PerkinElmer Receives FDA Emergency Nod For Respiratory SARS-CoV-2 Panel

(RTTNews) - PerkinElmer Inc. (PKI) said Thursday that it has received an emergency use authorization from the U.S. Food and Drug Administration for the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.

The company noted that laboratories can immediately begin using the single test for the 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 said a multi-analyte test such as the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay allows laboratories to conserve precious resources by avoiding multiple tests on samples collected from individuals suspected of respiratory viral infection consistent with COVID-19.

PerkinElmer also has CE marking for a multi-analyte respiratory panel that tests for COVID-19 - the PKamp Respiratory SARS-CoV-2 RT-PCR Panel assay has clearance to be marketed as an in vitro diagnostic device in more than 30 countries by meeting the requirements of the European In Vitro Diagnostic Directive.