An observational study in Syphilis, sponsored by Chembio Diagnostic Systems, Inc.. Withdrawn at 3 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-29.
Sponsored by Chembio Diagnostic Systems, Inc. · Observational
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.
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 [1].
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.
120 studies on the registry are indexed under Syphilis; 33 are open to participants now.
Browse Syphilis studies →Chembio Diagnostic Systems, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from study sites at diverse geographical locations in the United States. Such sites include primary care clinics, Obstetric/Gynecology clinics, physician offices, hospitals.
Exclusion Criteria:
Individuals known to have a clinical diagnosis of Syphilis
Individuals with previous and confirmed STD infection, MSM, persons with high risk sexual behavior or clinical examination with classic manifestations of syphilis.
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...
Clinical Performance Characteristics
Support the claims that the DPP Syphilis Screen and Confirm test system is: 1. substantially equivalent to a recognized laboratory method for syphilis presumptive screening tests, and 2. substantially equivalent to a recognized laboratory method for syphilis confirmatory tests.
Time frame: 12 months
Specimen Types
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).
Time frame: 20 minutes
This study is withdrawn, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chembio Diagnostic Systems, Inc.