DIAKEY Syphilis RAPID

CAT No : PF08

TEST METHOD : Immunochromatographic assay, ICA

INTENDED USE

The Syphilis Antibody Test (Whole Blood/Serum/Plasma) is a rapid detection of antibody to Syphilis Antibody in whole blood, serum or plasma. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

INTENDED USE

Syphilis is a kind of global distribution of sexually transmitted diseases, it almost affects all the organ system of human body, causing seriously damage to the patient's physical and mental health. When human infections Syphilis, it may produce a variety of antibodies, mainly composed of two specificanti leptospira antibodies of IgM and IgG.

Another kind of nonspecific antibody callde reagin, is the antibody produced by the human body when stimulated by the lipid materials released by the histocyte damage by the spirochete, or spirochete itself. These can be test by serological experiment.

PRINCIPLE OF THE ASSAY

The Syphilis Antibody Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay based on the principle of the double antigen–sandwich technique. The membrane is pre-coated with Syphilis recombinant antigen on the test line region of the test. While detecting a positive sample, anti-Syphilis Antibody in the specimen (whole blood, serum or plasma) reacts with the particle coated with anti-SYP antigen. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-SYP antigen on the membrane and generate a coloured line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that the proper volume of specimen has been added and membrane wicking has occurred.