Shenzhen Uni-medica  2019 new virus Antigen Test cassette is a gold immuno-chromatographic assay (GICA) that is intended for the qualitative detection of the specific protein antigen from virus in nasopharyngeal (NP) swab, nasal (NS) swab, and saliva specimens directly from individuals who are suspected of 2019 new virus disease by their healthcare provider, with or without signs and symptoms of 2019 new virus disease. It can be used easily for self test at home or for professional test by a medical staff.

This rapid antigen test cassette has been granted CE certificate and registered in China White list of Export. It has been exported and widely used in many countries.

The 2019 new virus disease is spread by human-to-human transmission and infection has been estimated to have a mean incubation period of 6.4 days and a basic reproduction number is 2.24-3.58. Many countries in the world have recognized the value of antigen detection in the early diagnosis of 2019 new virus infection.

Test results are for the identification of virus  nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens 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. Positive results do not rule out bacterial infection or co-infection with other viruses. 
Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out 2019 new virus disease  and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with 2019 new virus disease. 

This  20T/kit package is specially for use by clinical unity.