New Delhi: FICCI today released a Whitepaper on ‘Economical, Accurate and Scalable COVID-19 Testing Solutions’ as the need for India’s seroprevalence studies, to base its pandemic management strategies and future initiatives as lockdown is getting lifted across the country. It is significant to note that recently ICMR released a communication on the list of antibody tests that are available for such studies, especially with high-risk groups like healthcare workers.
FICCI has been at the forefront of government-industry collaboration in managing the COVID-19 situation in India. FICCI IVD members, constituting Indian healthcare and regulatory system came together to build an ecosystem of safety measures, diagnostic testing, and medical intervention to contain and control mortality relating to COVID-19 infections in India.
Dr Sangita Reddy, President, FICCI & Joint Managing Director of Apollo Hospitals Enterprises said, “It is a moment of great action and contemplation as we balance meeting immediate healthcare needs of India with planning for the future to manage the negative impact of COVID-19. I am glad that FICCI is able to truly value-add to this journey. The COVID-19 experience is new to all of us, but I am confident that we shall have a lot to take back from this experience as learnings, to build an Indian healthcare system that is resilient to any future situation. The Whitepaper is an effort in this direction, giving us some keen insights into seroprevalence studies with diagnostic testing, and how they impact COVID-19 management investments and plans of the future.”
From the onset of the pandemic to date, diagnostics have been at the heart of the discussion. RT-PCR based molecular testing has been enabling detection of the novel Corona Virus, while antibody testing is aimed at assessing the spread of infection to plan mitigation measures and assess the safety of returning to work.
Dr Shravan Subramanyam, Co-Chair, FICCI Medical Devices Committee & Managing Director, Roche Diagnostics India said, “India needs to focus on technology agnostic solutions that offer the best clinical outcomes (e.g. sensitivity and specificity) to measure exposure and potential immune response with SARS CoV-2 antibody tests. Fully automated lab-based Serology antibody tests are being widely adopted by several countries, including Singapore, which is leveraging CLIA to screen 300K migrant workers, UK, which announced that it is employing similar tests as a mass screening tool, especially for its healthcare workers and the US which is planning to launch a 25-city COVID-19 antibody study in June/July. India has such capabilities today and needs to leverage it to build data and plans its future healthcare strategy.”
Mr Ravi Sinha, Country Director India & SAARC, Ortho Clinical Diagnostics said, “Across India, people from all strata of life are being impacted by COVID-19 pandemic. Antibody testing using tests with excellent specificity is an optimal answer for large-scale testing, as it helps to ensure more people receive accurate results they can trust. Sero-surveillance will help monitor and manage those patients fighting active infection, and those who have developed antibodies may be able to return to work, destressing individual communities and re-boosting our economy. We must leverage the strong healthcare infrastructure built over decades, across the nation, towards improving and saving lives with diagnostics. Performing antibody testing on fully automated using U.S. FDA (EUA) & DCGI approved assays will help provide faster, reliable, and accurate patient results.”
Mr Narendra Varde, General Manager and Country Head at Abbott’s diagnostics business in India said, “Abbott recognizes that large scale antibody testing is critical to understanding and addressing the COVID-19 pandemic. Lab-based serology test’s high performance and relevant data can help uncover new insights, including prevalence at local, state or countrywide levels. We welcome ICMR’s recommendation of IgG testing to measure COVID exposure in the population including asymptomatic individuals. Our recently launched Abbott SARS-CoV-2 test has demonstrated specificity and sensitivity to detect IgG antibodies of greater than 99 percent, and we want to do our part in providing hospitals and reference labs around the country with access to reliable testing.”
Mr Arpan Malhotra, India Business Head – Diagnostics, Siemens Healthcare Private Limited said, “Country is now moving towards a need for mass screening and community surveillance for COVID-19. Laboratory based antibody tests (CLIA) are not just higher in sensitivity, but are also scalable to very high throughputs. This can enable an increased expanse of COVID-19 testing to larger population via already available network of thousands of government and private facilities, that are equipped for this testing.”
A high-specificity test will identify people who have been truly exposed to SARS CoV-2 and will not generate many false-positive results.
At this point, we would encourage the ICMR & MoHFW to expand the COVID-19 Testing Strategy and release a protocol that covers both PCR and Lab-based Serology tests, while leveraging on infrastructure and spread of private hospitals and labs across India to build access to antibody testing.