INTRODUCTION

The Yellow Fever Antigen Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of antigen of Yellow Fever in human whole blood, serum or plasma specimens to assist in the diagnosis of Yellow Fever infections.

INTENDED USE

he Yellow Fever Antigen Rapid Test Kit is a qualitative membrane-based immunoassay for the detection of Yellow Fever antigen in whole blood, serum, or plasma. During the test procedure, capture reagent is immobilized in the test line region (T) of the test. After specimen is added to the specimen well (S) of the device, the specimen reacts with Yellow Fever antibody-conjugate in the test cassette. The Gold antibody conjugate will bind to Yellow Fever antigen in the specimen sample which in turn will bind with Anti-Yellow Fever coated on the membrane. As the reagent moves across the membrane, the Yellow Fever antibody on the membrane will bind the antibody-antigen complex causing a dark red or pink line to form at the test line region of the test membrane. The intensity of the lines will vary depending upon the amount of antigen present in the sample. If the specimen contains Yellow Fever antigen, a colored line will appear in the test line region (T), indicating a positive result. If the specimen does not contain Yellow Fever antigen, a colored line will not appear in this region, indicating a negative result.

An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line,regardless of whether there is a test line or not.