Rapid Diagnostic Blood Detection Kit High Accuracy For Hepatitis B Core Antibody

One Step HBcAb Rapid Diagnostic Test for detecting Hepatitis B Core Antibody, gold colloidal method, high accuracy

Product Name: One Step HBcAb Rapid Diagnostic Test Cassette

Intended Use:

The HBcAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Hepatitis B Core Antibody (HBcAb) in serum or plasma.

Summary:

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus (HAV), Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Hepatitis B core antibody is a viral protein secreted by HBV infected cells. Its presence indicates high levels of virus in the blood, and it is an indicator of the infectiousness of the carrier. If this test is negative, but a person is known to be HBcAb positive, then it indicates low levels of virus in the blood or an "integrated phase" of HBV in which the virus is integrated into the host’s DNA. The HBcAb Rapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBcAb in serum or plasma specimen. The test utilizes a combination of monoclonal antibodie and antigen to selectively detect elevated levels of HBcAb in serum or plasma. This one step test is very sensitive and only takes about 10-20minutes. Test results are read visually without any instrument.

TEST 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 anti-HBcAg on the test line region of the strip. During testing, if HBcAb present in the specimen, will compete with particle coated HBcAg antibody for limited amount of anti-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 HBcAb 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.

TEST PROCEDURE

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:

Two red lines are visible in the result window. The intensity of the test line may be

weaker or darker than that of the control line. This still means a positive result.

Negative:

The control line appears in the result window, but the test line is not visible.

Invalid:

If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.