PerkinElmer’s EUROIMMUN Launches New CE Marked PCR Test to Differentiate Between COVID-19 and Flu

EUROIMMUN, a PerkinElmer, Inc. (Waltham, MA; USA) company, has launched the CE marked EURORealTime SARS-CoV-2/Influenza A/B for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B.

The launch expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. The test is available in countries accepting the CE mark.

The new EURORealTime test allows fast detection and differentiation of genetic material from SARS-CoV-2, influenza virus type A and influenza virus type B using throat swab samples of patients with acute symptoms, which can be indicative for COVID-19 or flu. Validation efforts revealed very high agreement of results obtained with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B. No cross-reactions with other common respiratory pathogens were detected. The assay is compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software allows for reliable and standardized evaluation of the test results.

The EURORealTime SARS-CoV-2/Influenza A/B assay adds to the Company’s broad product portfolio of COVID-19 diagnostics and is the second molecular assay for direct pathogen detection following the CE-marked and FDA-EUA approved EURORealTime SARS-CoV-2 assay. The EURORealTime SARS-CoV-2/Influenza A/B assay complements PerkinElmer’s PKamp Respiratory SARS-CoV-2 RT-PCR Panel that previously received the CE mark.

“As the flu season overlaps with the second wave of COVID-19, there is an increasing need to be able to quickly distinguish between SARS-CoV-2 and influenza infections. Individuals with these viral diseases can present with very similar symptoms which makes it difficult to differentiate between them. Here, direct pathogen detection plays a major role in rapid and correct identification of these infections as it is essential for proper subsequent patient management,” said Dr. Wolfgang Schlumberger, CEO of EUROIMMUN. “The combination of the three pathogens within this single multi-parametric assay means saving valuable time and resources in the laboratories.”