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Roche Diagnostics Deutschland GmbH Sandhofer Str. 116 68309 Mannheim, Germany http://www.roche.de/
Contact Ms Maren Schulz +49 621 7595484
Company logo of Roche Diagnostics Deutschland GmbH
Roche Diagnostics Deutschland GmbH

COVID-19-Antikörpertest von Roche erhält von US-amerikanischer FDA die Genehmigung zur Verwendung in Notfallsituationen

FDA-Zulassung ergänzt die bereits Ende April erfolgte CE-Kennzeichnung

(PresseBox) (Mannheim, )
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- Serologischer Test mit einer Spezifität von mehr als 99,8% und Sensitivität von 100% (14 Tage nach bestätigter Infektion mittels PCR)

- Hohe Spezifität des Tests ist entscheidend, um zuverlässig festzustellen, ob ein Patient Kontakt zum Virus hatte und ob er entsprechend Antikörper dagegen entwickelt hat

- In Ländern, in denen die CE-Kennzeichnung1 anerkannt wird, sowie in den USA im Rahmen einer Genehmigung zur Verwendung in Notfallsituationen wird Roche Tests in hoher zweistelliger Millionenzahl bereitstellen können, eine weitere Erhöhung der Kapazitäten ist bereits in Vorbereitung

- Test kann auf den weltweit verbreitet und in Deutschland flächendeckend verfügbaren xdgggxmslzffxfi Npeae-Dugxpnzwbxlrdi ulv Aoaji xgkpv r uzvvsbitbiev ectqct

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