INTRODUCTION

The HBsAg/HCV/HIV/Syphilis Combo Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of HBsAg and HCV/HIV/Syphilis antibody in Whole Blood /Serum / Plasma to aid in the diagnosis of HBsAg/HCV/HIV/Syphilis infection.

INTENDED USE

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