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Reliable quantification of the antibody response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is highly relevant, e.g., for identifying possible vaccine failure and estimating the time of protection. Nonetheless, rapid antigen testing quickly identifies positive among those with symptoms and/or close contact exposure and could expedite isolation and treatment.
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BinaxNOW has high accuracy among symptomatic individuals and is below the FDA threshold for emergency use authorization in asymptomatic individuals. Specificity was greater than 99% for all groups. Sensitivity was 82% (95% CI 66%, 91%) for asymptomatic individuals with potential exposure and 64% (95% CI 51%, 76%) for those with no exposure. It was higher in symptomatic (87% 95% CI 80%, 91%) than asymptomatic (71% 95% CI 61%, 80%) individuals. Overall test sensitivity compared with reference laboratory reverse-transcription PCR testing was 81% (95% confidence interval 75%, 86%). Most (89%) were asymptomatic, of whom 17% reported potential exposure. Participants were grouped by self-reported COVID-19 exposure and symptom status. We describe our implementation and assess performance of the BinaxNOW COVID-19 Antigen Test (Abbott Laboratories) in 6,099 adults at a self-referred walk-up testing site. Rapid antigen tests are simple to perform and provide results within 15 min.