Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibody to HCV is found in over 80% of patients with well- documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to the first generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests.
The HCV Rapid Test Dipstick (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a serum or plasma specimen. The test utilizes colloid gold conjugate and recombinant HCV proteins to selectively detect antibody to HCV in serum or plasma. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.
ˇľDIRECTIONS FOR USEˇż
Allow test Dipstick, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test Dipstick from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test card on a clean and level desk, then peel off the strip label of the test card, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 µL) to the specimen well, then add 2 drops of buffer (approximately 120 µL),and start the timer, see illustration below. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
|
Cat. No. |
Product Description |
Specimen |
Format |
Kit Size |
Cut-Off |
Status |
|
IHC-301 |
HCV Rapid Test Dipstick |
S / P |
Dipstick |
50 T |
See Insert |
Non-CE |
