COVID19 In Vitro Diagnostic Devices and Test Methods Database. Home; COVID-19 In Vitro COVID-19 In Vitro Diagnostic Medical Device - detail. ENCODE SARS-COV-2 Antigen rapid Test Device. Manufactured by Zhuhai Encode Medical Engineering Co. Ltd., China - http// SARS-CoV. Lineages detected. B.1.1.7 (Alpha),
BackgroundPCR testing is considered the gold standard for SARS-CoV-2 diagnosis but its results are earliest available hours to days after testing. Rapid antigen tests represent a diagnostic tool enabling testing at the point of care. Rapid antigen tests have mostly been validated by the manufacturer or in controlled laboratory settings only.
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