FDA Home Use 40 kits One Step HCV Rapid Test Cassette
Brand Name:Newscen
Certification:ISO9001, CE, TUV, FDA
Model Number:HCV (Hepatitis C Virus)
Minimum Order Quantity:10 Boxes or 400 Kits (40 Kits/Box)
Delivery Time:8 days
Payment Terms:T/T, Western Union, MoneyGram
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Location:
Tianjin Tianjin China
Address:
No. 65 Sixth Ave .,TEDA Tianjin , 300457 P. R. China
Supplier`s last login times:
within 22 hours
Product Details
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Product Details
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
► Instruction for use
► Each pouch contains one cassette with one desiccant bag
Materials Required But Not Provided
►Timer or stopwatch
► Biohazard disposal container
► Disposable gloves
► Blood collection devices, for the testing of venipuncture whole
blood, serum or plasma
For finger stick samples, the following materials are required:
► Sterile lancet
► Alcohol pad
► Sterile gauze or cotton
Sample Collection and Test Preparation
Finger stick Specimens(Whole Blood)
► Clean the area to be lanced with an alcohol pad.
► Squeeze the end of the fingertip and pierce it with a sterile
lancet.
► Wipe away the first drop of blood with sterile gauze or
cotton；collect the sample from the second drop.
► Use dropper to draw the fresh blood to 1/ 2 of the tube wall and
dispense into the sample well.
Finger stick whole blood should be used immediately after
collection.
Serum/Plasma specimens:fresh serum or plasma specimen can be used.
No special patient preparation required.
Plasma
► Collect whole blood into a collection tube(containing EDTA,
Na-citrate or heparin) by venipuncture.
► Separate the plasma by centrifugation.
Serum
► Collect whole blood into a collection tube(containing no
anticoagulants) by venipuncture.
► Allow the blood to clot.
► Separate the serum by centrifugation.
Avoid the use of hemolytic, turbid, microorganism contaminated
specimens. Specimen should be stored at 2-8℃for 5 days or frozen
at-20℃for maximum 3 months. Avoid specimen deterioration by
multiple freeze-thaw cycles.
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.
FDA Home Use 40 kits One Step HCV Rapid Test Cassette
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