NewScen Coast Bio-Pharmaceutical Co., Ltd

INTENDED USE
Rapid Diagnostic Test for Hepatitis C Virus Antibody (Colloidal Gold) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.

PRINCIPLE
Rapid Diagnostic Test for Hepatitis C Virus Antibody (Colloidal Gold) is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. 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 are 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 pink colored band in the control region will always appear regardless the presence of antibodies to HCV.

STORAGE
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

ASSAY PROCEDURE
Serum/Plasma
Add 2 drops (70 µl) of sample (serum/plasma) into the sample well. Observe the result in 20 minutes.
Whole blood

Add 1 drop (1 drop = 35µl) of sample (whole blood) into the sample well. After all samples completely absorbed, add 1 drop of diluent. Observe the result in 5-15 minutes.

INTERPRETATION OF RESULTS
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.
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.
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.