COVID-19 Ag/Ab Sealing Tube Twin Test Strip (Colloidal Gold) INTENDED USE: Amazing COVID-19 Ag/Ab Sealing Tube Twin Test Strip is a lateral flow immuno- chromatographic assay for the simultaneous rapid in vitro differential detection of COVID-19 nucleocapsid protein antigen and COVID-19 antibody (IgG/IgM). The kit has two strips. One strip is for the qualitative detection of COVID-19 nucleocapsid protein antigen in human nasopharyngeal, nasal secretion, saliva or/and serum specimens directly collected from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Another strip is for the qualitative detection of COVID-19 antibody(IgG/IgM) in human serum, plasma (sodium citrate, sodium heparin, dipotassium EDTA), and whole blood (sodium citrate, sodium heparin, dipotassium EDTA or fingerstick whole blood) to aid identifying individuals with an adaptive immune response to COVID-19, indicating recent or prior infection and patients with suspected COVID-19 infection in conjunction with clinical presentation and the results of other laboratory tests. Results from the Amazing COVID-19 Ag/Ab(IgG/IgM) Sealing Tube Twin Test Strip should not be used as the sole basis for diagnosis. The kit is assistance for diagnostic and epidemiological investigation. These two strips are in the sealing tube to avoid potential biosecurity substances such as coronavirus from clinical samples, which will much help to avoid pathogen contamination and spreading to the operator and its environment. The kit is intended for use by medical professionals or trained operators who are proficient in performing tests and trained clinical laboratory personnel or individuals trained in point of care settings.