INTRODUCTION

This kit is used for qualitative detection of human immunodeficiency virus 1/2 antibody, treponema pallidum antibody in human whole blood, serum or plasma in vitro.

INTENDED USE

The HIV/TP Antibody Combo Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of HIV or TP antibody in Whole Blood /Serum / Plasma samples. In this test procedure, recombinant HIV and TP antigen is immobilized in the test line region of the device. After a Whole Blood/Serum/Plasma sample is placed in the sample well, it reacts with HIV and 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 HIV and TP antigen. If the sample contains HIV or TP antibody, a red line will appear in the test line region indicating a positive result. If the sample does not contain HIV or TP antibody, a red line will not appear in this region indicating a negative result. To serve as a procedural control, a red line will always appear at the control line region indicating that proper volume of sample has been added and membrane wicking has occurred.