HBsAb Rapid Test Cassette (Serum/Plasma)

Applications:

The HBsAb Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of Antibody to Hepatitis B Surface Antigen in or plasma.

Description:

Viral hepatitis is a systemic disease primarily involving the liver. Most cases of acute viral hepatitis are caused by Hepatitis A virus, Hepatitis B virus (HBV) or Hepatitis C virus. The complex antigen found on the surface of HBV is called HBsAg. The presence of HBsAg in serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. The antibody to HBsAg, HBsAb, may not become detectable for 3-6 months after acute infection. It is associated with resolution of the illness. This antibody is recognized as the marker of immunity to HBV. As a result, vaccination against HBV was introduced to control the morbidity and mortality associated with the virus. As part of the World Health Organization (W.H.O) program for the control of Hepatitis B, many people, especially new born infants, receive vaccination. The minimum standard titer of HBsAb is 10 mIU/mL for protective immunity to HBV. Unfortunately, approximately 5-15% of healthy immunocompetent individuals either does not exhibit an antibody response to the existing recombinant vaccination or respond poorly. The HBsAb Rapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of HBsAb in serum or plasma specimen. The test utilizes a double antigen sandwich system to detect as low as 10mIU/ml of HBsAb in serum or plasma.

【DIRECTIONS FOR 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 to be 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)

POSITIVE:* 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 intensity of the color in the test line region (T) will vary depending on the concentration of HBsAb present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.

NEGATIVE: 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.