The COVID-19 Antigen Rapid Test Kit (Short Nose) is an immunochromatographic Assay intended for the direct and qualitative detection of SARS-CoV-2 nucleocapsid antigens in Nasal swab from individuals who are suspected of COVID-19 symptoms. The COVID-19 Antigen Rapid Test Kit (Short Nose) is suitable for testing in both asymptomatic and symptomatic individuals from aged 18 years old and older. The test is to be used as an aid in the diagnosis of coronavirus infection disease (COVID-19), which is caused by SARS-CoV-2. The COVID-19 Antigen Rapid Test Kit(Short Nose) does not differentiate between SARS-CoV and SARS-CoV-2. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimen during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions.
