EU gives CE mark approval to SARS-CoV-2 (COVID-19) antibody microarray test as a diagnostic for COVID-19.- Quotient

Quotient announced that it has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE marked its SARS-CoV-2 (COVID-19) antibody microarray. The test is now available for sale in Europe and Switzerland. In one patient, the antibody negative status changed to positive one day after the PCR positive result, and in another patient, the antibody negative status changed to positive four days post PCR result. This demonstrates that the MosaiQ antibody test can detect antibodies very early in seroconversion process.

The MosaiQ COVID-19 Antibody Microarray is designed as a serological disease screen specific to COVID-19. The assay detects the IgG and IgM antibodies directed at SARS-CoV-2. In addition to the concordance studies, the Company observed seroconversions (the generation of antibodies specific to SARS-CoV-2) in two patients where diagnosis was supported by a polymerase chain reaction (PCR) assay on the patients at the time of symptoms.