【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.
