INTRODUCTION

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

INTENDED USE

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