Fingertip Specimens HCV Hepatitis C Virus Fast Detection Cassette
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.
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