OHC COVID-19 Antigen Self Test User Instructions For Emergency Use Authorization (EUA) Only. For In vitro diagnostic use. In the USA, this product has not been FDA cleared or approved;
COVID-19 based on a viral test result. The test result may be from a NAAT/PCR or an antigen test. The definition includes staff with an NHSN defined re -infection. Note: Exclude staff and facility personnel who have a positive SARS-CoV-2 antigen test, but a negative SARS-CoV-2 NAAT (PCR).
To increase the accuracy of an at-home COVID-19 antigen diagnostic test, it is important to perform repeat testing, after 48 hours, following a negative test result, whether you have symptoms or
The BinaxNOWâ„¢ COVID-19 Antigen Self Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 15 years or older or adult collected anterior nasal
That means, "the point of an antigen test is to detect the presence of a protein—the nucleocapsid protein—which is part of the SARS-CoV-2 virus that is the cause of COVID-19," said Dr. Shaw.
The performance of the Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients.
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covid 19 antigen test instructions