Syphilis Rapid Test

Product information

Syphilis Rapid Tests is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or whole blood.

Advantages of Syphilis test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Syphilis is a venereal disease caused by the spirochete organism Treponema pallidum (TP). As this organism cannot be cultured on artificial media, the diagnosis of syphilis depends on the correlation of clinical data with the specific antibody demonstrated by serological tests. Serological screening tests for syphilis utilizing cardiolipin and lecithin as antigens are simple to perform but biological false positive (BFP) reactions occur frequently because the tests use non treponemal antigens.

The TPI and FTA-ABS tests utilize pathogenic TP as the antigen but these tests present some difficulties for routine serodiagnosis. The TPI test requires living pathogenic and the FTAABS test requires a fluorescence microscope. Both tests require a high level of expertise. ELISA tests are easier to use but still requires specific equipment and trained personal.

Syphilis Rapid Test is a rapid qualitative screening test for detection of human antibodies to TP in serum, plasma or whole blood. The method employs an unique combination of anti-human immunoglobulins dye conjugate and highly purified TP recombinant protein to specifically detect anti TP antibodies.

The test mainly detects IgG and IgA, but IgM also reacting in case of high concentrations. As the samples flows through the absorbent device, the anti-human immunoglobulins dye conjugate binds to the human IgG antibodies forming an antibody-antigen complex.

This complex binds to the recombinant protein in the positive reaction zone and produces a pink-rose colored band. In the absence of anti TP antibodies, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device past the reaction and control zones. Unbound conjugate binds to the reagents in the control zone producing a pink-rose color band, demonstrating that the reagents are functioning correctly.

Test procedure

1. Allow samples and SYPH-CHECK-1 test devices to come to room temperature prior to testing.
2. Remove the reaction device from its protective wrapper by tearing along the split.
3. Label device with the patient’s name or control number.
4. Fill the serum dropper with specimen (serum or plasma) and by holding it vertically, dispense one drop (25 μL) into sample well (▷). If the whole blood is used, dispense two drops (50 μL) into the sample well (▷) and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Hold the diluent dropper bottle vertically and slowly add exactly 4 drops (150 μL) in the sample well (▷) with an interval of 2-3 seconds between each drop.
6. Read the results after 10 to 15 minutes. DO NOT INTERPRETE THE TEST AFTER 15 MINUTES

Interpretation of the results

Negative result: Only one colored band appears in the control zone. No band is visible in the test window.

Positive result: In addition to the control band, a clearly distinguishable band also shows in the test zone (T) indicating a positive result.

Invalid result: If there is no distinct colored band visible in the control zone (C), the test is inconclusive. In this case, it is recommended to repeat the test.