The PKamp Respiratory SARS-CoV-2 RT-PCR Panel from PerkinElmer, Waltham, Mass, 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 (IVDD). This test is currently under review for FDA emergency use authorization.
The multianalyte 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. The multianalyte panel is designed to be used with PerkinElmer’s automated viral nucleic extractor to detect smaller amounts of viral material in samples.
“In the next few months, it will be vital for health professionals to detect and differentiate between COVID-19, the common flu and RSV infection,” says Masoud Toloue, PhD, vice president and general manager, diagnostics, PerkinElmer. “By offering an automated multi-analyte testing solution, we are equipping diagnostics labs with the right toolset to tackle the additional pressure the season may have on this pandemic.”
For more information, visit PerkinElmer.
Featured image: Colorized scanning electron micrograph of an apoptotic cell (green) infected with SARS-COV-2 virus particles (orange), isolated from a patient sample. Image captured at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland. Credit: NIAID.