Dive Brief:
- Abbott on Monday announced the FDA granted emergency use authorization for a test meant to detect antibodies to the coronavirus that runs on its Alinity i immunoassay platform. The EUA marks the fourth for a test from Abbott addressing COVID-19 and its second focused on the IgG antibody.
- Late last month, the company's SARS-CoV-2 antibody test was greenlighted by the FDA to run on its Architect analyzers.
- Abbott said it intends to ship almost 30 million antibody tests worldwide in May across both platforms and contends it will have capacity for 60 million tests in June.
Dive Insight:
Like other serology tests, Abbott's is meant to help identify individuals infected with the virus who may have developed immunity. Its latest antibody test is designed to detect the IgG antibody, similar to its first antibody test that received an EUA last month.
Swiss diagnostics giant Roche got the nod last week from the agency for its antibody test and similarly plans to produce in the “high double-digit millions” of the kits this month. The Roche test also looks for IgG.
Abbott said Monday its newest SARS-CoV-2 IgG assay has specificity of 99.6%, indicating low likelihood of false positives,and sensitivity of 100%, suggesting improvement in not delivering false negatives, in patients tested 14 days after starting to show symptoms. By comparison, Roche's antibody test has specificity of 99.8% and sensitivity of 100%, when used on samples taken 14 days after the confirmation of infection.
Other major companies such as BD launched similar tests without the EUA designation under an earlier FDA policy. However, the agency last week toughened its requirements for coronavirus antibody tests amid questions about the accuracy of some tests already available that had not undergone agency review.
Another antibody, IgM, which Abbott's test is not able to detect, may signal more recent exposure. By comparison, BD's test is able to detect both IgG and IgM.
Regarding its latest test, Abbott said it is working with virology labs to validate testing results and is installing additional systems to help facilitate large-scale and reliable antibody testing worldwide.
Last month, Abbott received CE mark for its SARS-CoV-2 IgG antibody test on the Architect system and this week plans to submit the Alinity i SARS-CoV-2 IgG test for CE marking.
