How Covid-19 Testing Moved from RT-PCR to Home-based Kits
The much-feared third wave of the Covid-19 pandemic, borne by the Omicron variant of the coronavirus, came, saw, but didn’t conquer. And thank goodness for that. But while the wave created barely a ripple, it did bring in a new dynamic into the testing ‘industry’, one that looks set to stay with us for the foreseeable future. And that is the rise of home-based rapid antigen test (RAT) kits as a significant and more private—albeit not quite as effective—alternative to the now ubiquitous RT-PCR test. RAT is a point-of-care test that is used for quick diagnosis of an infectious disease, at home or in an emergency situation before admitting a patient into a hospital. The “at home”, “innovative” and “quick” Covid-19 testing idea is being sold smartly offline and online, giving rise to an entirely new market in the Indian pharmaceutical and diagnostics industry.
In May 2021, the Indian Council of Medical Research (ICMR) had approved a home-based RAT kit manufactured by Mylab Discovery Solutions, Pune. Since then, Abbott, Tata Medical and Diagnostics, and Trivitron Healthcare have also entered into the home-based Covid-19 testing business, and several others are planning to jump in soon. This helped ramp up the testing numbers during the Omicron wave in December-February. As on March 10, 2022, India had conducted 775,336,978 tests out of which 441,517,381 were RT-PCR and 333,819,597 were RATs, including 594,541 home-based RATs, according to the ICMR. In fact, according to the Union health ministry, more than 200,000 home test kits were used in the first 20 days of January 2022—when Omicron was at its peak—in contrast to just 3,000 since May 2021, when the ICMR approved Covid-19 home tests.
Dr Balram Bhargava, Director General, ICMR, points out that the increase in uptake of home based Covid-19 tests has happened “even though there are plenty of testing commodities ranging from RT-PCR to rapid antigen tests or ancillary equipment like viral transport medium or RNA extraction kits”. Bhargava also says that while home testing picked up fast, some states and districts recorded a decrease in Covid-19 testing in parallel, possibly as an outcome of the rise in home testing, which is difficult to record officially. “Home testing is increasing globally, and also in India, due to the ease of performing it in the safety of one’s home, instant result availability, repeatability, and ready availability at the nearest chemist,” explains Dr Harsh Mahajan, Founder of Mahajan Imaging, a diagnostic imaging centre in Delhi.
An Emerging Business
From the baseline demand of a few thousand kits, Mylab has witnessed a jump in sales of almost 500 per cent of its self-test kit—CoviSelf—since December 2021. Hasmukh Rawal, MD and Co-founder, Mylab Discovery Solutions, says this surge is because of supply and demand side forces. “The customer needs an instant test at low cost as soon as symptoms show up, without stepping out. RT-PCR labs, on the other hand, are not able to handle the increasing volume of tests,” he says, adding that the market will expand as schools, colleges and offices re-open. “The market for self-test kits will grow at least for the next two years,” says Rawal.
But there’s a catch. According to industry experts, RT-PCR has 100 per cent accuracy as it uses a molecular technique that is the gold standard in diagnostics. RAT kits are 70-80 per cent accurate, but when positivity rates are high, they are still very useful because when a rapid test shows you as positive, it is certain to be positive.
Tata Medical and Diagnostics’ RAT kit is slightly more advanced—it can detect both Delta and Omicron variants. “Along with Tata MD’s Express PCR instrument, the kit is able to provide quick PCR reports at a large scale. It is ideal for locations like airports, hospitals, and events where gold-standard accuracy is required with quick results,” says Dr V. Ravi, Head, R&D at Tata Medical and Diagnostics.
Trivitron Healthcare’s Covid-19 self-test kit has recently been validated by the ICMR. Chandra Ganjoo, Executive Director of Trivitron, says the rising demand for antibody tests is expected to drive the market for Covid-19 RAT kits. “These rapid test kits will be shaping and changing our lives over the coming years,” says Ganjoo, adding that even if new Covid-19 variants were to emerge, self-test kits would flourish, become cheaper and ubiquitous like home pregnancy tests. She says home testing kits are portable, reliable, easy to administer, and more economical than laboratory-based tests, enabling countries to increase the pace of testing, tracing, and treating people particularly in small towns and villages where the healthcare system is under-resourced.
The big challenge wrought by self-test kits is the under-reporting of Covid-19 cases. “Our test kits have a mechanism by which the suspected patient can intimate their status on our mobile application by just uploading the picture of their reports, which is then sent to the ICMR portal,” says Rawal. Meanwhile, the Food and Drugs Authority (FDA) divisions of several states have asked manufacturers, distributors, chemists, and dispensaries to maintain sale records of RAT kits, along with addresses and mobile numbers of the buyers. Those selling the kits have to also ask the buyers to download an application of the manufacturer and upload their test reports. If the buyers test positive, they have to inform the nearest government hospital or their doctor, and update the report onto the online ICMR portal. Still, there are concerns. “While regulating the sale and use of these testing kits is ideal, uploading of results would still depend on the end user,” says Mahajan of Mahajan Imaging.
The Road Ahead
Experts say that the future of these tests would depend on the trajectory of the pandemic. “Since, in due course, Covid-19 is expected to become endemic, the long term usage of these tests may be limited,” says Mahajan.
But the market of home-based tests and Covid-19 testing at large is transforming. For instance, Abbott has globally introduced 12 different Covid-19 tests to work in a variety of settings and stages of infection, including the fastest molecular point-of-care platform, lab-based molecular and serology tests, professional rapid antigen tests, and self-tests. “India’s diagnostics sector is evolving rapidly, encompassing novel innovations in testing across a variety of point-of-care settings. This has spurred the decentralisation of testing and the formation of the newest category of self-testing,” says Sunil Mehra, General Manager for Abbott’s Rapid Diagnostics Business in India.
The quality of self-testing technologies is improving, too. For example, one of the latest home-based Covid-19 testing kits by Abbott is Panbio Covid-19 Antigen Self-Test, which has reported a sensitivity of 95.2 per cent and specificity of 100 per cent, indicating high accuracy in detecting active infections, especially in more infectious cases with higher viral load.
Epidemiologists, however, are concerned that with home testing, the epidemic curve of the coronavirus may not show the real burden of the disease. “Home tests are very convenient, but the onus is on the user to not become a source of infection for others by behaving carelessly,” says Lalit Kant, former head of epidemiology and communicable diseases at the ICMR.
So, if you test positive, inform the authorities. And if you test negative but have symptoms, take an RT-PCR test. Without fail.
@neetu_csharma
