After the United States, Italy and Europe, India might soon see the deployment of antibody ELISA kits to test if a person has truly recovered from the coronavirus without even knowing that he or she had been infected. This test can help to return back to a normal life without restrictions.

After the approval of the Central Drugs Standard Control Organization, the kits will be made available for use. The kits are developed by scientists from India, the U.S. and the U.K. for Erba Mannheim, a company that is established by Mumbai-based businessman Sunil Vazirani.

Mr. Vazirani, had started TRANSASIA Bio-Medicals in 1979 and he set up Erba Mannheim in Germany in 1995. He said that the coronavirus was not going away without a vaccine from this world. The kits can identify individuals who had coronavirus, and were asymptomatic and who recovered without even knowing. They can positively return to work and bring normalcy back to life, while reducing the stress on the frontline warriors.

Italy is testing 5 lakh people per day using these kits which are developed by Erba Mannheim. Each kit can perform 100 tests. The kits almost took a month-and-a-half to develop.

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

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

Research studies states that the SARS-CoV-2 viral antigens stimulate the body’s immune system to produce antibodies and are detected with IgM and IgG antibody tests. IgM is first produced and is measurable during early onset of the disease. IgG is produced much later and is maintained for long-term immunity.

ERBA Mannheim’s kit, called ErbaLisa® COVID-19 ELISA kits, can detect both these antibodies.

Mr. Vazirani’s team has already applied for permissions to use the kits in India through group company TRANSASIA India, and 500 sample kits have been imported. A team including Drugs Controller General of India Dr. V G Somani and others to look into approvals for these antibody kits.

After the approval, Mr. Vazirani is planning to produce the kits at existing TRANSASIA India plants in Daman and Sikkim that will further set up of a COVID-19 unit manufacturing only testing kits for the virus. The plant in Andhra Pradesh’s Med Tech Zone is supported by the World Health Organization (WHO) and is awaiting the required regulatory approvals and on-ground permissions.

Mr. Vazirani considers that the kits will help the individuals to test by themselves, and help companies also to test their employees in a huge way. He further said that everyone is worried around the world. This kit is an easy and affordable test, which will bring back confidence in people whether they have the antibodies or not. If the kit is approved, COVID-19 testing speed and accuracy might increase significantly.

Source: The Hindu