cobas® SARS-CoV | 合法醫療器材資訊網

cobas®SARS-CoV-2&InfluenzaA/BisintendedforuseasanaidinthedifferentialdiagnosisofSARS-CoV-2,influenzaA,andinfluenzaBinhumansandisnot ...

* cobas® SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas® 5800/6800/8800 Systems (package Insert), Pleasanton, CA, Roche Molecular Systems, Inc. 2020

** compared to highly sensitive CE-IVD assays, one comparator for SARS-CoV-2 and another for Influenza A/B

a discordant results for SARS-CoV-2 are from samples of recovery/convalescent patients with increasing viral loads close to or below the LOD of both tests

b based on co-formulated, combined lot performance

c first WHO International Standard for SARS-CoV-2

d one TCID50/mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA 1/2020, infectious culture, Cat No NR-52281, Lot 70033175)