Atlas-Link Technology Co., Ltd.

INTENDED USE:

This kit is used for in vitro rapid qualitative detection of novel coronavirus (SARS-CoV-2) antigens in pharyngeal and nasal swab samples. The product is designed to be used for population screening early phase for disease outbreaks. Testing is limited to laboratories certified. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. 

SARS-CoV-2 Antigen Rapid Test Kit provides preliminary test results, with negative results don’t preclude SARS-CoV-2 infection. Cannot be used as the sole basis for treatment or other management decision. For in vitro diagnostic use only.

SUMMARY AND EXPLANATION:

Novel coronavirus pneumonia (Coronavirus disease 19, COVID-19) is an infectious disease caused by SARS- CoV-2 infection. On February 11, 2020 the International Committee for Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2.Its clinical manifestations contain fever, fatigue, and dry cough. A few patients have nasal congestion, runny nose, and sore throat and diarrhea and other symptoms. In severe cases, dyspnea and / or hypoxemia usually occurs after one week. Some critical patients show distress syndrome, septic shock, metabolic acidosis that is difficult to correct, and rapidly develop coagulopathy.

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