The ADEXUSDx® Syphilis Test is a rapid immunochromatographic assay used for the qualitative detection of the presence or absence of antibodies to syphilis in human whole blood, plasma, or serum to aid in the diagnosis of Treponema pallidum.
Syphilis is a sexually transmitted disease caused by the bacterium Treponema pallidum. It is transmitted by direct contact with a syphilitic sore, known as a chancre. Syphilis typically follows a progression of stages (primary, secondary, latent, tertiary) with varying symptoms and duration. The primary stage is typically marked by a chancre or chancres at the original site of syphilis infection which subsist for 3-6 weeks before healing. Without treatment, the infection will progress to the secondary stage. Secondary syphilis is marked primarily by skin rashes, and sometimes by swollen lymph nodes, fever, and/or mucous membrane lesions. Like primary syphilis, the symptoms will go away but, without treatment, will progress to the latent stage of disease. During the latent stage, there are no symptoms. Early latent syphilis is specific to infection that occurred within one year. Late latent syphilis is specific to infection that occurred more than one year prior. Latent syphilis can last for years. Tertiary syphilis is rare and develops in a subset of untreated syphilis infections. It can appear decades following primary infection and can affect multiple organ systems, thus symptoms vary. Tertiary syphilis can be fatal.
Syphilis can spread to the brain and nervous system resulting in neurosyphilis and marked by a variety of symptoms including, but not limited to, headache, paralysis, dementia. Syphilis can also spread to the eye resulting in ocular syphilis and marked by changes in vision and even blindness. Women with syphilis can transmit the infection to their babies in utero, resulting in low birth weight babies, and/or early or stillborn deliveries. Untreated babies can become developmentally delayed, have seizures or die.
Diagnosis of syphilis infection relies on both laboratory results and clinical evaluation. Treponema pallidum cannot be cultured on artificial media, however this organism produces both treponemal and non-treponemal antibodies. Therefore, diagnosis of syphilis is made primarily by serologic assays. There are two types of tests available for syphilis: (1) non-treponemal tests and (2) treponemal tests. Non-treponemal tests detect antibodies that are non-specific to syphilis. While non-specific antibodies occur in the majority of syphilis infected individuals, many other conditions can give rise to the same non-specific antibodies resulting in false positives. Treponemal tests detect antibodies specific for syphilis. Treponemal antibodies appear earlier than nontreponemal antibodies and usually remain detectable for life, even post treatment. Both non-treponemal and treponemal tests are needed to confirm diagnosis.
Time to Result: 15 minutes
Result Window: 15-30 minutes
Storage Conditions: 15°C – 30°C (59°F – 86°F ) *Tests do not require refrigeration
Operating Temperature: 15C° – 30°C (59°F – 86°F) *Tests do not require refrigeration
Test Shelf Life: 15 months – expiration dates printed on test pouches Sample
Type(s:): Human venous whole blood, plasma, and serum