Influenza A/B Rapid Test (Self-Testing)

A rapid chromatographic immunoassay for the qualitative and differential detection of Influenza virus type A and type B antigens directly from nasal swab specimens. For in vitro diagnostic use only. For self-testing.

INTENDED USE
The Influenza A/B Rapid Test (Self-Testing) is a rapid chromatographic immunoassay for the qualitative and differential detection of Influenza virus type A, including the present have-known subtypes and type B antigens directly from nasal swab specimens from individuals who have onset of symptoms, such as a sudden onset of fever, cough (usually dry), headache, muscle and joint pain and so on. The test is intended to be used as a screening test and provides an aid in the diagnosis of acute influenza type A and B viral infections. A negative test is presumptive and Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions. Alternative test method(s) should be considered to confirm the test result obtained by this device. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. For in vitro diagnostic use only. For self-testing.

SUMMARY
Influenza is an acute respiratory disease caused by influenza viruses (type A, type B and type C), which is highly infectious and has a short window period, and now it is mainly type A(H3N2) followed by type A(H1N1). Based on the current epidemiological investigation, the incubation period is generally 1 to 7 days, most of which are 2 to 4 days. Influenza patients usually have symptoms of high fever, headache, muscle pain and fatigue, accompanied by respiratory symptoms, such as sore throat, cough and sputum. The disease is self-limiting, but infants, the elderly, and patients with underlying cardiopulmonary diseases are prone to severe complications such as pneumonia and lead to death.

Materials Provided
• Test Cassettes • Extraction Buffer Tubes
• Disposable Swabs* • Package Insert
• Biohazard waste bag
* The Disposable Swabs are produced by another manufacturer. Nasal swabs in this kit.