Specificity greater than 99.8%! Roche's new coronary serological testing reagent sedited by FDA for emergency use

Roche has begun shipping the new antibody testing reagent storts to laboratories around the world and will increase its production capacity to support up to tens of millions of tests per month to serve CE-labeled countries and U.Shealth care systemsRoche will provide up to 10 million tests in May for countries that receive CE labels, and in the United States will further increase production capacity under the Emergency Use Authorization (EUA)This test is available on Roche's copase analyzer, which is widely used around the world"Thanks to the tremendous efforts of our dedicated colleagues, we are now able to provide a large number of high-quality antibody tests, so that we can provide an important tool for healthcare systems around the world to better respond to the COVID-19 health crisis," said Severin Schwan, Ceo of Roche GroupI am particularly pleased that our tests are highly specific and sensitive, which is critical to supporting health care systems around the world and providing a reliable tool to better respond to the COVID-19 health crisisantibody testsantibody tests, also known as serological tests, to determine whether a person has acquired immunity to pathogensIn the case of a COVID-19 pandemic, antibody testing needs to be able to specifically detect anti-neoviral antibodies without cross-reaction with other similar coronaviruses, which may produce false positive results that incorrectly indicate potential immunityReducing false positive results is especially important when we do not know how many people in a particular population have COVID-19As of April 24, 2020, no studies have assessed whether the presence of anti-neoviral antibodies makes the body immune to subsequent infections of the viruson the Elecsys Anti-SARS-CoV-2 Serology Test
Elecsys® Anti-SARS-CoV-2 is an in vitro qualitative test for the immuno-analysis of neo-coronavirus antibodies (including IgG) in human serum and plasmaThe results of the test of 5,272 samples showed that the specificity of the Anti-SARS-CoV-2 test in elecsys ® was 99.81%, with no cross-reaction with 4 cold virusesThis means that it reduces the chance of false positives due to detection of similar antibodies that may exist in individualsElecsys ® Anti-SARS-CoV-2 detection sensitivity of 100% in samples taken 14 days after nucleic acid testing confirmed infectionhospitals and reference laboratories can be tested with Roche's cobase analyzers, which are widely used around the world These fully automated systems can deliver test results for a single test in approximately 18 minutes, with some analyzers performing up to 300 tests per hour References: s1 s roche's COVID-19 antibody test receives FDA Emergency Use authorization and is in marketing the CE mark Retrieved 2020-05-03, from http://