The Syphilis Ultra Rapid Test Device 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.
Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum subspecies pallidum.The Syphilis Ultra Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane device 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 device. After a 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 strip 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.
Add two drops of serum or plasma into the sample window using provided disposable dropper
For Venipuncture Whole Blood specimens: Add 1 drop (20μl) of whole blood to the specimen well (S), then add 2 drops of buffer
For Fingerstick Whole Blood: Allow 1 hanging drop of fingerstick whole blood specimen to fall into the center of the specimen well (S), then add 2 drops of buffer
Wait for the colored band(s) to appear. The result should be read at 20 minutes.
Positive: Two lines appear. One coloured line should be in the control line region (C) and another apparent coloured line should be in the test line region (T).
Negative: One coloured line appears in the control line region(C). No line appears in the test line region (T).
Invalid: No visible band at all or test band without control band.