QUALITY
ASSURANCE
WHAT IS THE PRINCIPLE BEHIND THE ONE STEP HBSAB AND HOW DOES IT
DETECT HEPATITIS B ANTIBODIES?
The Advanced Quality One Step HBsAb Test is a rapid, one step immunochromatographic assay
for the detection of antibodies to Hepatitis B surface antigen (HBsAb) in human serum. It uses the
“sandwich principle”, a solid phase colloidal gold enhanced immunoassay technique for determination of HBsAb in human serum or plasma. The nitrocellulose membrane was immobilized with
HBsAg on the test band region and anti-HBsAg antibody on the control band region. During the
test, the specimen is allowed to react with the colored conjugate (HBsAg colloid gold conjugate);
the mixture then migrates chromatographically on the membrane by the capillary action. The
result is then read and interpreted.
WHAT ARE THE SPECIMENS REQUIRED TO RUN THE ONE STEP HBSAB TEST?
Serum or plasma maybe used in the test.
DO ANTICOAGULANTS INTERFERE WITH THE TEST?
Anticoagulants typically used for blood collection do not interfere with this test.
WHAT MAY HAPPEN IF HEMOLYZED, LIPEMIC OR ICTERIC SPECIMENS ARE
USED?
Hemolyzed, lipemic or icteric specimens are NOT suitable for this assay. Specimens containing
particulate matter may give inconsistent results and should be clarified prior to testing.
HOW LONG WILL THE RESULT BE OBTAINED USING THE ONE STEP HBSAB
TEST?
Results using this test can be interpreted at 15 minutes.
WHAT MAY CAUSE FALSE POSITIVE RESULTS ON THE ONE STEP HBSAB TEST?
False positive reactions may result from cross-reactions in the immune “sandwich” complex.
False positive reactions may include reactions with certain glycoproteins, such as concanavalin A,
which interact with HBsAg.
WHAT DOES EACH KIT CONTAIN?
Each kit contains Test cards/strips, individually foil pouched with a desiccant, package insert and
a sample dispensing plastic dropper with each test pouch.
WHAT IS THE DIFFERENCE WITH REGARDS TO DETECTION BETWEEN ANTIBODY AGAINST HEPATITIS B SURFACE ANTIGEN AND HEPATITIS B SURFACE
ANTIGEN? WHAT ARE THEIR PURPOSES?
Hepatitis B surface antigen indicates active infection; it is detected from 4 to 22 weeks. This is the
first antigen to appear during acute infection and its disappearance indicates recovery from
infection. Antibody against Hepatitis B surface antigen is detected for years in both acute and
chronic infections. It is an indication that the patient has recovered from Hepatitis B and has a
protective immunity from the disease. It is important to know the structure of the Hepatitis virus
and its indication for proper diagnosis of the patient.
WHAT’S THE DIFFERENCE BETWEEN THE ONE STEP HBSAB TEST CARD AND
TEST STRIP?
For ease of use, the test card has this advantage because of the prevention of spillage of specimen. This may also prevent the risk of spreading the infection. With regards to cost, the test strip
is much cheaper than the test card. It is up to the end-user which would be more convenient for
them to use.