The ICMR said in a statement that National Institute of Virology (NIV), Pune, has validated the first batch of ELISA sets produced by Zydus Cadila and found a similar sensitivity and specificity of 98.7 percent and 100 percent, respectively.
“The ICMR is conducting a national surveillance survey of 24,000 individuals,” it said.
According to the ICMR, the ELISA kit is cost-effective, sensitive, fast, and a large number of samples can be tested at any level of clinical setting, including public health centers and hospitals.
Following the development of the ICMR-NIV, the technology has been transferred for mass production to Zydus Cadila, which is an innovation-driven global healthcare company, the statement states.
The news came four days after NIV successfully developed the first original anti-SARS-CoV-2A (Covid-19) human IgG ELISA test kit for antibody detection of the deadly virus.
According to the ICMR, this robust test will play a critical role in monitoring the proportion of the population exposed coronavirus infection.
Union Minister of Health Very Vardhan had said on Sunday that the kit was validated at two locations in Mumbai and has high sensitivity and accuracy. In addition, it has the benefit of testing 90 samples together in a single 2.5-hour run, allowing healthcare professionals to quickly move on to the next steps needed on their patient’s triage paths. This is crucial as time is essential during a pandemic.
“ELISA-based testing is easily possible, even at the district level. ICMR technology has been transferred to Zydus Cadila for mass production. The Drug Controller General has granted Zydus commercial production and marketing authorization,” Harsh Vardhan said Sunday.
Most countries in the world are struggling to contain the spread of the pandemic through possible interventions. There is an increased demand for different types of diagnostic tests from countries around the globe.
Most of the Covid-19 diagnostic material is imported to India from other countries. Therefore, Indian scientists are tirelessly committed to developing indigenous diagnostics for SARS-CoV-2, the causative agent of Covid-19.