DPP® Syphilis Screen & Confirm |
DPP® Syphilis Screen & Confirm*
Product Information
Syphilis, caused by the bacterial spirochete Treponema pallidum, is a significant source of human morbidity and mortality worldwide. In fact, it is estimated that there are over 12 million cases of syphilis occurring worldwide every year. In the United States syphilis has a storied history. With an incidence great enough to instigate its own (and one of the earliest) specialized medical journals (American Journal of Syphilis, Gonorrhea and Venereal Disease), syphilis reached its peak incidence in the early 1940’s (approx. 450/100,000 population) and gradually tapered off over the subsequent 60 years, with a small spike in incidence during the late 1980’s. Recently the United States Centers for Disease Control (CDC) estimated an all time low in syphilis incidence in 2000, but more importantly the CDC has seen a steady increase in reported cases since then. Discussion with regards to causative factors of this rise in incidence can be found below.
Given the historical context of syphilis in humans as well the sequelae of pathological features if left untreated (including congenital syphilis of the new born), widespread guidelines have been implemented that take into account both disease progression and epidemiology.
Infection with syphilis leads to one of four clinical scenarios.
Primary Syphilis – Typical presentation is a painless genital lesion that heals spontaneously with 1 to 6 weeks.
Secondary syphilis – Typical presentation is a generalized skin manifestation, such as rash or other lesions that may persist for months.
Latent syphilis – Typically no clinical manifestations.
Tertiary syphilis – Typically occurring in untreated cases that has the potential for a wide range of systemic manifestations effecting a wide range of organ systems such as cardiac, neurologic, skeletal, and skin.
In women, infection with syphilis at any stage can be transmitted to the developing fetus with devastating consequences. For this reason current recommendations state all pregnant women to be screened for antibodies directed against T. pallidum during their first prenatal visit.
Recent data from 2007 epidemiologic studies suggest an overall syphilis incidence of 3.7/100,000 in the U.S. This number represents an overall increase of 12% from recent years and is believed to be concentrated, for the most part, in a subset group representing men who have sex with men (MSM). Extrapolation of this data suggests approximately 70,000 new cases of syphilis occurring in the U.S. annually, with a male:female ratio of 3.5:1.
Syphilis remains a significant global public health problem with the World Health Organization (WHO) estimating 12 million new cases of the disease worldwide each year including 100,000 per year in the United States and 140,000 per year in Western Europe.
DPP® Screen & Confirm provides the most conclusive evidence, at the point-of-care (POC), of active, untreated disease as compared with current methods, thereby enabling diagnosis and treatment in a single visit to a clinic.
Standard diagnosis of syphilis is currently done using two different laboratory-based serologic tests, namely a non-treponemal screening test, usually either the Rapid Plasma Reagin (RPR) or Venereal Disese Research Laboratory (VDRL), followed by a more specific treponemal confirmatory (EIA) assay. Chembio has developed the first dual non-treponemal & treponemal POC syphilis test.
Utilizing Chembio’s patented Dual Path Platform technology, DPP® Screen & Confirm permits the simultaneous yet separate detection of both markers at the point of care. The test, which will be eligible for a CLIA waiver (Clinical Laboratory Improvement Act waiver allows use in point of care settings of simple to use tests), therefore represents a considerable advance in diagnosis as well as in time to result and ease of use.
Assay Features:
- Convenient & Cost Effective
- Ideally suited for field and point-of-care testing
- Minimal sample size required—10 µl whole blood, 5 µl serum or plasma
- Room temperature storage
- Long shelf life
- Time & Labor Saving
- Simple, two-step procedure
- Total test time of 15 minutes
- No special equipment required
- Reliable Results
- Built-in IgG procedural control Highly sensitive and specific
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