Syphilis Antibody Rapid Test

INTENDED USE

Syphilis Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma to aid in the diagnosis of Syphilis.

MATERIALS

Materials Provided

Materials Required but Not provided

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

1. 1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. 2. Place the test device on a clean and level surface.

3. For Serum or Plasma Specimens: 

   Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 5 mL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

   For Whole Blood (Venipuncture/Fingerstick) Specimens:

   To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 1 drop of whole blood (approximately 10 µL) to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer. See illustration below.

   To use a micropipette: Pipette and dispense 10 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 90 µL) and start the timer.

   1. 3. Wait for the colored line(s) to appear. Read results at 10 minutes.Do not interpret the result after 20 minutes.

   2. INTERPRETATION OF RESULTS
      
      

      POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

      NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).

      INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

      NOTE:

      1. The intensity of color in the test region (T) may vary depending on the concentration of TP antibodiesin the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of TP antibodies in the specimen.
      2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

      3. LIMITATIONS OF THE TEST

         1. 1. The Syphilis Test is for in vitro diagnostic use only. The test should be used for the detection of TP antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in TP antibody concentration can be determined by this qualitative test.
         2. 2. The Syphilis Antibody Rapid Test will only indicate the presence of TP antibodies in the specimen and should not be used as the sole criteria for the diagnosis of TP infection.
         3. 3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.
         4. 4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of TP.
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