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Euroimmun SARS-CoV-2, Influenza A/B Test Gets CE Mark

NEW YORK – PerkinElmer's subsidiary Euroimmun announced on Monday it has received the CE mark for its EuroRealTime SARS-CoV-2/Influenza A/B PCR test for the direct detection of SARS-CoV-2 and influenza virus types A and B.

The company said it has launched the test in countries accepting the CE designation.

The test is for the detection and differentiation of genetic material from the coronavirus and influenza A/B. It uses a throat swab sample of patients with acute symptoms and is compatible with common real-time PCR thermal cyclers. Euroimmun said that validation efforts demonstrated "very high agreement" between results obtained with the EuroRealTime test and those obtained with reference PCR tests for SARS-CoV-2 and influenza A/B. The Lübeck, Germany-based company added that no cross-reactions with other common respiratory pathogens were detected.