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The Hindu
The Hindu
National
Special Correspondent

Coronavirus | ICMR invites applications for validation of antigen detection tests

Anxious wait: People in line for COVID-19 test at a hotspot in northwest Delhi on Thursday. (Source: THE HINDU)

The Indian Council of Medical Research (ICMR) on Thursday invited applications for validation of rapid antigen detection tests for COVID-19 from manufacturers who have developed them. It acknowledged that the gold standard RT-PCR diagnostic test had limitations in terms of widespread availability.

It said that as India was lifting the lockdown in phases, it was expected to see an upsurge in cases. Hence, it was important to scale up the testing capacity to the maximum.

“The gold standard RT-PCR diagnostic test has limitations in terms of widespread availability. In view of this, there is an urgent requirement of reliable and convenient rapid point of care antigen detection assays with high sensitivity and specificity. Such assays could be used as potential diagnostic tests in all possible public and private healthcare settings and made available for mass testing. So far, the ICMR has validated and approved only one rapid antigen detection assay from SD Biosensor,” the ICMR said.

The ICMR has identified sites for validation of the rapid point-of-care antigen detection tests. These are the All India Institute of Medical Sciences, Delhi; SMS Medical College, Jaipur; King George Medical University, Lucknow; Kasturba Hospital for Infectious Diseases, Mumbai; Post-Graduate Institute of Medical Education & Research, Chandigarh; Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry; and the National Institute of Virology, Kerala Unit, Alappuzha

The essential criteria for validation are a minimum of 300 rapid antigen tests for each validation; a minimum of 3-4 instruments (if the results are to be interpreted using specialised equipment such as fluorescence immunoassay readers); the ability to provide training to technical staff involved in validation of the test; and the commitment on the part of manufacturers to make adequate supplies of the product available to India with immediate effect if the kit is approved after validation.

Union Health Minister Harsh Vardhan launched the ‘eBloodServices’ mobile application for accessing the blood services of the Indian Red Cross Society. The application is developed by the E-Raktkoshteam of the Centre for Development of Advanced Computing under the Digital India scheme launched by Prime Minister Narendra Modi in 2015.

Dr. Vardhan said, “Through this app, four units of blood can be requisitioned at a time, and the blood bank will wait for 12 hours for the person to collect it. This app makes it easy for those in need to request for blood units.”

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