For the qualitative detection of Hepatitis B surface antigen in
serum or plasma.
The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for
direct qualitative detection of Hepatitis B type virus surface
antigen (HBsAg) in human serum or plasma.
The HBsAg RST is a chromatographic immunoassay (CIA) for the
detection of surface antigens of Hepatitis B in human serum or
plasma. Specific antibody against HBsAg is pre-coated onto membrane
as a capture reagent on the test region. During the test, specimen
is allowed to react with the colloidal gold particles, which have
been labeled with other specific antibodies. If HBsAg present, a
pink colored band will develop on the membrane in proportion to the
amount of HBsAg presented in the specimen. Absence of this pink
colored band in the test region suggests a negative result. To
serve as a procedural control, a pink colored band in the control
region will always appear regardless the presence of HBsAg.
REAGENTS AND MATERIALS PROVIDED
1. One pouched cassette with desiccant.
2. One piece of operating instruction.
WARNING AND PRECAUTIONS
1. FOR IN VITRO DIAGNOSTIC USES ONLY
2. All patient samples should be treated as if capable of
3. Do not interchange reagents from different lots or use test kit
beyond expiration date.
4. Icteric, lipemic, hemolysed, heat treated and ontaminated sera
may cause erroneous results.
The kits should be stored at temperature 4-30°C, the sealed pouch
for the duration of the shelf life (24 months).
INTERPRETATION OF RESULTS
Negative: No band in the test region (T), only one pink band appears in the
control region (C). This indicates that no HBsAg have been
Positive: In addition to the band in the control region (C), another pink
band will appear in the test region (T). This indicates that the
specimen contains HBsAg.
Invalid: If no band appears in the control region(C), regardless of the
presence or absence of line in the test region (T). It indicates a
possible error in performing the test. The test should be repeated
using a new device.
LIMITATION OF THE PROCEDURE
1. The test is to be used for the qualitative detection of HBsAg.
2. A negative result does not rule out infection by Hepatitis B
because the HBsAg may not be present in sufficient quality.
Contact Rebecca Yan