It is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum or plasma. In this test procedure, recombinant Syphilis antigen is immobilized in the test line region of the test.

After specimen is added to the specimen well of the device, it reacts with Syphilis antigen coated particles in the test. This mixture migrates chromatographically along the length of the test and interacts with the immobilized Syphilis antigen. The double antigen test format can detect both IgG and IgM in specimens. If the specimen contains TP antibodies, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a colored line will not appear in this region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

• 1.Syphilis Rapid Test Device/Strip (Serum/Plasma)
• Allow the test, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.

• 1.Remove the test strip from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

• 2.Hold the dropper vertically and transfer 2 drops of serum or plasma (approximately 50 mL) onto the Specimen Pad of the test strip, then add 1 drop of buffer (approximately 40 mL) and

• start the timer.

• 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.

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• 2.Syphilis Rapid Test Device(Whole Blood/Serum/Plasma)
• Allow the test, specimen, buffer and/or controls to reach room temperature (15‐30°C)
• prior to testing.

• 1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

• 2.Place the device on a clean and level surface.

• For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25mL) to the specimen well (S), then add 2 drops of buffer  (approximately 80mL), and start the timer.
• For Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 80mL) to the specimen well (S), then add 1 drop of buffer (approximately 40 mL), and start the timer.
• 3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 30 minutes.

Allow the test, specimen, buffer and/or controls to reach room temperature (15‐30°C) prior to testing.

For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 mL) onto the Specimen Pad of the test strip, then add 2  drops of buffer (approximately 80 mL) and start the timer.

For Fingerstick Whole Bloodspecimens:

Fill the capillary tube and transfer approximately 50 mL (or 2 drops) of fingerstick whole blood specimen onto the Specimen Pad of the test strip, then add 2 drops of buffer (approximately 80 mL) and start the timer.