Home » NIV’s kits to replace defective Chinese rapid test kits for COVID-19

NIV’s kits to replace defective Chinese rapid test kits for COVID-19

by Raju Vernekar
0 comment 2 minutes read

IT News
Mumbai, May 13,

The National Institute of Virology, Pune (Maharashtra) has successfully developed the first indigenous ELISA (enzyme-linked immunosorbent assay) test kit for the antibody detection of the novel coronavirus, with a capacity to test 90 samples together in a single run of 2.5 hours.
The ELISA test is similar to rapid antibody test since it looks for antibodies in the blood to ascertain if one has been infected with the coronavirus or not. The testing technique is used to detect antibodies in the blood of people who may have had coronavirus infection. This robust test will play a critical role in surveillance of proportion of population exposed to “SARSCoV2” infection.
The Indian Council of Medical Research (ICMR) has partnered with “Zydus Cadila Pharmaceutical Company” for the mass-scale production of these ELISA test kits. Due to the accuracy of the kit, healthcare professionals can proceed quickly with necessary steps on their patients’ triage paths, Union Health Minister Harsh Vardhan said in a  tweet.
These kits will be used to launch study of community transmission. ELISA based testing is easily possible even at district level. The Drug Controller General of India (DGCI) has already granted permission for commercial production and marketing of these kits to “Zydus”.
The kit developed by NIV, was recently validated at two sites in Mumbai. Developed in a month’s time, the testing kit would help to study the presence of “anti-SARS-CoV-2 IgG” antibodies in the Indian population. It is cost-effective, sensitive, rapid, and a large number of samples can be tested at any level of clinical setting, public health centres and hospitals.
At present, most of the diagnostic material for COVID-19 is imported into India, from other countries. India’s first attempt with rapid antibody test kits was not pleasant with the faulty test kits been imported from China’s “Guangzhou Wondfo Biotech” and “Zhuhai Livzon Diagnostics”. Huge variations in the accuracy….from 6 per cent to 71 per cent, of the test results were found, as compared  to results of the  real-time reverse transcription polymerase chain reaction (RT-PCR) tests done on the same positive samples. RT-PCR test can be run in a singleplex format (three individual assays) or multiplexed into a single reaction and amplification set up.
It may be recalled due to defective Chinese test kits, the ICMR had to recently cancel orders for about half a million Covid-19 rapid antibody test kits, which were imported from China.  Many states including Rajasthan and Maharashtra had complained about the inaccuracy of the Chinese test kits.

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