HCV(Hepatitis C Virus) Antibody Rapid Test Kit

For the qualitative detection of HCV antibodies in serum/plasma and whole blood

Intended Use

Newscen HCV Antibody Rapid Test is for the detection of antibodies to Hepatitis C type virus(HCV) in human serum, plasma or whole blood collected from vein or fingertip. It is intended for use in medical institutions by trained staff.

Principle

HCV(Core and NS 3) specific recombinant antigens are precoated on to the membrane as the capture reagent on the test zone.

During the test, specimen is allowed to react with the colloidal gold particles,which have been conjugated with HCV specific recombinant antigens. Antibodies to HCV, if present, will specifically bind to colloidal gold-antigen complex.

When the colloidal gold-antigen-antibody complexes move to the test zone, they will specifically bind to the precoated antigens. At the same time, a red colored I in e will develop in the test zone. Absence of this red colored line in the test zone suggests a negative result. To serve as a procedural control, red colored line in the control zone will always appear regardless of the presence of antibodies to HCV.

Reagents and Materials Provided

Each Kit Contains:

☀ 40 test cassettes(individually pouched)

☀ One bottle of diluent buffer(5mL)

☀ 40 disposable plastic droppers

☀ Each pouch contains one cassette with one desiccant bag

☀ Instruction for use

Materials Required But Not Provided

☀ Timer or stopwatch

☀ Biohazard disposal container

☀ Blood collection devices, for the testing of venipuncture whole blood, serum or plasma

☀ Disposable gloves

For finger stick samples, the following materials are required

☀ Sterile lancet

☀ Alcohol pad

☀ Sterile gauze or cotton

Built-In Control

Newscen HCV Antibody Rapid Test has a built-in procedural control that demonstrates assay validity. A redline appeared on the control zone(C) indicates that the test runs correctly.