INTRODUCTION

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

INTENDED USE

The HAV/HBsAg/HCV/HIV/TP Combo Rapid Test Kit is a qualitative membrane strip based immunoassay for the detection of HAV or HBsAg or HCV or HIV or TP antibody in Whole Blood /Serum / Plasma samples . In this test procedure, recombinant HAV, HBsAg, HCV, 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 HAV, HBsAg, HCV, 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 HAV, HBsAg, HCV, HIV and TP antigen. If the sample contains HAV or HBsAg or HCV or HIV or TP antibody, a colored line will appear in the test line region indicating a positive result. If the sample does not contain HAV or HBsAg or HCV or HIV or 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.