INTRODUCTION

Legionella  Antigen Rapid Test Kit is an in vitro qualitative immunochromatographic assay for the rapid detection of legionella  antigens in human urine specimen. The test results are intended to aid in the diagnosis of legionella infection and to monitor the effectiveness of therapeutic treatment.

INTENDED USE

The test kit is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of urine sample is added to the sample well of the test cassette. The sample flows through a label pad containing legionella  serogroup I antibody coupled to red-colored colloidal gold. If the sample contains legionella serogroup I antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes.

These complexes move on the nitrocellulose membrane by capillary action toward the test line region on which Legionella  specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If legionella antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.