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Syphilis Rapid Test CE Marking


Product Number: RAPG-SPH-001 (Serum, Plasma)
Product Number: RAPG-SPH-002 (Serum, Plasma, Whole Blood)

Pack size

20 tests

Product Description

The Biopanda Syphilis One Step Rapid test qualitatively detects for the presence of antibodies IgG and IgM to Treponema Pallidum (Syphilis) in human serum or plasma samples. This test applies lateral flow immuno-chromatography and is for professional in vitro diagnostic use.

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 One Step Rapid Test is a lateral flow chromatographic immunoassay based on the principle of the double antigen-sandwich technique. In this test , recombinant Syphilis Recombinant antigen is immobilized in the test line region of the strip. After the sample is added to the well of the device, it reacts with Syphilis Recombinant antigen coated particles in the test strip. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized Syphilis antigens. If the sample contains Syphilis antibodies, a coloured line will appear in the test line region indicating a positive result. If the specimen does not contain Syphilis 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.

Storage Conditions

+2 - 30 °C




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