ISO13485 / CE HBcAb Rapid Test Kits to detect Hepatitis B Core Antibody (HBcAb) in serum or plasma

Appliation:

Description:

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 antibodies and antigen to selectively detect elevated levels of HBcAb in serum or plasma. This one step test is very sensitive and only takes about 15-20 minutes. Test results are read visually without any instrument.

How to use?

Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30 ℃) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μl) to the specimen well of test device and start the timer. Avoid trapping air bubbles in the specimen well. See illustration below.
3. Wait for the colored line is appeared. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T).
*NOTE: The shade of red in the test line region (T) may vary, but it should be considered negative whenever there is even a faint pink line.
POSITIVE: One colored line appears in the control region (C). No apparent colored line appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.