.
The acceptance criteria is a sensitivity of 95 per cent and above, and specificity of 99 per cent and above. At least 95 per cent concordance among positive and at least 90 per cent concordance among negative samples, and with more than 95 per cent samples showing amplification in internal control.
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