The government has roped in Zydus Cadila for mass production of the country’s first indigenous ELISA test kit for antibody detection of covid-19 which was developed by National Institute of Virology in Pune.
“ELISA based testing is easily possible even at district level. The @ICMR_NIV technology has been transferred to Zydus Cadila for mass-scale production. The Drug Controller General (DCGI) has granted commercial production & marketing permission to Zydus,” health minister Harsh Vardhan tweeted on Sunday.
ELISA, which is an abbreviation of enzyme-linked immunosorbent assay, is a test which measures the antibodies IgG present in the blood against the novel coronavirus SARS-CoV2. ELISA test kits have routinely been used to detect HIV infection in patients.
“This kit was validated at 2 sites in Mumbai & has high sensitivity & 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 necessary next steps on their patients’ triage paths,” Vardhan tweeted.
The test kit was developed in one month, as per Vardhan’s tweet, and will be used for surveillance of the Indian population to see how many people in the country have been infected with covid-19 since the pandemic hit Indian shores.
The tests are cost-effective, sensitive and rapid, allowing a large number of samples to be tested at any level of clinical setting, public health centres and hospitals.
There are also minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test, which is considered the gold standard for diagnosis of covid-19. The test has an advantage of having much higher sensitivity and specificity as compared to the several rapid test kits which have recently flooded the Indian market, the government said in a release.
To be sure, India has not had a good experience with antibody testing so far, with the controversy around faulty rapid antibody test kits imported from China’s Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics being a prominent issue.
Since then, the focus of the government has been to indigenously produce antibody test kits, with HLL Lifecare Ltd also working on its own testing kits using raw materials and technology imported from a Canadian firm.
News Source: Livemint