INTRODUCTION
One Step Anti-Syphilis Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies
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 are employed to identify
anti-Syphilis antibodies specifically. This one step test is very sensitive and only takes about 10 to 20
minutes.
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 room temperature before testing. Do not freeze and thaw the specimen
repeatedly.
TEST PROCEDURE
Strip
1.When you are ready to begin testing, open the sealed pouch by tearing
along the notch. Remove the test from the pouch.
2. Immerse the strip into the container with the arrow end pointing
towards the container. Do not immerse past the MAX (maximum) line.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry,
nonabsorbent surface (e.g., mouth of the serum container).
3.Wait 10-15 minutes and read result. Do not read results after 20
minutes.
Cassette
1. Open a pouch containing a cassette, lay the cassette.
2. Using the plastic pipettor provided, draw about 2-3 drops (100mL)
the sample into the sample well of the cassette.
3. Read results within 10-15 minutes. Do not read results after 20
minutes.
INTERPRETATION OF RESULTS
Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable Anti-Syphilis in
the serum.
Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of
Anti-Syphilis.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test
should be repeated using a new device.
PRECAUTION:
1、Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2、Use it before expiry date.
3、The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
4、Old Serum can not be used. If the serum is thick, it can be used only after being separated.
LIMITATIONS
1、The test is for in-vitro diagnostic use only.