A new antibody test from pharmaceutical giant Roche Holding AG was cleared by The Food and Drug Administration for use in the US.
The urgent “all-clear” from the FDA comes as no surprise since, until now, the Roche antibody test has been used under the table even by celebrities like Joe Rogan who utilized the test on his podcast guests.
The FDA clearance aids the efforts on US soil to determine the spread level of Covid-19. The test identifies the antibodies made by the immune system to fight off the coronavirus and is meant to tell people whether they have been infected in the past.
It is able to determine if any immunizers remain in the bloodstream after the infection, cells that can be detected weeks, months, or even years after the infection. The Roche antibody tests are said to be more effective than the swab tests used to diagnose a current infection.
These tests are a key player in understanding the spread of mild and asymptomatic cases of coronavirus. At the moment, there are only 10 commercially available, but the FDA is pushing for emergency clearance for those that prove to be reliable in revealing the antibodies in the human body.
The company said that the test has proven 100% accurate in detecting the Covid-19 antibodies in the blood, and it’s 99.8% accurate in indicating the presence of those antibodies. That means that only two in every 1.000 samples lacking the antibodies would produce a “false positive” result.
More and more tests like these are pushed out and approved by the FDA to help governments, health workers and people to assess the rate with which the coronavirus is spreading. Roche’s SARS-CoV2 antibody test has 14 days post-PCR confirmation. The more we understand about how the immune system responds to the SARS-CoV-2, the more we can strive to better isolate the virus.