The Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) 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. A rapid test for the qualitative detection of antibodies (IgG and IgM) to Treponema Pallidum (TP) in whole blood, serum or plasma, as an aid in the diagnosis of Syphilis. For professional in vitro diagnostic use only.
The Syphilis Ultra Rapid Test Strip (Whole Blood/Serum/Plasma) 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 a specimen is added to the specimen pad it reacts with Syphilis antigen coated particles that have been applied to the specimen pad. 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. If the control line does not appear, the test result is not valid.