The Indian Council of Medical Research (ICMR) approved Indian biopharma company Transasia’s ELISA antibody IgG testing kit for Covid-19 on Wednesday. The approval comes for Transasia’s USA manufactured kits, the Mumbai-headquartered company has also applied for approval of its domestic IgG and IgM kits.
Enzyme-linked immunosorbent assay (ELISA) test detects presence of antibodies developed in body against the virus. The test can produce results within an hour and cost less than real time polymerase chain reaction (RT-PCR) tests. In Spain, Italy, Germany and several other European countries ELISA test is being done as an “immunity passport” for people to return to work.
Transasia is first Indian company to get ELISA kit approved in country. In May, ICMR developed the technology for ELISA in National Institute of Virology, Pune, and transferred the technology to Zydus Cadilla for mass production of kits. Cadilla supplied 30,000 kits last month to ICMR, which plans to use the kits for surveillance.
“Our kit has got approval in several other countries. We are distributing in USA, Europe, Latin America, Russia. In Vishakhapatnam, we plan to set up another factory for manufacturing kits,” said Suresh Vazirani, managing director of Transasia. Vazirani said the kit allows 96 samples to be tested in one hour. “In a month, we have capacity to provide 3 crore kits,” he said, adding that cost for the kit is yet to be decided. “It will be much lower than RT-PCR,” he said.
This will be amongst the first to be commercially available in market for Covid-19 surveillance.
An ELISA test is conducted on blood, is faster and cheaper than PCR test. It detects presence of antibody even if infection was contracted months ago. In several countries it is being used for surveillance to check how many people in community are infected by Covid-19 and have developed antibodies against it. A rapid test also detects antibodies against infection but is considered less accurate than ELISA.
A microbiologist with Sion hospital in Mumbai, Dr Sujata Baveja, said, “There are two types of ELISA tests, an IgG and IgM. IgG detects antibodies developed in later stage of infection, and IgM detects antibodies produced in early stages of infection. For Covid-19, ELISA test can only be used for surveillance, for diagnosis of patients we will continue to rely on RT-PCR tests.”
Transasia has domestically manufactured both IgG and IgM, the domestic kits are yet to get approved for Covid-19 testing. It took 20 days to verify the sensitivity of test for Covid-19 in ICMR.
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