Amit Chopra, Managing Director, India and South Asia, Thermo Fisher Scientific, explains Express Healthcare about acceptance of point-of-care testing in India and his company’s AcculaSARS-CoV-2 test
Tell us something about the AcculaSARS-CoV-2 Test
The AcculaSARS-CoV-2 Test is a rapid molecular point-of-care test that combines the accuracy of RT-PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula System has received Emergency Use Authorisation (EUA) from the US FDA for in vitro diagnostic testing of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)–waived environments. The test utilises polymerase chain reaction (PCR) and lateral flow technologies that enables shortened cycling times without the need for costly thermal cycler hardware and optical detection systems used in lab-based RT-PCR. The Accula SARS-CoV-2 Test uses nasal swab specimens, collected from patients suspected of COVID-19 by their healthcare provider. All the steps of sample testing are fully integrated for decentralized use at the point of care. This portable, easy to use, qualitative and rapid PCR-based test provides visual results within approximately 30 minutes.
How different is this test from the other available in market?
The Accula SARS-CoV-2 Test is a point-of-care test that uses gold standard RT-PCR technology. The exponential amplification of nucleic acid targets by nucleic acid amplification tests (NAAT) methods enables detection of very small amounts of SARS-CoV-2 RNA in a specimen, unlike antigen (Ag) based tests that do not amplify their protein targets, hence are generally less sensitive.
With performance characteristics equivalent to lab-based PCR testing for SARS-CoV-2 as confirmed by FDA reference panel, the test has a limit of detection (LOD) of 475 NDU/ml. With operational aspects enabling rapid, decentralized deployment, it is a best in -class solution uniquely positioned to address the requirements for timely results with high sensitivity and specificity.
Where can patients access these tests and what are your plans to make this test widely available?
At Thermo Fisher, we are inspired by our mission, which is to enable our customers to make the world healthier, cleaner and safer. Our efforts are to ensure we are providing the right solutions at the necessary scale, with highest quality, and reliability. We will continue to leverage on our operational excellence, and existing distribution channels to ensure uninterrupted supply of instruments and consumables. Further, we are collaborating with new channel partners to expand our distribution networks to make the tests widely available in India.
The tests will be available in all diagnostic labs/ hospitals (private and government) approved by ICMR. Apart from this, the tests can be used in places like airports, ICU settings, ambulances, defence, sports arenas, and other important set-ups for safe return to work/activities.
How do you foresee acceptance of point-of-care testing in India especially when there are several players and testing options available?
Fast, accurate, and cost-effective point-of-care (POC) COVID-19 tests are set to revolutionise the testing market. Point of care tests are based on a variety of technologies and formats both old and new, like the conventional antigen-based tests for detecting viral proteins; nucleic acid amplification tests (NAAT) and loop-mediated isothermal amplification (LAMP) for the detection of viral genetic material. The volume of point-of-care (POC) testing has risen during the COVID-19 pandemic and there is sustained focus on testing leading to adoption of new and advanced technologies that offer reliable yet faster results.
The Accula point of care device is an ideal solution that addresses requirements for timely results with high sensitivity and specificity using the gold reference RT-PCR technology. As the point-of-care diagnostic market expands, at Thermo Fisher we are well -positioned to support healthcare bodies and government with more options and flexibility for COVID-19 testing. These tests will significantly bolster India’s response against COVID-19, fast-track reopening of economies and strengthen the overall healthcare capabilities for infectious disease management in the country.