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One Step Strip style Anti-
Syphilis test
INTRODUCTION
One Step Strip Style Anti-Syphilis Test
is a rapid direct binding test for the visual detection of
antibodies to syphilis in serum as an aid in the diagnosis
of syphilis infection. Test results are read visually
without any instrument. It is based on the principle of
double antigen sandwich immunoassay for determination of
syphilis antibodies in serum. Purified recombinant syphilis
antigens were employed to specifically identify syphilis
antibodies with high sensitivity. This one step test only
takes about 10-20 minutes.
SPECIMEN COLLECTION
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 Max line. Take the strip out and
lay it flat on a clean, dry, non-absorbent surface.
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.
