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LumiraDx Achieves CE Mark for Its High Sensitivity, High Throughput COVID-19 Molecular Test, RNA STAR Complete
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LumiraDx High Sensitivity Point of Care Antigen Test Detects Against Leading Variants of Concern including Alpha, Beta, Gamma, and Delta
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LumiraDx Announces Commercial Launch of its SARS-CoV-2 Ag Pool Test in CE Mark countries
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LONDON, Jan. 21, 2021 /PRNewswire/ LumiraDx, the next-generation point-of-care diagnostic testing company, announced today multinational approvals of its SARS-CoV-2 Antigen Test. With approvals in Japan and Brazil, the fast, accurate LumiraDx SARS-CoV-2 Antigen Test is now available to patients in more than 30 nations worldwide. In addition to these authorizations, the Italian Association for Clinical Microbiology recently published testing guidelines favorable to next-generation microfluidic technology – like LumiraDx s – for COVID-19 testing.
The LumiraDx SARS-CoV-2 Antigen Test is a microfluidic immunofluorescence assay designed to detect SARS-CoV-2 antigen in nasal or nasopharyngeal swab specimens, with high sensitivity results in 12 minutes from sample application.
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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.