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.
WARNING
For invitro diagnostic use ONLY
Storage
Newscen HCV Antibody Rapid Test should be stored at 4-30°C(do not
freeze) for 24 months from the date of manufacture. Keep the test
cassette in sealed pouch until use. Once you have taken the test
cassette out of the pouch, perform the test as early as
possible(within 1hour) to avoid test cassette from becoming moist.
Do not use the test beyond the indicated expiration date.
The diluent buffer should be stored at 4-30°C(do not freeze) for 24
months from the date of manufacture. After the diluent is opened,
it will be stored for 24 months according to the validity period.
