Intended Use The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens. Principle The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. Storage and Stability 1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch. 2.The test must remain in the sealed pouch until use.
