This test kit for the novel coronavirus causing the current pandemic around the global community will be a celebration for millions.
USA, CHICAGO – A new Corona Virus testing toaster like approved by FDA. The point-of-care kit coronavirus testing equipment could be ready by next week.
The U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization to the company based in Illinois named Abbott Labs on Friday. The test is expected to give positive results under five minutes and negative results in 13 minutes according to information monitored from the company.
“I am pleased that the FDA authorized Abbott’s point-of-care test yesterday. This is big news and will help get more of these tests out in the field rapidly,” FDA Commissioner Steve Hahn said in a statement. “We know how important it is to get point-of-care tests out in the field quickly. These tests that can give results quickly can be a game changer in diagnosing COVID-19.”
The company plans to roll out manufacturing upto 50,000 test units per day.
The new Abbott ID NOW COVID-19 test uses the Abbott ID NOW diagnostics platform, which is essentially a lab-in-a-box that is roughly the size of a small kitchen appliance. Its size and that it can produce either a positive result in just five minutes or a negative one in under 15 mean that it could be a very useful means to extend coronavirus testing beyond its current availability to more places including clinics and doctor’s offices, and cut down on wait times both in terms of getting tested and receiving a diagnosis.
Unlike the rapid tests that have been used in other countries, and that under an FDA guideline that doesn’t confirm the accuracy of the results, this rapid testing solution uses the molecular testing method, which works with saliva and mucus samples swabbed from a patient. This means that it works by identifying a portion of the virus’s DNA in a patient, which means it’s much better at detecting the actual presence of the virus during infection, whereas other tests that search the blood for antibodies that are used in point-of-care settings can only detect antibodies, which might be present in recovered patients who don’t actively have the virus.
The good news for availability of this test is that ID NOW, the hardware from Abbott that it runs on, already “holds the largest molecular point-of-care footprint in the U.S.,” and is “widely available” across doctor’s offices, urgent care clinics, emergency rooms and other medical facilities.
In total, Abbott now says that it believes it will produce 5 million tests in April, split between these new rapid tests and the lab tests that it received emergency use authorization for by the FDA on March 18.
Testing has been one of the early problems faced by the U.S. in terms of getting a handle on the coronavirus pandemic: The country has lagged behind other nations globally in terms of per capita tests conducted, which experts say has hampered its ability to properly track and trace the spread of the virus and its resulting respiratory disease. Patients have reported having to go to extreme lengths to receive a test, and endure long waits for results, even in cases where exposure was likely and their symptoms match the COVID-19 profile.
Additions from UT and TV.