FDA approves tests to measure SARS-CoV-2 antibodies

United States // 01 August, 2020

The FDA has announced that they have authorised two coronavirus tests which can measure SARS-CoV-2 antibodies. These are the first antibody tests to be authorised by the FDA which can not only detect but also measure the estimated level of SARS-CoV-2 antibodies. Both the tests, the ADVIA Centaur COV2G and Attelica COV2G, are developed by Siemens. “The FDA also wants to remind patients that serology tests should not be used to diagnose an active infection, as they only detect antibodies the immune system develops in response to the virus – not the virus itself”.  For more information view the FDA announcement.

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FDA APPROVES ANTIBODY BLOOD TEST
Posted: 03 May 2020 - Antibody tests analyze samples taken from people who may have had a COVID-19 infection and recovered. (Antibodies are the immune system's response to the virus.) These tests cannot yet be used as evidence of immunity to COVID-19, since there is not adequate data yet to determine whether a prior infection protects people from a future one. These tests can, however, greatly help in public health initiatives, such as determining how many people in an area have been infected - especially since some COVID-19 cases never show symptoms. A test developed by Roche pharmaceuticals has been given emergency FDA approval after showing more than 99 percent accuracy in initial testing results. (Its specificity, or ability to rule out antibodies if there are not present, is greater than 99.8 percent. That means it is unlikely to tell people they have antibodies when they actually don't. The test's accuracy, or ability to detect antibodies when they actually are present, is 100 percent. This means people who are told they have antibodies, based on this test, actually do have them.) The company states, with their global manufacturing capabilities, they will be able to produce high double-digit millions of tests per month.



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