Infection Disease Hepatitis C HCV Rapid Test Device

For professional in vitro diagnostic use only

INTENDED USE

The HCV Rapid Test Strip (Whole Blood /Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection.

INTRODUCTION

Hepatitis C Virus (HCV) is a small, enveloped, positive‐sense, single‐stranded RNA Virus.

HCV is now known to be the major cause of parenterally transmitted non‐A, non‐B hepatitis. Antibody to HCV is found in over 80% of patients with well‐documented non‐A, non‐B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross‐reactivity and to increase the sensitivity of the HCV antibody tests.

PRINCIPLE

The HCV Rapid Test Strip (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.