Governments, businesses and individuals are looking for such blood tests to help them learn more about who may have had the disease, who may have some immunity, and to possibly develop strategies to end the blockages that have hit economies. worldwide.
Roche previously pledged to make its antibody test available in early May and increase production by June to “double-digit millions” per month.
The Basel-based company, which also performs separate molecular tests to identify people infected with Covid-19, said its antibody test, Elecsys Anti-SARS-CoV-2, has a specificity rate of around 99 , 8% and a sensitivity rate of 100%. .
These rates help determine if a patient has been exposed to Covid-19, the respiratory disease caused by the coronavirus, and if the patient has developed antibodies against it.
Other companies, including Abbott Laboratories in the United States, Becton Dickinson and Co, and DiaSorin in Italy, have also developed tests to identify antibodies that develop after a person comes into contact with the drug. virus.
DiaSorin and Abbott recently received US emergency clearance for their tests.
Countries have various plans to use these tests to better understand Covid-19, while also identifying those who have been infected but have shown mild or no symptoms.
A false false positive result could lead to the false conclusion that someone has immunity.
During the development of its test, Roche examined the reliability of certain existing products before rejecting them, had said earlier its general manager, Severin Schwan.
Schwan said there are about 100 such tests offered, including finger prick tests that provide a quick result.
He declined to specify the competing tests he had studied, but said he was not referring to tests performed by established test companies.
Roche said his antibody test requires an intravenous blood test to determine the presence of antibodies, including immunoglobulin G (IgG), which stays longer in the human body, suggesting possible immunity .
As demand for blood antibody tests intensifies, a range of distributors with no established medical testing experience or skill have joined experienced companies in an unregulated U.S. market, Reuters survey finds .
The rush to obtain, advertise and find buyers for the test kits follows the FDA’s decision to allow any company to sell antibody tests in the country without prior review by the agency.
It comes after the agency was criticized for not acting quickly enough with diagnostic tests.
The FDA has stated that the objective of its policy is to provide laboratories and healthcare providers with rapid access to testing, but that it will adjust the approach as necessary.