On May 10, 2020 Union Health Minister Harsh Vardhan informed that, Indian Council of Medical Research(ICMR)-National Institute of Virology(NIV) has developed the 1st indigenous anti-Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) human Immunoglobulin G(IgG) enzyme-linked immunosorbent assay (ELISA) test kit, “COVID KAVACH ELISA” for antibody detection of COVID-19.
- ICMR has partnered with Zydus Cadila, a global healthcare company for mass-scale production of the ELISA test kits after its development. The Drug Controller General has granted commercial production and marketing permission to Zydus
Major Highlights
i.The kit was validated at 2 sites in Mumbai & is found to have high sensitivity and specificity when compared to the several rapid test kits which have recently flooded the Indian market.
ii.It will have the advantage of testing 90 samples together in a single run of 2.5 hours. The testing is possible at the district level as the ELISA kit has inactivated virus.
iii.There are minimal biosafety and biosecurity requirements as compared to the real-time Reverse transcription-polymerase chain reaction(RT-PCR) test.
iv.The test developed in a month’s time will be used to screen 30,000 samples from 75 hotspot districts to study the presence of anti-SARS-CoV-2 IgG antibodies & understand the extent of spread of the virus.
v.It helps to know whether the person is infected by coronavirus & the people who have remained symptom-free(asymptomatic) during the entire course of the infection will test positive as it detects antibodies.
vi.Zydus Cadila is involved in developing a vaccine for COVID-19 & is hosting an animal trial phase and hopes to take it to clinical trials in the coming months.
Background
The ICMR has cancelled orders for about half a million COVID-19 rapid antibody test kits from China after they were found to be giving out inaccurate results.
ELISA kit is best from RT-PCR
RT-PCR detects the RiboNucleic Acid(RNA) of the coronavirus which enables the detection of current infection but is not effective if the virus is no longer being tested for days after infection.
Antibodies developed in the coronavirus infection will be present in the blood for a longer duration and hence the ELISA test can help detect past infection.
About ICMR:
Headquarters– New Delhi, India
Director General– Balram Bhargava
About NIV:
Headquarters– Pune, Maharashtra
Director– Priya Abraham
About Zydus Cadila:
Headquarters– Ahmedabad, Gujarat
Chairman– Pankaj R. Patel
Managing Director (MD)– Sharvil P. Patel
About Ministry of Health & Family Welfare:
Union Minister– Harsh Vardhan (Constituency– Chandni Chowk, Old Delhi)
Minister of State (MoS)– Ashwini Kumar Choubey(Constituency– Buxar, Bihar)
