Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01543295
Recruitment Status : Withdrawn
First Posted : March 2, 2012
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.

Brief Summary:
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.

Condition or disease

Detailed Description:

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.

Study Type : Observational
Actual Enrollment : 0 participants
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.
Study Start Date : July 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Syphilis

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…

Primary Outcome Measures :
  1. Clinical Performance Characteristics [ Time Frame: 12 months ]

    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.

Secondary Outcome Measures :
  1. Specimen Types [ Time Frame: 20 minutes ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.

Inclusion Criteria:

  • Must be at least 13 years of age (no upper age limit).
  • Must be willing and able to receive post-test counseling, if applicable.
  • Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
  • Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

  • Persons who are under 13 years of age
  • Persons who are unable to sustain venipuncture (as determined by investigator)
  • Have previously participated in this clinical trial
  • Persons who do not provide an informed consent, or withdraw consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543295

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
Sponsors and Collaborators
Chembio Diagnostic Systems, Inc.
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

Responsible Party: Chembio Diagnostic Systems, Inc. Identifier: NCT01543295     History of Changes
Other Study ID Numbers: CP-SYP-01
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015

Keywords provided by Chembio Diagnostic Systems, Inc.:

Additional relevant MeSH terms:
Treponemal Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female