REF:

C2106 (Cassette)

INTENDED USE:

Influenza A/B Antigen Joint Test Kit employs Immunochromatography to detect influenza A and influenza B viral nucleoprotein antigens in direct nasopharyngeal swab from symptomatic patients.

This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens.

A negative test is presumptive and it is recommended these results be confirmed by viral culture or an CE-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. Testing is limited to professional and laboratory use.

For in vitro diagnostic use only.

SUMMARY:

Influenza viruses are causative agents of highly contagious, acute, viral infections of the respiratory tract. Influenza viruses are immunologically diverse, single-stranded RNA viruses. There are three types of influenza viruses: A, B, and C. Type A viruses are the most prevalent and are associated with most serious epidemics. Type B viruses usually lead to milder symptoms than type A and rarely cause epidemics. Type C viruses have never been associated with a large epidemic of human disease. Both Type A and B viruses can circulate simultaneously, but usually one type is dominant during a given season. People 65 years and older, people with chronic medical conditions (such as asthma, diabetes, or heart disease), pregnant women, and children younger than 5 years are at high risk for serious influenza complications.