The task force set up by the Indian Council of Medical Research (ICMR) has recommended launching a biobank or repository of test samples to understand clinical patterns in coronavirus cases, expedite test kit validation, and study the immune response to the virus. Follow coronavirus pandemic LIVE updates
While samples are being discarded currently, the task force members overseeing diagnostics and biomarkers said the agency has selected at least nine ICMR laboratories with easy access to COVID hospitals, where they can store positive and negative throat, nasal, and blood samples for research purposes. They added that the standard operating procedures for the project is being laid out.
“We can record clinical, demographic, social factors with the samples and use it for cutting-edge research, including genome sequencing,” said a task force member.
“Also, we have 60 to 80 test kits undergoing validation at any time and we need 50 to 70 positive and negative samples daily to test these,” another member said. “We need a larger body of samples to decrease the time of validation as we are seeing a large increase in manufacturers coming to us with new kits that need testing.”
Along with an increasing number of diagnostic test kits requiring validation, the agency has received 190 products for validation, including PPE fabric, masks, gloves, mobile applications, herbal formulations, ayurveda formulas, and hand sanitizers.
As the validations required moves beyond capacity, new guidance on Friday stated that the Cabinet Secretary has directed the agency to harness other institutes in Science Departments, such as the Department of Science and Technology (DST), Department of Biotechnology (DBT) and Council of Scientific and Industrial Research (CSIR).
Commercial manufacturers of technologies, diagnostic kits, and AYUSH regimes will now send their products to designated institutes, while ICMR’s own centers will still validate diagnostic kits, viral transfer mediums, and RNA extraction kits. In addition to the bio-repository, the task force has also recommended validating a new antibody assay that would help determine the level of protection a patient has against re-infection.
The new test kit could guide a hospital discharge policy and help determine the efficacy of a future vaccine.
“We still need to find at what level can we call a patient protected or unprotected from reinfection. When we find a patient positive for antibodies, there is no scientific evidence to say they are truly protected or not. Rather than only finding antibodies, we can look for neutralizing antibodies. This would help say a little bit more that the patient is protected,” the second member said. Neutralising antibodies bind to the virus in a way that blocks the infection.
“How long do antibodies last in a patient? How long does the virus or RNA last? We have many unknown questions with reports of people who clinically improve but still show positive tests… And other reports that those who test negative are then later becoming positive again,” said the second member.
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