Swiss drug maker Roche Holding AG reports that it has been approved for emergency use by the US Food and Drug Administration (FDA) for an antibody check to help decide if individuals have ever become diagnosed with the coronavirus.
Governments, companies, and people are searching for blood samples of this sort that help them know more about who may have had the outbreak, who would have some tolerance, and possibly devise plans to break lock-downs that have disrupted global economies.
Roche is on the right path
Roche had previously promised to make available its antibody test by early May and to raise development to “mid double-digit million” a month by June.
The Basel-based firm, which also carries out separate molecular studies to classify people with active Covid-19 infections, said its antibody test, Elecsys Anti-SARS-CoV-2, had a specificity rate of approximately 99.8% and a sensitivity rate of 100%.
Such levels help to assess whether a patient has been exposed to Covid-19, the coronavirus-caused respiratory disease, and whether the patient has produced antibodies to it. Recently, DiaSorin and Abbott earned U.S. emergency monitoring permission.
Countries have various proposals to use these tests to better recognize Covid-19. Thus recognizing others that have caught the virus, but exhibited only slight symptoms, or zero.
An erroneous false-positive outcome may lead to the erroneous inference that someone has immunity.
Roche scrutinized some existing products for durability in designing its test before dismissing them. Its chief executive, Severin Schwan, had previously stated.
Other firms, including Abbott Laboratories in the US, Becton Dickinson and Co, and DiaSorin in Italy. They have already developed tests to recognize antibodies that form after someone has come into contact with the virus.
Schwan said about 100 such tests were on sale, including assays with finger pricks that give a fast outcome.
It refused to say which competitor studies it had been researching. But said it did not apply to studies from existing research firms.
Roche also confirmed that its antibody checks needs an intravenous blood sample. To assess the identity of antibodies to immunoglobulin G (IgG). Which lasts longer in the human body, indicating potential immunity.