Abstract
The sensitivity of the BinaxNOW coronavirus disease 2019 (COVID-19) Ag Card test (BinaxNOW) was 51.6% among asymptomatic healthcare employees relative to real-time reverse transcriptase polymerase chain reaction (rRT-PCR). The odds of a positive BinaxNOW test decreased as cycle threshold value increased. BinaxNOW could facilitate rapid detection and isolation of asymptomatically infected persons in some settings while rRT-PCR results are pending.
Highlights
D BinaxNOW is a rapid point-of-care lateral flow immunoassay that detects SARS-CoV-2 nucleocapsid protein antigen
We describe the test performance of the BinaxNOW test relative to the PerkinElmer reverse transcriptase polymerase chain reaction (rRT-PCR) assay in the setting of a COVID-19 outbreak among hospital employees
Paired nasal swab testing of 2,339 employees revealed 152 persons who were positive for SARS-CoV-2 by rRT-PCR, 86 (56.6%) of whom were positive by BinaxNOW
Summary
D BinaxNOW is a rapid point-of-care lateral flow immunoassay that detects SARS-CoV-2 nucleocapsid protein antigen. The test was granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) on August 26, 2020, with intended use in persons with suspected COVID-19 within 7 days of symptom onset.. The test achieves 97.1% sensitivity and 98.5% specificity when used within 7 days of symptom onset.. A statement issued by the FDA indicated that the test can be used off-label in asymptomatic persons if highly sensitive tests (eg, rRT-PCR tests) are not feasible or if turn-around times are prolonged.. We report the diagnostic test characteristics of the BinaxNOW test relative to the PerkinElmer SARS-CoV-2 real-time RT-PCR test during a COVID-19 outbreak
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