HBV-5 PANEL TEST

For the qualitative assessment of the markers of hepatitis B virus infection in human serum, plasma and whole blood.

INTENDED USE:

This HBV Panel Test is an immunochromatographic assay to quickly detect five major markers of HBV infections, HBsAg, Anti-HBs (HBsAb), Anti-HBc (HBcAb), HBeAg and Anti-HBe (HBeAb) in human blood specimens. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products.

SPECIFICATION:

1)        Specimen: whole blood/serum/plasma

2)        Format: strip/cassette/panel

3)        Accuracy: HBsAg-99.6%

               HBsAb-97.9%

               HBcAb-97.4%

               HBeAg-99.6%

               HBeAb-98.2%

FEATURE:

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

2)        Rapid: results come out early than 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, 500 tests/box

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

3)        Panel: 25 tests/box, 50 tests/box

ASSAY PROCEDURE:

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

2)        Use provided plastic pipet to add 2 to 3 drops (80-120 uL) of serum or plasma to each corresponding sample well respectively.

3)        Results at 30 minutes. For HBsAg, HBsAb and HBeAg, the strong positive sample may show results earlier than 30 minutes. For HBeAb and HBcAb, negative results may show results earlier than 30 minutes.

PRINCIPLE:

HBsAg test is an antibody sandwich immunoassay. Colloidal gold conjugated monoclonal antibodies reactive to HBsAg (sAb-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion trough the strip rehydrating the gold conjugate. If present, HBsAg will bind with the gold conjugated antibodies forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-HBs antibodies immobilized there and a visible red line appears. If there is no HBsAg in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-mouse IgG antibody and aggregating in a red line, which indicates the validity of the test.

HBsAb test is an antigen sandwich immunoassay. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold HBsAg conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with HBsAg that is coated on the test region. If anti-HBsAg antibody is present, the result is the formation of a colored band in the test region.  If there is no HBsAg antibody in the sample, the area will remain colorless. The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid.

HBeAg test is an antibody sandwich immunoassay. When specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold anti-HBeAg conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-HBeAg antibody that is coated on the test region. If HBeAg is present at levels of 1 ng/ml or greater, the result is the formation of a colored band in the test region.  If there is no HBeAg in the sample, the area will remain colorless. The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid.

HBeAb test is a competitive immunoassay. The nitrocellulose membrane was immobilized with anti-HbeAg antibody on the test region. During the assay, the presence of anti-HBeAg antibody (HBeAb) in the specimen will compete with gold-anti HBeAg antibody conjugate for the limited amount of HBeAg that is pre-coated on the sample pad. The mixture moves along the membrane by capillary action and reacts with Anti-HBeAg antibody that is coated on the test region. If anti-HBeAg antibody is present, the test region will remain colorless. If there is no anti-HBeAg antibody in the sample, the test region will form a color band. The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid.

HBcAb test is a competitive immunoassay for the detection of anti-Hepatitis B Virus core antigen (HBcAg) in human blood specimen. When the specimen is added to sample pad, it moves through the conjugate pad and mobilizes gold-HBcAg conjugate that is coated on the conjugate pad. The mixture moves along the membrane by capillary action and reacts with anti-HBcAg that is coated on the test region. If anti-HBcAg antibody is absent, the result is the formation of a colored band in the test region. If there is HBcAg antibody in the sample, it will compete with anti-HBcAg coated on the membrane to bind Au-HBcAg conjugate. When the anti-HBcAg antibody level is higher than the cut-off, it will prevent Au-HBcAg to bind to anti-HBcAg coated on the test region. The test band will remain colorless. The sample continues to move to the control area and forms a pink to purple color, indicating the test is working and the result is valid.