【SUMMARY】
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 (Whole
Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of
antibody to HCV in a whole blood, serum or plasma specimen. The test utilizes
colloid gold conjugate and recombinant HCV proteins to selectively detect
antibody to HCV in whole blood, 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.
【DIRECTIONS FOR USE】
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. For Serum or Plasma specimen: Hold the dropper vertically and transfer 2
drop of serum or plasma (approximately 50 μl ) to the specimen area, then add 1
drops of buffer (approximately 40 μl ),and start the timer, see illustration
below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer
2 drops of whole blood (approximately 50 μl ) to the specimen area, then add 1
drop of buffer (approximately 40 μl ), and start the timer. See illustration
below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately
50 μl of fingerstick whole blood specimen to the specimen area of
test dipstick, then add 1 drops of buffer (approximately 40 μl ) and start the
timer. See illustration below.
· To use hanging drops: Allow 2 hanging drops of fingerstick whole blood
specimen (approximately 50 μl ) to fall into the specimen area of test
dipstick, then add1 drop of buffer (approximately 40 μl ) and start the timer.
See illustration below.
3. Wait for the colored line(s) to appear. The test result should be read at 10
minutes.
4. Do not interpret the result after 20 minutes.