INTRODUCTION

This kit is used for qualitative detection of hepatitis B virus surface antigen, hepatitis C virus antibody in human whole blood, serum or plasma in vitro.

INTENDED USE

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