Indian-owned company develops COVID-19 test kit

Sunil Vazirani.  

After the United States, Italy and Europe, India might soon see the deployment of antibody ELISA kits to know if a person has actually recovered from the COVID-19 coronavirus without even knowing that he or she had been infected, thus returning to a normal life without restrictions.

The kits will be put to use after they receive the approval of the Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices. They have been developed by scientists from India, the U.S. and the U.K. for Erba Mannheim, a company founded by Mumbai-based businessman Sunil Vazirani.

‘Not going away’

Speaking to The Hindu, Mr. Vazirani, who started TRANSASIA Bio-Medicals in 1979, long before he set up Erba Mannheim Germany in 1995, said that the world was realising the coronavirus was not going away without a vaccine.

“Our kits help identify individuals who had COVID-19, were asymptomatic and recovered without even knowing. They can thus confidently return to work and bring back normalcy to life, while reducing the stress on the frontline warriors," Mr. Vazirani said.

Italy is testing 5 lakh people a day using the kits developed by Erba Mannheim. Each kit can be used to perform 100 tests, Mr. Vazirani said. The kits took a month-and-a-half to develop.

After first receiving the European CE approval, Erba Mannheim also received the U.S. Food and Drug Administration’s nod for the advanced method of testing antibodies, which it claims is much faster than the rapid testing kits from China.

Mr. Vazirani claims that his COVID-19 antibody ELISA kits can test 100 samples an hour, with an accuracy rate of 98%.

Research tells us that the SARS-CoV-2 viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG antibody tests. IgM is produced first and is detectable during early onset of the disease. IgG is produced later and is maintained for long-term immunity. ERBA Mannheim’s kit, called ErbaLisa® COVID-19 ELISA kits, can detect both antibodies.

Through group company TRANSASIA India, Mr. Vazirani’s team has applied for permissions to use the kits in India, for which 500 sample kits have been imported.

“Antibody tests are important to do. India imported rapid test kits from China which, as per the Indian Council of Medical Research, have a 6-30% [rate of] accuracy,” he explained.

A team that includes Drugs Controller General of India Dr. V G Somani and others is looking into approvals for the antibody kits.

Asked how many people could actually be infected with COVID-19, Mr. Vazirani said, “It is anybody’s guess, but 20-30 times more than those [who have been] tested have been infected. Our understanding is that 80% of those infected don’t show symptoms.”

Existing plants

Once the approval is obtained, Mr. Vazirani plans to produce the kits at existing TRANSASIA India plants in Daman and Sikkim, which will further the setting up of a COVID-19 unit making only testing kits for the virus. This plant in Andhra Pradesh’s Med Tech Zone is backed by the World Health Organisation (WHO) and is awaiting necessary regulatory approvals and on-ground permissions.

For the future, Mr. Vazirani believes that the kits will help individuals test themselves, and also help companies test their employees in a big way.

“Everybody is worried. This is an easy and affordable test. It will help bring back confidence in people — that they have the antibodies. ,” Mr. Vazirani said.

Our code of editorial values

Related Topics
This article is closed for comments.
Please Email the Editor

Printable version | Sep 23, 2021 9:52:13 PM |

Next Story