- Factory has been set up at Andhra Pradesh MedTech Zone in Visakhapatnam
- To make Elisa-based antibody detection test kits, RT-PCR kits and rapid test kits
- To make 10 lakh Elisa-based antibody detection test kits per day
- The 35,000 sq ft facility is claimed to be the largest in Asia to make COVID-19 products
Mumbai-based Transasia Bio Medicals, the largest domestic laboratory diagnostics maker, has set up a factory at Andhra Pradesh MedTech Zone in Visakhapatnam to manufacture various COVID-19 diagnostic kits. The unit is claimed to be the largest in Asia for its capacity.
The Vizag factory, now ready and spread over 35,000 sq.ft of production space, is planning to make Elisa-based antibody detection test kits, RT-PCR (reverse transcription-polymerase chain reaction) kits and rapid test kits within one month's time as final approvals from various Indian regulatory agencies are awaited, Suresh Vazirani, chairman and managing director, Transasia Bio-Medicals said.
About five days ago, the Indian Council for Medical Research (ICMR) had sanctioned import of Elisa test kits developed by the R&D team of Transasia's US subsidiary Calbiotech Group of Companies. The US Food and Drug Administration (FDA) and the European Union (EU) have already cleared the product and Transasia supplies the kits to the US, Italy, Spain, Brazil and many countries in the developed world. Calbiotech makes about 10 lakh Elisa kits per day. Transasia is among a dozen suppliers of such kits to the US, which is currently testing its citizens with about 10 lakh Elisa tests per day. The kit was developed by Transasia within one and half months of research and had got the US approval within a week's time, said Vazirani.
"At present, we are looking at supplying about one lakh imported kits from the US and once domestic manufacturing begins, we can supply at half the price of RT-PCR kits, at less than Rs 1000," said Vazirani. India is yet to start extensive use of Elisa testing. An indigenous Elisa test named "Covid Kavach Elisa" developed by the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune has been transferred to Ahmadabad-based drug maker Zydus Cadila for mass scale production. A Biocon Group company Syngene and a couple of domestic manufacturers also have developed Elisa test kits using the ICMR technology, said sources.
Elisa stands for Enzyme-linked immunosorbent assay. Elisa test platforms have been used for many decades to detect infectious diseases like Hepatitis-B, Hepatitis-C and HIV and the machines are available in most of the diagnostic labs. Elisa tests can detect antigens by measuring blood components like IgM and IgG. The test will determine whether the blood sample has developed antigens (in IgM) during onset of disease and long-term immunity after a few days of infection with the IgG tests.
While real time RT-PCR is the front-line test for clinical diagnosis of SARS-CoV-2, antibody tests are critical for surveillance to understand the proportion of population exposed to infection. It will help find if 'herd immunity' is developing in a population. The advantage is it is easy to test large population in non-laboratory set ups with faster turnaround time and at cheaper rates than RT-PCR tests. Another advantage is that it can test 100 samples in an hour compared to very few samples in RT-PCR. Further, it has an accuracy rate of 98 per cent, whereas RT-PCR accuracy rate is only 30-35 per cent.
Vazrani established Rs 1,300-crore turnover Transasia Bio-Medicals in Mumbai in 1979. The firm focusses on laboratory diagnostics and equipment. In 2002, Transasia acquired Europe-based Erba Mannheim and its subsidiaries in the US, UK and Germany and grouped under Transasia-Erba Group.