HBcb-P02B (HBcAb)One Step Hepatitis B core Antibody Test Cassette

PRINCIPLE

The HBcAb test is immunoassay based on the principle of competitive binding. During testing, the mixture migrates upward on the membrane chromatographically by capillary action. The membrane is pre-coated with HBcAg on the test line region of the strip. During testing, if anti-HBc antibody, present in the specimen, will compete with particle coated anti-HBc antibody for limited amount of HBcAg on the membrane. No line will form in the test region. And a visible colored line will form in the test region if there is no anti-HBc antibody in the specimen because all the antibody coated particles will be captured by the antigen coated in the test line region.

To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND STORAGE

• The HBcAb One Step Hepatitis B c Antibody Test Device (Serum/Plasma) can be performed using either serum or whole blood.

• Separate the serum or plasma from blood as soon as possible to avoid hemolysis. Only clear, non-hemolyzed specimens can be used.

• Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.

• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.

• If specimens are to be shipped, they should be packed in compliance with local regulations for the transportation of etiologic agents.

PROCEDURE

Allow test device,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 device 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. Put the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of serum or plasma (approx. 75 mL) to specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.

3. Wait for the colored line(s) to appear. The result should be read at 15 minutes. Do not interpret the results after 20 minutes.

INTERPRETATION OF RESULTS

POSITIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

NEGATIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.