Therapy Areas: Respiratory
PerkinElmer Receives FDA Emergency Use Authorization for Respiratory SARS-CoV-2 Panel
7 October 2021 - - The US Food and Drug Administration has issued Emergency Use Authorization for the PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay, US-based PerkinElmer, Inc. (NYSE: PKI) said.

Qualified laboratories can immediately begin using this 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.

COVID-19, flu and RSV infections are highly contagious and often cannot be differentiated based on symptoms alone.

The US Centers for Disease Control and Prevention encourages COVID-19 testing laboratories to adopt a multiplex method that facilitates detection and differentiation of SARS-CoV-2 and influenza viruses.

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.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 USC. § 263a, that meet requirements to perform high complexity tests.

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.

PerkinElmer's comprehensive 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.


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