Intended Use

The Hepatitis C Virus (HCV) Rapid Test Kit is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus (HCV) in Whole Blood /Serum / Plasma to aid in the diagnosis of Hepatitis C Virus infection

Summary

Hepatitis C Virus now is recognized as a major of chronic hepatitis, transfusion=acquired non-A, non-B hepatitis and liver disease throughout the world. HCV is an enveloped positive-sense, single-stranded RNA virus. Clinical diagnostic issues related to HCV is the detection of HCV antibodies in Whole Blood /Serum / Plasma. Hepatitis C Virus (HCV) Rapid Test Kit is a simple, visual qualitative test that detects antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Principle

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