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Finnish Diagnostic Firm Actim Gets CE Mark for SARS-CoV-2 Antibody Test

NEW YORK – Finnish diagnostics company Actim said on Tuesday it has received CE marking for the Actim ELISA SARS-CoV-2 IgG assay.

The test, which uses serum samples, provides semiquantitative detection of antibodies against SARS-CoV-2, allowing for the identification of patients who may have had the coronavirus. The assay has 96 percent sensitivity and 98 percent specificity, Actim said, adding it does not cross-react with IgG antibodies against other common viruses such as influenza A/B.

Up to 80 patient samples can be tested simultaneously with the assay and semiquantitative results can be achieved in less than two hours, the company, which is part of Finnish biotechnology group Medix Biochemica, said.