Perkin Elmer said it has developed a PKamp Respiratory SARS-CoV-2 RT-PCR Panel, which is currently under review by the U.S. Food and Drug Association (FDA) for Emergency Use Authorization (EUA), according to a press release from the company.
The test has already received clearance to be marketed as an in vitro diagnostic (IVD) device in more than 30 countries by meeting the requirements of the European In Vitro Diagnostic Directive (IVD).
The multi-analyte panel enables labs to detect and differentiate between SARS-CoV-2, influenza A viruses, influenza B viruses and respiratory syncytial virus (RSV) in a single test, which will be critical to manage the surge in test demand during the flu season as the targeted pathogens have some similar signs and symptoms.
Rather than running multiple tests on samples, the PKamp Respiratory SARS-CoV-2 RT-PCR Panel is designed to conserve resources by testing a single nasopharyngeal, oropharyngeal or nasal swab sample collected from individuals suspected of respiratory viral infection consistent with COVID-19, the flu and RSV. Building off the most sensitive SARS-CoV-2 test kit in the market according to the FDA’s reference panel comparative data, the multi-analyte panel is designed to be used with PerkinElmer’s automated viral nucleic extractor to detect smaller amounts of viral material in samples.
