HBsAg Rapid Test Cassette

【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 Cassette 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 cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
· Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 μl) to the specimen well of test Cassette 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 cassette, then add 1 drop of buffer (approximately 40 m mL) 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 30 days after opening the vial.