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LONDON, Jan. 13, 2021 /PRNewswire/ LumiraDx, the next generation point-of-care diagnostic company, announced today that the Scandinavian evaluation of laboratory equipment for point of care testing (SKUP) had published a positive evaluation of the LumiraDx SARS-CoV-2 Antigen Test. In a mixed population of symptomatic and asymptomatic subjects tested in point of care settings, the test achieved 87-90% agreement with RT-PCR which increased to 92-95% in patients with viral load corresponding to Ct below 33. A significant body of evidence now suggests that individuals with high Ct values (low viral loads), such as above 33, are likely not infectious. Test specificity was 99.5% in nasal swab specimens.
LumiraDx erhält die Zulassung des Schweizer Bundesamtes für Gesundheit für seinen mikrofluidischen Antigentest mit RT-PCR für Point of Care COVID-19-Tests
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LumiraDx Receives Authorization by Switzerland´s Federal Office of Public Health Showing Excellent Positive Agreement of its Microfluidic Antigen | ANP Pers Support
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LONDON, Dec. 21, 2020 /PRNewswire/ LumiraDx, the next generation point-of-care diagnostic company, announced today that it has received Switzerland Federal Office of Public Health (FOPH) Authorization for the LumiraDx SARS-CoV-2 Antigen Test, following a positive technical validation conducted by the Swiss Society for Microbiology (SSM). The test achieved 98.4-100% positive agreement and 99% negative agreement compared to RT-PCR.
The LumiraDx SARS-CoV-2 Antigen Test is to be used with the LumiraDx Platform and detects antigen nucleocapsid protein from nasal or nasopharyngeal swabs with accurate qualitative results in 12 minutes. It uses next generation microfluidic immunofluorescence technology to deliver high sensitivity.