Infection Disease Hepatitis C HCV Rapid Test Device
| Product Name | Infection Disease Hepatitis C HCV Rapid Test Device |
| Formats | Strip(3mm)Device(4mm) |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
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.
