【SUMMARY】
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 10mIU/ml for protective immunity to HBV. Unfortunately, approximately 5-15% of healthy immune competent individuals either does not exhibit an antibody response to the existing recombinant vaccination or respondpoorly. The HBsAb Rapid Test Dipstick (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 dipsticks, serum or plasma specimen, and/or controls to equilibrate to room temperature (15-30 ℃) prior to testing.
1. Remove the test dipstick 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. With arrows towards pointing toward serum or plasma specimen, immerse the test Dipstick vertically in the serum or plasma for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test Dipstick when immersing the Dipstick. See illustration below.
3. Place the Dipstick on a non-absorbent flat surface, start the timer and wait for the color line (s) to appear. The result should be read at 15 minutes.
Note: A low HBsAb concentration might result in a weak line appearing in the test region (T) after an extended period of time; therefore, do not interpret the result after 20 minutes.

 

Cat. No.	Product Description	Specimen	Format	Kit Size	Cut-Off	Status
IHBSB-301	HBsAb Rapid Test Dipstick	S / P	Dipstick	50 T	See Insert	Non-CE