A US-based laboratory received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for molecular point-of-care test to detect COVID-19. After the approval, Abbott laboratories has launched its molecular point-of-care test that delivers positive COVID-19 results in as little as 5 minutes and negative results in 13 minutes.
The company, in a statement, said that it will be making ID NOW, a portable instrument that can be deployed where testing is needed most, COVID-19 tests available next week and expects to ramp up manufacturing to deliver 50,000 tests per day. It is the company’s second test after Abbott RealTime SARS-CoV-2 EUA to receive EUA by the FDA for COVID-19 detection and expects to produce about 5 million tests per month combined.’
This is GAME CHANGER. Abbott to market, starting next week, a fast point-of-care #coronavirus test, delivering positive results in 5min and negative results in 13min. Will deliver 50K tests/day to start. Kudos to Abbott and FDA’s Jeff Shuren and team at CDRH who are in the fight.— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
It’s very likely that we’ll see additional approvals of POC diagnostics behind this one, extending testing to doctor offices across the U.S.— Scott Gottlieb, MD (@ScottGottliebMD) March 28, 2020
For the test, an upper respiratory tract swab collects a mucus sample for testing and the sample is mixed with reagents that break open the virus and release its genetic material, the viral RNA. The reagents then recognise a unique section of the coronavirus genome while ignoring other viruses even if they are similar strains.
The virus genome is replicated from a few target molecules up to a billion, making the virus more detectable and then the molecular test provides results to the healthcare provider. “Through the incredible work of teams across Abbott, we expect to deliver 50,000 COVID-19 tests per day to healthcare professionals on the front lines, where testing capabilities are needed most," said Chris Scoggins, senior vice president, Rapid Diagnostics, Abbott.