Four days after successfully developing the first indigenous anti-SARS-CoV-2A (Covid-19) human IgG ELISA test kit for antibody detection of the deadly virus, the ICMR on Thursday said that the first batch of the ELISA kits produced by Zydus Cadila has similar sensitivity and specificity of 98.7 per cent and 100 per cent, respectively.
The ICMR said in a statement that the National Institute of Virology (NIV), Pune, has validated the first batch of ELISA kits produced by Zydus Cadila and found similar sensitivity and specificity of 98.7 per cent and 100 per cent, respectively.
"The ICMR is in the process of carrying out a national surveillance study with 24,000 individuals," it said.
According to the ICMR, the ELISA kit is cost-effective, sensitive, rapid and a large number of samples can be tested at any level of clinical setting, including public health centres and hospitals.
After the development at the ICMR-NIV, the technology has been transferred for mass production to Zydus Cadila, which is an innovation driven global healthcare company, the statement said.
The news came four days after the NIV successfully developed the first indigenous 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 the surveillance of the proportion of population exposed to coronavirus infection.
Union Health Minister Harsh Vardhan had said on Sunday that the kit was validated at two sites in Mumbai and has high sensitivity and accuracy. Besides, it has the advantage of testing 90 samples together in a single run of 2.5 hours, so that healthcare professionals can proceed quickly with the necessary next steps on their patients' triage paths. This is crucial since time is of essence during a pandemic.
"ELISA based testing is easily possible even at the district level. The ICMR technology has been transferred to Zydus Cadila for mass production. The Drug Controller General has granted commercial production and marketing permission to Zydus," Harsh Vardhan had said on Sunday.
Most countries in the world are struggling to contain the spread of the pandemic using possible interventions. There is an augmented demand of various types of diagnostic tests by countries across the globe.
Most of the diagnostic material for Covid-19 is imported into India from other countries. Therefore, Indian scientists are tirelessly engaged in developing indigenous diagnostics for SARS-CoV-2, the causative agent of Covid-19.
( With inputs from IANS )