India is banking on a locally developed, affordable home-use kit to bump up testing for COVID-19 and reduce the burden on public resources struggling against a runaway pandemic now raging through the country in a deadly second wave.
The second wave that hit India in March 2021 saw severe shortages of vaccines, hospital beds and medical oxygen. On 30 April, India became the first country to report over 400,000 new cases in a 24-hour period, badly overwhelming public health resources.
Called CoviSelf, the new Rapid Antigen Test (RAT), which costs US$3.50, takes 15 minutes to indicate whether a nasal or throat swab placed on a strip of paper is positive or negative.
Following approval by the Indian Council of Medical Research (ICMR), India's top body for the formulation, coordination and promotion of biomedical research, the Pune-based developer, Mylab Discovery Solutions, has announced mass manufacture of the kits.
Sujeet Jain, director of the company, says that the kit will be available across the country through most pharmacies as a prescription-free, over-the-counter product to any buyer by early July. "We plan to produce 40 to 60 million kits per month," Jain tells SciDev.Net.
According to an ICMR advisory on the kit, published 19 May, home-testing is advised only for individual with symptoms of COVID-19 and immediate contacts of laboratory-confirmed positive cases.
The ICMR advisory asks users to follow instructions given as pictorials and in a video. A mobile smartphone app analyses a picture of the swab to issue a positive or negative result.
Rapid antigen tests are of great value when the burden of the disease is huge as in India where the case load (is) increasing rapidly and labs aren't able to cope with the massively increased demand for RT PCR tests."
Dinesh Raj, Consultant, Holy Family Hospital, New Delhi
According to ICMR, India has cumulatively conducted tests on almost 337 million samples since mass testing began in March 2020. That figure represents less than a quarter of India's population of around 1.3 billion people.
"If someone tests positive, those close to him can get a RAT done," Raj tells SciDev.Net.
However, he adds that it is important for the public to know that RAT has poor sensitivity and that there is a high possibility of error, meaning results should be checked with a standard RT-PCR test.
"It is likely to miss cases and give false negative results," he says. "An individual with negative RAT may feel falsely confident and continue to spread disease while his own condition may deteriorate."
Suma Balan, professor of rheumatology at the School of Medicine, Amrita Vishwa Vidyapeetham, Kochi, Kerala, tells SciDev.Net the kit will "help patients who are unable to go to a test centre, which are all currently overburdened so that the wait for RT-PCR test results can be up to three days in cities like Delhi".
"The real question is whether this new product will live up to its reputation as is being advertised," she adds.
Posted in: Device / Technology News | Disease/Infection News
Tags: Antigen, Coronavirus, Hospital, Laboratory, Medical Research, Medicine, Oxygen, Pandemic, Research, Rheumatology, Throat
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