NEW DELHI: The new reliability figures from the Indian Council of Medical Research (ICMR) suggest that the test developed by the National Institute of Virology (NIV), Pune will provide a much more correct picture of exposure to COVID-19 during natinowide surveillance than the numbers provided by the Union Health Ministry earlier.
A statement by the ICMR said that the igG ELISA antibody test has 98.7 per cent sensitivity and 100 per cent specificity.
Lav Agarwal, Joint Secretary in the Health Ministry in a press briefing on Monday had said that the kit "Covid Kavach ELISA" has 92 per cent sensitivity and 97 per cent specificity—much lower than the figures given by the ICMR.
These reliability figures in a testing kit are extremely crucial and kits with higher specificity and sensitivity can capture the true extent of infection spread unlike those with lower figures that may miss true positives and indicate false negatives.
The Centre has already announced a hospital-based surveillance survey in all 733 districts and household-level survey in 69 districts to assess the level of community transmission of COVID-19 using the newly developed kits.
Based on the Health Ministry's figures earlier, many experts had expressed concern that there could be many cases of false negatives and false positive detected and the surveillance exercise, mainly in areas with high prevalence of COVID-19, may not be credible.
The ICMR announcement, therefore, has come as good news.
On being asked about it, Dr Nivedita Gupta, senior scientist of the ICMR said that these figures had remained the same since the external validation of the kits and validation of first batch of kits produced by Zydus Cadila—with whom the government had first tied up for mass manufacturing of the kits.
When reached for comments, Agarwal said: "I had indicated figures as given by the ICMR and their today’s statement indicates the latest status as they have got an external evaluation done. It's also possible that they might have worked on further improvement (of the kits)."
Meanwhile, the ICMR further clarified that after developing the kits at ICMR-NIV, Pune, based on the potential of companies, had offered four companies—Span, J Mitra, Zydus Cadila and Cipla to take up the production but the three refused to take up the offer.
The Council then signed a non-exclusive agreement with Zydus Cadila and is now in the process of granting the production licenses to two more companies-- Cipla and Nextgen LifeSciences.