Atlas-Link Technology Co., Ltd.

INTENDED USE:

This kit is used for in vitro rapid qualitative detection of novel coronavirus (SARS-CoV-2) and influenza A+B antigens in nasopharyngeal 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 and influenza A and influenza B antigen. This antigen is generally detectable in upper
respiratory samples during the acute phase of infection.

NOVA Test®SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit provides preliminary test results, with negative results don’t preclude SARS-CoV-2 or influenza infection. Can not 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.

Influenza is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease easily transmitted from person to person through aerosol droplets excreted when sneezing and coughing. Common symptoms include high fever, chills, headache, cough, sore throat and malaise. Influenza A virus is more prevalent and is the primary pathogen associated with serious epidemics. Influenza B virus causes a disease that is generally not as severe as that caused by the type A virus. Both type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season. Early differential diagnosis of influenza type A or type B can allow for proper treatment with appropriate antiviral therapy while reducing the incidence of inappropriate treatment with antibiotics. Early diagnosis and treatment are of particular value in a clinical setting where accurate diagnosis can assist the healthcare professional with management of influenza patients who are at risk for complications. NOVA Test®SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit is a rapid immunoassay to be used as an aid for the differential diagnosis of influenza type A and type B.

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