INTENDED USE

SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) is intended for the qualitative detection of SARS-CoV-2 Antigen (Nucleocapsid protein) in nasal swab specimens in vitro. The positive results indicate the existence of SARS-CoV-2 antigen. It should be further diagnosed by combining the patient’s history and other diagnostic information . The positive results do not exclude bacterial infection or other viral infection. Pathogens detected are not necessarily the main cause of disease symptoms. The negative results do not exclude SARS-CoV-2 infection, and should not be the only basis for treatment or patient management decisions (including infection control decisions). Pay attention to the patient’s recent contact history, medical history and the same signs and symptoms of COVID-19, if necessary, it is recommended to confirm these samples by PCR test for patient management. It is for laboratory personnel who have received professional guidance or training and have professional knowledge of in vitro diagnosis, also for relevant personnel who have received infection control or nursing training.

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