The scientific community across the world has found it a daunting challenge to keep pace with the rate of spread and unpredictability of the virus, comparing the experience of finding solutions to Covid-19 to something like learning to fly an air-plane while riding one.
Through this unprecedented challenge of the last ten months, the Central and State governments have stepped up remarkably to offer ‘evolving’ guidance amid rapidly shifting realities. The apex scientific regulatory bodies, mainly the Indian Council of Medical Research (ICMR) has also been responsive and attentive to the needs of the industry, helping it course-correct, innovate, and build capabilities, beyond its own expectations at times.
This pragmatic approach among other factors has helped check the trajectory of the pandemic in India, arguably much more effectively than in many more developed countries. However, given the heterogeneity and complexity of the Indian landscape, challenges persist.
While the scaling up of testing infrastructure in India has set a good benchmark, given how populous our country is and until vaccination is available to everyone, testing and tracing will remain vital. One of the biggest debates over the last few months was about which tests to administer, Real-Time Reverse Transcription-Polymerase Chain (RT-PCR) or Rapid Antigen Test (RAT). Now, we know that each test serves it purpose, and is important according to the situation on the ground.
While one is not sure how long the immunity will last post vaccination, the threat of more potent mutation is rising, and with the economy, schools and offices opening up, testing consistency needs to be maintained in identifying hotspots and curbing the spread of the virus. Across the country, there are many places that remain under-served by RT-PCR, and even in big cities and metros where RT-PCR test is available, long turnaround time running into several days defy the point of testing for patients many times, particularly when cases surge.
Against this backdrop, India needs to explore alternatives for accurate tests and technologies that can supplement RT-PCR tests in confirming diagnosis for one or more categories of Covid-19 patients in the least possible time.
Innovation has been central to the pandemic response, be it from new testing technologies to new modes of vaccines, led by development of mRNA vaccines in record time. We need to adopt these newer testing technologies for efficient and quick response to the Covid crisis. That is where the new and innovative tests such as Ortho Clinical Diagnostics VITROS SARS-CoV-2 Antigen test, and Reliance Group-Breadth of Health’s breadth test system come into the picture.
With 97.8 per cent sensitivity and 99.2 per cent specificity, Ortho’s SARS-CoV-2 antigen tests offer exceptional utility for mass-scale testing and work as a viable alternative to RT-PCR testing. It is a high-throughput laboratory-based test and highly sensitive as well with 100 per cent PPA with RT-PCR within 1-5 days of symptom onset. Ortho tests also have an average turnaround time of two hours. This is considerably better than RT-PCR tests, which takes a day or two to get the reports, when demand is low, and could easily extend to several days with surge in demand.
Reliance Group-Breadth of Health’s breadth test is another innovative testing system that identifies Covid-19 at a success rate of over 95 per cent. Preliminary results from clinical trials in Israeli hospitals have shown a success rate of 98 per cent compared to the standard PCR tests. As Covid-19 is prolonged, and new variants of the virus mutate, it is necessary that new and innovative tests built on higher specificity and quick results are introduced as soon as possible. These new tests along with enhancing of sequencing facilities will also help in sequencing of the new mutations of the virus, which is important, as new, and deadlier mutations of the virus emerge across the world.
Second, third wave
As many countries are suffering from the second and third wave of the pandemic, it is important these new testing technologies are approved as soon as possible for mass deployment in India.
Also, as the country is on the vaccination path, we need to develop and approve tests that can differentiate a vaccinated person from a naturally infected person, to avoid complications. This will help verify the responders and non-responders, the need of booster dose for those selective group of people which helps to curb the spread of Covid-19.
We are already seeing countries such as the US, Spain and Italy take the lead in permitting usage of new testing technologies. Many innovative tests promote self-testing such as nasal swab tests, and saliva tests can be done at home without any prescription and trained manpower.
China has introduced anal swabs tests, to detect Covid more accurately in key groups such as those in quarantine or have a history of travel to hotspot regions.
Oropharyngeal specimen negativity been described together with anal swab positivity up to 28 days after the onset of symptoms also in in children. This suggests that some patients with SARS-CoV-2 infection have viral RNA or live infectious virus in feces well after the negativisation of oropharyngeal specimens. If India continues to delay the validation of accurate, viable, cheaper, and more convenient to use tests, the country could lose from benefiting in quick and accurate testing of undiagnosed infection, untreated patients, and possibly even avoidable deaths. The price and turnaround time make it apt for mass-testing for organisations and States, as India slowly reopens its economy.
They could be deployed at high movement centres such as airports, railways stations, bus stands, etc., to reduce testing times and increase passenger conveniences. India has done a commendable job in tackling the spread of the virus, through its massive scale-up of testing and tracing infrastructure.
Though the vaccination campaign is under way, vaccinating a considerable amount of the population will take time. It is vital that India goes for the kill, by approving new and innovative testing solutions, which can have an immediate impact.
The writer is former Director General, Indian Council of Medical Research
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