FDA Home Use 40 kits One Step HCV Rapid Test Cassette

Product Specification

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.