【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. Previous designations included the Australia or Au antigen. The presence of HBsAg in whole blood, serum or plasma is an indication of an active Hepatitis B infection, either acute or chronic. In a typical Hepatitis B infection, HBsAg will be detected 2 to 4 weeks before the ALT level becomes abnormal and 3 to 5 weeks before symptoms or jaundice develop. HBsAg has four principal subtypes: adw, ayw, adr and ayr. Because of antigenic heterogeneity of the determinant, there are 10 major serotypes of Hepatitis B virus.
The HBsAg Rapid Test Dipstick is a rapid test to qualitatively detect the presence of HBsAg in whole blood, serum or plasma specimen. The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of HBsAg in whole blood, serum or plasma.

【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test Dipstick from the sealed pouch and use it within one hour.
2. Place the test cards on a clean and level desk, then peel off the strip label of the test cards, stick the test dipstick onto it as soon as possible before testing.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μl) to the specimen area of test Dipstick and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 3 drops of whole blood (approximately 75 μl) to the specimen area, then add 1 drop of buffer (approximately 40 μl), and start the timer.
See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 75 μl of fingerstick whole blood specimen to the specimen area of test Dipstick, then add 1 drop of buffer (approximately 40 μl) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read results at 15~30 minutes. Do not interpret the result after 30 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.