SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit

Expected Use:

This kit is used for the rapid in vitro qualitative detection of novel coronavirus (SARS-CoV-2) and influenza A+B antigens in nasopharyngeal swab samples. The product is designed to be used in the initial phase of detecting disease outbreaks in the population. Testing is limited to certified laboratories.

The results are for the identification of SARS-CoV-2 nucleocapsid and influenza A and influenza B antigen. This antigen is generally detectable at the top respiratory samples during the acute phase of infection. The NOVA Test®SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit provides preliminary test results, with negative results that do not exclude SARS-CoV-2 or influenza infection. It cannot be used as the sole basis for treatment or other management decisions. 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 the Taxonomy of Viruses (ICTV) renamed the virus SARS-CoV-2. Its clinical manifestations include fever, fatigue and dry cough. Some patients have nasal congestion, runny nose, sore throat, diarrhoea, and other symptoms. In severe cases, dyspnea and/or hypoxemia are usually present within a week. Some critically ill patients develop distress syndrome, septic shock, metabolic acidosis that is difficult to correct, and coagulopathy rapidly.

Influenza is a highly contagious acute viral infection of the respiratory tract. It is a communicable disease that is easily transmitted from person to person through aerosol droplets excreted by sneezing and coughing. Common symptoms include high fever, chills, headache, cough, sore throat, and malaise. Influenza A virus is more prevalent and is the main pathogen associated with severe epidemics. Influenza B viruses cause illness that is generally not as severe as that caused by type A viruses. 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 may allow adequate treatment with appropriate antiviral therapy while reducing the incidence of inappropriate antibiotic treatment. Early diagnosis and treatment are of particular value in a clinical setting where an accurate diagnosis can help a healthcare professional manage influenza patients who are at risk of complications. NOVA Test®SARS-CoV-2/Influenza A+B Antigen Combo Rapid Test Kit is a rapid immunoassay used as an aid for the differential diagnosis of influenza type A and type B.