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One Step Anti- Syphilis test Card

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.Draw 0.2ml (about 5 drops) sample into the pipette, and dispense it into the sample well on the cassette.

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(C). No apparent band on the test region(T).

*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 kit can be stored at room temperature(18 to 30℃)in the sealed pouch for duration of shelf life. The test kit should be kept away from direct sunlight, moisture and heat.

PRECAUTION

* For in vitro diagnostic use only.

*Do not use test kit beyond expiry date.

*The test kit should not be reused.

NOTE: A difference in intensity may occur between the lines in the test region (T) and control region (C) but this does not affect the interpretation of the results.