15 December 2020 | News
Receives CE Mark to use in the detection of SARS-CoV-2, influenza virus type A and influenza virus type B
Photo Credit: PerkinElmer
EUROIMMUN, a PerkinElmer, Inc. Company, has announced the launch of 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. It expands the testing portfolio for acute COVID-19 diagnostics by supporting differential diagnostics between SARS-CoV-2 infections and the common flu. It is available in countries accepting the CE mark.
PCR technology is considered the gold standard for direct pathogen detection. 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.
“Individuals with SARS-CoV-2 and influenza infections can present with very similar symptoms which makes it difficult to differentiate between them. Direct pathogen detection is essential for rapid and correct identification of these infections. The combination of the three pathogens within this single multiparametric assay saves time and resources in the laboratories,” says Dr. Wolfgang Schlumberger, CEO of EUROIMMUN.
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.