The Syphilis Rapid Test Cassee(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. Aer specimen is added to the specimen well of the castle, 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 colored line will appear in the test line ( T ), indicating a positive result. If the specimen does not contain TP antibodies, a colored line will not appear in the Test line (T) indicang a Negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that a proper volume of specimen has been added and membrane wicking has occurred.
Syphilis is a curable infection caused by a bacterium called Treponema pallidum. This infection is sexually transmitted, and can also be passed on from a mother to her fetus during pregnancy. As a cause of genital ulcer disease, syphilis has been associated with an increased risk of HIV transmission and acquisition.
Most persons with syphilis tend to be unaware of their infection and they can transmit the infection to their sexual contacts or, in the case of a pregnant woman, to her unborn child. If left untreated, syphilis can cause serious consequences such as stillbirth, prematurity and neonatal deaths. Adverse outcomes of pregnancy are preventable if the infection is detected and treated before mid-second trimester.
Patients with symptoms and signs suggestive of syphilis (e.g. genital ulcer, skin rash) may be treated presumptively, unless appropriate investigations can be performed.
However, since most patients with syphilis have no symptoms or signs, diagnosis relies on a blood test for the detection of antibodies.
For the purposes of this document, a rapid test is a simple point-of-care test that can be used in all health care settings to allow immediate treatment. It is easy to perform and does not require special storage or transport conditions. The result should be easy to interpret and ideally, available in 30 minutes. Most rapid syphilis tests are made in a dipstick or cassette format.
Non-treponemal tests such
as the RPR can be considered
rapid tests as they can provide
a result in less than 10 minutes