HCV Test INTENDED USE
The HCV Gold Rapid Screen Test is a Chromatographic immunoassay (CIA) for
direct qualitative detection of antibodies to Hepatitis C type
virus (HCV) in human serum or plasma.
HCV Test PRINCIPLE
The HCV RST is a chromatographic immunoassay (CIA) for the detection of
antibodies to HCV in human serum or plasma. HCV recombinant antigens are precoated
onto membrane as a capture reagent on the test region. During the
test, specimen is allowed to react with the colloidal gold
particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in
proportion to the amount of HCV antibodies present in the specimen. Absence of this pink colored
band in the test region suggests a negative result. To serve as a
procedural control, a purple colored band in the control region
will always appear regardless the presence of antibodies to HCV.
REAGENTS AND MATERIALS PROVIDED
1. One pouched cassette with desiccant.
2. One piece of operating instruction.
WARNING AND PRECAUTIONS
1.For in vitro diagnostic uses only.
2.All patient samples should be treated as if capable of transmitting
3.Do not interchange reagents from different lots or use test kit
beyond expiration date.
4.Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results.
HCV Test STORAGE
Store the test kit at temperature 4-30°C,the sealed pouch for the
duration of the shelf life (24 months).
SPECIMEN COLLECTION AND PREPARATION
1.Have a certified phlebotomist collect whole blood into a purple,
blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by veinpuncture.
2.Separate the plasma by centrifugation.
3.Carefully withdraw the plasma for testing, or label and store it
at 2-8°C for up to two weeks. Plasma may be frozen at -20°C for up
to one year.
1.Have a certified phlebotomist collect whole blood into a red top
collection tube (containing no anticoagulants) by veinpuncture.
2.Allow the blood to clot.
3.Separate the serum by centrifugation.
4.Carefully withdraw the serum for testing or label and store it at
2-8°C for up to two weeks. Serum may be frozen at -20°C for up to
HCV Test ASSAY PROCEDURE
Add 70-100 ul or 2-3 drops serum or plasma into sample well.
Observe the result in 5-30 minutes.
INTERPRETATION OF RESULTS
1.Negative: No apparent band in the test region(T), a pink-colored band
appears in the control region(C). This indicates that no HCV
antibody has been detected.
2.Positive: In addition to a pink-colored band in the control region(C), a
pink-colored band will appear in the test region (T). This
indicates that the specimen contains HCV antibodies.
3.Invalid: If no band appears in the control region(C), regardless of the
presence or absence of line in the test region (T). It indicates a
possible error in performing the test. The test should be repeated
using a new device.
LIMITATION OF THE PROCEDURE
1.The test is to be used for the qualitative detection of
antibodies to HCV.
2.A negative result does not rule out infection by HCV because the antibodies to HCV may be absent or may not be present in sufficient quantity to be
detected at early stage of infection.