In a major breakthrough in the global fight against coronavirus, Abbott Laboratories announced today, that it has received Emergency Use Authorization (EUA) from the US FDA for a new COVID-19 test that can give results within minutes. This new test, based on the company’s ID NOW platform, can return a COVID-19 positive result in 5 minutes and a negative result in 13 minutes.
Currently, most test kits being used globally take at least a couple of hours to give results. Previously too, companies have come out with new tests that have significantly reduced times. But Abbott’s test will be the first to make a COVID-19 test truly rapid, and practically scalable to the scale of millions.
And it isn’t just the time that is of advantage here. These tests are carried out in small, portable machines, which can be taken to almost any location globally. The ID NOW-based COVID 19 test platform is small, weighs just about 6.6 pounds and highly portable , and uses molecular technology. Physicians and medical professionals highly recommend testing through molecular tech, since the results are far more accurate than other traditional methods.
Molecular testing helps detect the presence of a virus by identifying a small section of the virus’ genome, then amplifying that portion until there’s enough for detection. This process can cut testing wait time from hours, to as little as five minutes for positive results and 13 minutes for negative results.
The test, like most usual coronavirus tests, begins with by taking a swab from the nose or the back of the throat. The collected sample is then mixed with a chemical solution that can break the virus to single out its RNA. This prepared sample is then inserted into Abbott’s ID NOW platform, which then amplifies and enhances the sample, until it is clear enough for detection.
“The COVID-19 pandemic will be fought on multiple fronts, and a portable molecular test that offers results in minutes adds to the broad range of diagnostic solutions needed to combat this virus,” said Robert B. Ford, president and chief operating officer, Abbott. “With rapid testing on ID NOW, healthcare providers can perform molecular point-of-care testing outside the traditional four walls of a hospital in outbreak hotspots.”
The ID NOW platform is already the most used testing platform across the US, with over 18,000 such devices already in use. It is widely used to detect influenza, strep throat and respiratory syncytial virus, a common bug that causes cold-like symptoms.
In terms of capacity, the pharma major plans to supply 50,000 tests a day starting April 1, said John Frels, vice president of research and development at Abbott Diagnostics. These will currently be deployed across the US. There is no definite timeline on a global roll out.
Apart from this ID NOW-powered test, Abbott announced last week, availability of the Abbott RealTime SARS-CoV-2 EUA test under FDA EUA (Emergency Use Authorization), which runs on m2000 RealTime molecular system for centralized lab environments. Combined with ID NOW, Abbott expects to produce about 5 million tests in April, making it by far, one of the single biggest coronavirus test producers globally.
Similar efforts to speed up coronavirus testing are happening globally, by both traditional pharma companies and new-age health-tech startups. WHO recommends intensive testing and tracing out of cases as the only way to significantly contain the spread. Recently, India-based Mylabs became the first private company to make Indian drug regulator CDSCO-approved test kits in the country. Mylabs’ test kits significantly reduce testing time from the current 4 hours to 2. The company also said that it can produce close to 100,000 tests in a week, significantly increase testing capacity in the world’s second most populous country.