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First Indian antibody detection kit for Coronavirus

COVID KAVACH ELISA

Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) at Pune developed the indigenous IgG ELISA test named “COVID KAVACH ELISA” for antibody detection for COVID-19 which is the first Indian antibody detection kit for Coronavirus.

Covid-19 continues to spread across the globe, thus, the demand for testing kits is also increasing. India imports most of these diagnostic kits from other countries.

  • As you might already know that India has canceled orders for about half a million rapid testing kits from China after they were found to be faulty.

Therefore, Indian scientists worked tirelessly to develop indigenous diagnostics for Covid-19.

While real-time PCR (q-PCR) is the frontline test for diagnosis of SARS-CoV-2, these antibody tests are important in understanding the proportion of the population that has been previously exposed to certain infections.

This has been validated and approved by the government, and will now be mass-produced and used in the community-based survey. The test was validated at two sites in Mumbai and has been found to have high sensitivity and specificity.

This will provide information about the spread of SARS-CoV-2 infection in different parts of the country.

Dr. Harsh Vardhan, India’s Minister of Health and Family Welfare,-“The robust indigenous IgG ELISA test for antibody detection developed by ICMR-NIV, Pune will play a critical role in surveillance of proportion of the population exposed to SARS-CoV-2 Coronavirus infection.”

He added that the technology was developed by ICMR and NIV in a month’s time.

It is one of the perfect examples of Made in India in record time and so-called “self-dependency” by Indian PM Narendra Modi in his speech on 13th May.

WHY COVID KAVACH ELISA?

It can test 90 samples in a single run of 2.5 hours and it is of course cost-effective. It can be done even at the district level as the ELISA kit has inactivated virus. Minimal bio-safety and bio-security requirements as compared to the real-time RT-PCR test.

The test has much higher sensitivity and specificity as compared to the several rapid test kits currently flooded the Indian market.

Now, it’s time for some basics.

What are antibodies?

An antibody is a large, Y-shaped glycoprotein produced mainly by plasma cells of B-lymphocytes that are used by the immune system to neutralize and destroy pathogens such as pathogenic bacteria and viruses.

There are five immunoglobulin classes (isotypes) of antibody molecules found in serum based on the type of heavy chain they contain: IgG, IgA, IgM, IgD, and IgE.

More about IgG antibodies

IgG is the most abundant antibody molecule and accounts for around 75-80% of the total antibodies of the body and it is monomeric in nature. IgG appears about 24–48 hours after antigenic stimulation. It has 4 sub-types namely IgG1, IgG2, IgG3, IgG4.

About ELISA:

ELISA stands for “enzyme-linked immunosorbent assay”. There are different types of ELISA. An indirect ELISA test is based on the detection of antibodies (produced against an antigen), in this case, the antigen is a novel coronavirus or its associated proteins.

Thus, it can only work if the person has been previously infected by the novel coronavirus.

Sometimes it takes one-three weeks for the antibodies to develop in response to infection. so if a person who has been recently infected by the coronavirus is tested, it might give the result to be negative. But a repeat test after a couple of weeks will indicate the true infection status. It all depends on the production of antibodies by the body on the onset of infection by a pathogen, in this case, the SARS-CoV-2.

COMMERCIALISATION 

In order to begin the deployment of these kits across the country ICMR-NIV has signed a ‘non-exclusive agreement’ with Cadila Healthcare Ltd. (Zydus Cadila).

“The Drug Controller General has granted commercial production & marketing permission to Zydus,”-Dr. Vardhan said.
First batch has already manufactured by Zydus-Cadila.

ICMR has also been approached by Cipla and NextGen Life Sciences regarding a non-exclusive license for “COVID KAVACH ELISA”, which is currently under process.

It is said to be available very soon.


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