INTRODUCTION

This kit uses immunochromatography technology to qualitatively detect treponema pallidum antibody in human serum, plasma or whole blood. It is suitable for the early aid of treponema pallidum infection diagnosis and screening.

INTENDED USE

The Treponema Pallidum Antibody Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of TP antibody in Whole Blood /Serum / Plasma. In this test procedure, recombinant TP antigen is immobilized in the test line region of the test card. After a Whole Blood /Serum / Plasma sample is placed in the sample well, it reacts with TP antigen coated particles that have been applied to the sample pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized TP antigen. If the sample contains TP antibody, a colored line will appear in the test line region indicating a positive result. If the sample does not contain TP antibody, a colored line will not appear in this region indicating 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 sample has been added and membrane wicking has occurred.