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One step HBsAg test
strip
INTRODUCTION
One
Step Strip Style HBsAg Test is a rapid direct binding test
for the visual detection of hepatitis B surface antigen (HBsAg)
in serum as an aid in the
diagnosis of hepatitis B infection. One Step HBsAg Test is
based on the principle of sandwich immunoassay for
determination of HBsAg in
serum. Monoclonal and polyclonal antibodies were employed to
specifically identify HBsAg with high sensitivity. This one
step test only takes
about 10-20 minutes. Test results are read visually without
any instrument.
SPECIMEN COLLECTION
For serum, collect blood into a
container without anticoagulant. Allow the blood to clot and
separate the serum from the clot. Use the serum for
testing. If the specimen cannot be tested on the day of
collection, store the serum specimen in a refrigerator or
freezer. Bring the specimens to
normal room temperature before testing. Do not freeze and
thaw the specimen repeatedly.
TEST PROCEDURE
1.When you are ready to
begin testing, open the sealed pouch by tearing along the
notch. Remove the test from the pouch.
2.Dip the test strip with
arrow downside into the serum for about 5 seconds. Do not
exceed the marker line.
3.Wait 10-20 minutes and
read results. Do not read results after 30 minutes.
INTERPRETATION OF RESULTS
*Negative:Only
one colored band appears on the control region. No apparent
band on the test region.
*Positive:In
addition to a pink colored band, a distinct pink colored
band will also appear in the test region.
*Invalid:A
total absence of color in both regions is an indication of
procedure error and/or that test reagent deterioration has
occurred.
STORAGE AND STABILITY
The test strip can be
stored at room temperature(18 to 30℃)in the sealed pouch for
duration of shelf life. The test strip
should be kept away from
direct sunlight, moisture and heat.
PRECAUTION
*For in vitro diagnostic
use only.
*Do not use test strip
beyond expiry date.
*The test strip should not
be reused.
