RAPID HCV ANTIBODY TEST

For the qualitative assessment of HCV antibody in human serum, plasma and whole blood.

INTENDED USE:

Rapid HCV Ab Test is a chromatographic immunoassay for qualitative detection of the antibodies against hepatitis C virus (HCV Ab) in human serum, plasma and whole blood samples. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis C as well for primary screening of blood from volunteer donors on the spot.

SPECIFICATION:

1)        Specimen: whole blood/serum/plasma

2)        Format: strip/cassette

3)        Sensitivity: 99.79%

4)        Specificity: 99.55%

FEATURE:

1)        Simple: simply add specimen and dilution(if necessary) into sample well

2)        Rapid: results come out at 30 minutes

3)        Visually interpreted: don’t need any equipment

4)        Stable: more than 12 month period of validity

PACKING

1)        Strip: 100 tests/box,

2)        Cassette: 25 tests/box, 50 tests/box

ASSAY PROCEDURE:

1)        Allow the test card and sample to reach room temperature if necessary.

2)        Open the pouch, Take out the test card.

3)        Dispense 5 ul serum or plasma to the “S1” area indicated by the arrow mark.

4)        Add 2 drops (100ul) sample diluent into the sample well marked as “S”

5)        Read the results at 30 minutes.

Some Positive samples may show positive results before 30 minutes.

Results after 30 minutes may not be accurate.

PRINCIPLE:

Rapid HCV Ab test employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated goat anti-human IgM and mouse anti-human IgG are dried and immobilized on the fiberglass strip. HCV antigens are immobilized at the Test Zone (T) and goat anti mouse IgG antibodies are immobilized at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HCV antibodies will bind the gold conjugated anti-human IgG and/or IgM forming complexes. These complexes will continue to migrate along the strip until the Test Zone (T) zone where they are captured by the HCV antigens to form a visible red line. The un-bound gold conjugate will continue to move and bind with goat anti-mouse IgG at the Control Zone (C) forming a visible red line. If no HCV antibodies in sample, a red line is only appeared at the Control Zone (C), which indicates the validity of the test.