PerkinElmer has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay.
The EUA status allows qualified laboratories to use the single test for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) isolated from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.
The PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay enables to avoid multiple tests on samples collected from individuals suspected of respiratory viral infection consistent with Covid-19, thereby helping to conserve important resources.
PerkinElmer specialty diagnostics managing director Arvind Kothandaraman said: “As we enter the flu season, this timely emergency use authorization will be welcome by laboratories that are looking to test for common respiratory illnesses alongside Covid-19.
“The new test will help to alleviate confusion arising from similar symptoms caused by these infections and reduce further strain on the healthcare system during a pandemic.”
PerkinElmer also has CE mark for a multi-analyte respiratory panel, which is used for Covid-19 testing.
The PKamp Respiratory SARS-CoV-2 RT-PCR Panel assay is approved for selling as an in vitro diagnostic (IVD) device in over 30 countries. It is in line with the requirements of the European In Vitro Diagnostic Directive (IVDD).
The US Centers for Disease Control and Prevention is said to encourage Covid-19 testing laboratories to adopt a multiplex method, which enables to detect and differentiate SARS-CoV-2 and influenza viruses.
PerkinElmer’s SARS-CoV-2 portfolio includes high throughput RNA extraction, RT-PCR, workflow automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based antigen as well as serology testing.
In May this year, PerkinElmer agreed to acquire UK-based IVD solutions provider Immunodiagnostic Systems Holdings (IDS) for around $155m.
