Syphilis Rapid Test CE Marking


Product Number: RAPG-SPH-001 (Test Cassette - Serum, Plasma)
Product Number: RAPG-SPH-002 (Test Cassette - Serum, Plasma, Whole Blood)
Product Number: RAPG-SPH-003 (Test Strip - Serum, Plasma)
Product Number: RAPG-SPH-004 (Test Strip - Serum, Plasma, Whole Blood)

Product Description

The Biopanda Syphilis Rapid test qualitatively detects for the presence of antibodies IgG and IgM to Treponema Pallidum (TP) in (whole blood), serum, or plasma samples to aid in the diagnosis of Syphilis.

Test attributes

  • (Whole Blood), Serum or plasma samples may be used for testing
  • Results available in only 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of Syphilis infections

Test procedure

  1. Ensure specimen and test kits are brought to room temperature before testing.
  2. Open the foil wrapped pouch and remove the cassette. Place the cassette on a flat, clean surface. Use test immediately after opening.
  3. Using a dropper provided transfer 1 drops of the serum or plasma or 2 drops of the whole blood samples to the sample well on the cassette followed by 1 drop of buffer.
  4. Read results at 5 minutes.
  5. Results read after 20 minutes are considered invalid. Dispose of the cassette safely after testing.


Performance characteristics (RAPG-SPH-002)

  • Relative sensitivity: >99.9%
  • Relative specificity: 99.7%
  • Accuracy: 99.8%

Summary

Syphilis is a disease caused by Spirochete bacterium called Treponema pallidum (Syphilis). If untreated, the organisms move throughout the body and can cause damage to many organs, making syphilis a life-threatening disease if not treated early fully. The serological response to syphilis involves production of antibodies to a wide range of antigens, including non-specific antibodies and specific anti-Syphilis antibodies. The first detectable response to infection is the production of specific anti-treponemal IgM, which can be detected within 4 to 7 days after the chancre appears and until the end of the second week of infection; anti-treponemal IgG appears at about four weeks later. By the time syphilis disease symptoms develop, most patients have both detectable IgG and IgM antibodies.

Principle

The Biopanda Syphilis Rapid Test Cassette is a qualitative membrane based immunoassay for the detection of TP antibodies (IgG and IgM) in whole blood, serum, or plasma. In this test recombinant Syphilis antigen is immobilized in the test line region of the cassette. After specimen is added to the specimen well 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 coloured line will appear in the test line region, indicating a positive result. If the specimen does not contain TP antibodies, a coloured line will not appear in this region, indicating a negative result. To serve as a procedural control, a coloured line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Storage Conditions

+2 - 30 °C




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