Roche announced that it has developed a test aimed at uncovering the presence of antibodies against SARS-CoV-2. In a press release, Roche states that the company is endeavoring to have this test available on the market by the start of May.
This is, however, on the condition that countries accept the CE mark. According to an EU Regulation, the focus here is on manufacturers labelling the products themselves. In so doing, the manufacturer is expressly stating that the company is aware of the particular requirements incumbent on the products it sells and that it has complied with these. Roche is currently engaged in negotiations with the US Food and Drug Administration (FDA) with regard to an Emergency Use Authorization. Back in mid-March, Roche obtained an Emergency Use Authorization from the FDA to expedite virus testing.
In the new antibody test, human serum and plasma obtained from a blood sample are used. According to information in the press release, hospital and reference laboratories can use Roche devices to conduct the test, and these are widely available around the world.
Antibody testing is of vital importance in order to identify people who were infected with the virus but displayed no symptoms, the press release explains. With a “certain level of immunity”, high-risk groups in the healthcare sector or food supply workers, for example, could continue working or return to work.
“Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic”, comments Severin Schwan, CEO of Roche Group, in the press release. “Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally”.