PerkinElmer company EUROIMMUN has secured CE mark approval for its new polymerase chain reaction (PCR) test to differentiate between Covid-19 and flu.
The EURORealTime SARS-CoV-2/Influenza A/B test has been approved for direct detection of SARS-CoV-2, influenza virus type A and influenza virus type B.
By using throat swab samples of patients with acute symptoms, the new EURORealTime test facilitates quick detection and differentiation of genetic material from SARS-CoV-2, influenza virus type A and influenza virus type B.
According to the company, validation efforts showed that high agreement of results with the EURORealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B.
EURORealTime assay compatible with common real-time PCR thermal cyclers
The assay is said to be compatible with common real-time PCR thermal cyclers, while the EURORealTime Analysis Software enables standardised evaluation of the test results.
The EURORealTime SARS-CoV-2/Influenza A/B assay is the second molecular assay for direct pathogen detection, while the first is the CE-marked and FDA-EUA approved EURORealTime SARS-CoV-2 assay.
According to the company, the new assay is an addition to PerkinElmer’s PKamp Respiratory SARS-CoV-2 RT-PCR Panel, which earlier secured the CE mark.
EUROIMMUN CEO Dr Wolfgang Schlumberger said: “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.”
In November this year, EUROIMMUN introduced the Anti-SARS-CoV-2 QuantiVac ELISA (IgG) test for the quantification of IgG antibodies against the SARS-CoV-2 S1 antigen.
