CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Oct. 13, 2021—PerkinElmer announced that the FDA has issued emergency use authorization for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay. The test provides simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus isolated from nasopharyngeal swabs, anterior nasal swabs, and mid-turbinate swabs.
The company announced in a separate release that its subsidiary Euroimmun received an EUA for its Anti-SARS-CoV-2 S1 Curve ELISA (IgG). The assay allows for the qualitative and semiquantitative detection of IgG antibodies formed against the SARS-CoV-2 S1 antigen, in human serum and plasma. The product measures the concentration of antibodies against the S1 domain of the spike protein, including the receptor binding domain. The assay can run manually or using the EuroLab Workstation ELISA, Sprinter XL, and third-party ELISA platforms.