Celltrion DiaTrust™ COVID-19 Ag Home Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein and receptor binding domain (RBD) of the SARS-CoV-2 spike proteins in mid-turbinate swabs from the SARS-CoV-2. This test is authorized for non-prescription home use with self-collected and adult-collected direct mid-turbinate swab samplesfrom individuals aged 14 years or older with symptoms of COVID-19 within the first seven days of symptom onset. This test is also authorized for non-prescription home use with self-collected and adult-collected mid-turbinate swab samples from individual 14 years or older with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.
