- The FDA authorizes the emergency use of Roche's (OTCQX:RHHBY +1.9%) Elecsys Anti-SARS-CoV-2 antibody blood test, a semi-quantitative assay that measures the levels of antibodies to the spike protein of the coronavirus.
- Compared to results from a molecular test, the negative concordance rate (percent agreement) is 99.98% and the positive concordance rate is 96.6% [at least 15 days after diagnosis with a polymerase chain reaction (PCR) test].
- Results can be generated in ~18 minutes when performed on the company's automated cobas e analyzers.
- The test is the seventh member of its line-up of COVID-19 diagnostics.
- Shipments will begin next week.
- https://seekingalpha.com/news/3640440-fda-oks-emergency-use-of-roche-test-measures-anti-sars-covminus-2-antibody-levels
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