Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System
This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® Syphilis Screen and Confirm rapid test. The device is intended to qualitatively and simultaneously detect the presence of antibodies to Non-treponemal and Treponema pallidum antigens in whole blood (capillary and venous), serum or plasma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Qualitative Evaluation of the DPP Syphilis Screen and Confirm Rapid Test to Detect the Presence of Antibodies Against Non-Treponemal and Treponema Pallidum Antigens in Fingerstick Whole Blood, Venous Whole Blood, Serum and Plasma Specimens.|
- Clinical Performance Characteristics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Support the claims that the DPP Syphilis Screen and Confirm test system is:
- substantially equivalent to a recognized laboratory method for syphilis presumptive screening tests, and
- substantially equivalent to a recognized laboratory method for syphilis confirmatory tests.
- Specimen Types [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]The device detects specific antibodies to Non-Treponema and Treponema pallidum antigens in a variety of sample matrices: capillary whole blood, venous whole blood (with EDTA or heparin anticoagulant),serum and plasma (with EDTA or heparin anticoagulant).
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Known Positive Syphilis Infection
Individuals known to have a clinical diagnosis of Syphilis
High Risk for Syphilis Infection
Individuals with previous and confirmed STD infection, MSM, persons with high risk sexual behavior or clinical examination with classic manifestations of syphilis.
Pregnant Women (High Risk and Low Risk)
1st or 3rd trimester from either High Risk (see description above) or Low Risk population.
Low Risk are individuals not known to belong to any of the defined high-risk groups - i.e. "healthy patients" presenting for routine physicals or other unrelated non-life threatening illnesses, or individuals from a general low risk population such as students, employees of academic or other institutions, etc…
Syphilis is a sexually transmitted disease (STD) caused by the spirochete Treponema pallidum. It is a chronic bacterial infection that remains a public health concern worldwide, especially in resource poor settings. Syphilis can be transmitted from infected women to their unborn children during pregnancy. Worldwide 12 million individuals are diagnosed with syphilis each year, 90% of them in developing countries. Diagnosed individuals are also at risk of becoming infected with and transmitting HIV .
Early and appropriate diagnosis and treatment prevents the transmission and development of severe complications. A rapid serologic test for specific antibodies to non-Treponemal and T. pallidum antigens is important in the early diagnosis and treatment monitoring of syphilis patients. In turn, this monitoring allows for the formulation of a more successful public health strategy. Various serologic tests are currently available such as Venereal Disease Research Laboratory (VDRL), rapid plasma reagin (RPR), fluorescent Treponemal antibody absorption (FTA-ABS) test, T. pallidum hemagglutination (TPHA) test, immunoenzymatic assay (EIA), Treponema pallidum particle agglutination (TPPA) test and Western blot (WB) test [2- 5]. The Chembio DPP Syphilis Screen & Confirm Assay is a unique non-Treponemal and Treponemal rapid point-of-care test, which is simple and easy to use. The DPP Syphilis Screen & Confirm Assay is a qualitative immunoassay for the detection of antibodies to the non-Treponemal and T. pallidum antigens in serum, plasma and whole blood.
|United States, California|
|Mattel Childrens Hospital, University of California, David Geffen School of Medicine|
|Los Angeles, California, United States, 90095|
|United States, Florida|
|Therafirst Medical Center|
|Fort Lauderdale, Florida, United States, 33308|
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Neil T Constantine, Ph.D||University of Maryland|
|Principal Investigator:||Anthony LaMarca, M.D.||Therafirst Medical Center|
|Principal Investigator:||Neva Yeganeh, M.D.||University of California, Los Angeles, David Geffen School of Medicine|