Professional Manufacturer of Rapid Test Devices
|Place of Origin:||China|
|Certification:||ISO9001, CE, TUV, FDA|
|Model Number:||HCV (Hepatitis C Virus)|
|Minimum Order Quantity:||10 Boxes or 400 Kits (40 Kits/Box)|
|Price:||Negotiable as per Order Quantity|
|Packaging Details:||40 Kits/Box, 50 Boxes/Carton, 317g/Box, 18kgs/Carton, Box Size: 250x125x65mm, Carton Size: 650x510x330mm|
|Delivery Time:||8 days|
|Payment Terms:||T/T, Western Union, MoneyGram|
|Supply Ability:||100,000 Kits Per Day|
|Specimen:||Serum, Plasma, Whole Blood||Methodology:||Colloidal Gold|
|Shelf Life:||2 Years||Format:||Cassette|
|OEM / ODM:||Available||Result Time:||Read In 20 Minutes|
HCV Rapid Test Cassette,
40 Kits HCV Rapid Test Cassette,
FDA HCV Rapid Test Cassette
HCV(Hepatitis C Virus) Antibody Rapid Test Kit
For the qualitative detection of HCV antibodies in serum/plasma and whole blood
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.
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.
► Collect whole blood into a collection tube(containing EDTA, Na-citrate or heparin) by venipuncture.
► Separate the plasma by centrifugation.
► 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.
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.
For invitro diagnostic use ONLY
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.
Contact Person: Mr. Randy.Zhang