LifeSign Status Flu A/B Tests

Status Flu A&B utilizes the chemical extraction of viral antigens followed by solid-phase immunoassay technology for the detection of extracted antigen, influenza A and/or B. In the test procedure, a specimen is collected and placed for one minute into the Extraction Well of the test device containing extraction solution, during which time antigen is extracted from disrupted virus particles. The test device is then raised, tapped and laid back down onto a level surface to allow the solution in the Extraction Well to migrate through the pads containing detector antibodies conjugated to gold dye and then through the test membrane.

If influenza antigens are present in the specimen, they will react with anti-infl uenza antibody coupled to gold dye particles, migrate through the membrane as antigen-antibody-dye complexes, bind to the immobilized anti-infl uenza antibody on the membrane, and generate a colored line in the Test line position (A and/or B). The rest of the sample and unbound/bound dye complexes continue to migrate to the Control line position (C), where antibody to the anti-infl uenza antibody is immobilized, and forms the Control line. Formation of the Control line serves as an internal control to demonstrate that antibodies in the dye pad have been hydrated and that suffi cient sample has been applied to allow for migration to the Test line and beyond. If the Control line does not appear within the designated incubation time, the result is invalid and the test should be repeated.

Status Flu A&B has two Test lines, one for infl uenza A and one for infl uenza B. The two Test lines allow for the separate and differential identifi cation of influenza A and/or B from the same specimen. If either Test line appears in the test result window, together with the Control line, the test result is positive for influenza.