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

This study has suspended participant recruitment.
(re-evaluating data collection sheet format)
Sponsor:
Information provided by (Responsible Party):
Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier:
NCT01543295
First received: August 8, 2011
Last updated: March 1, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Syphilis

Study Type: Observational
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.

Resource links provided by NLM:

MedlinePlus related topics: Syphilis
U.S. FDA Resources

Further study details as provided by Chembio Diagnostic Systems, Inc.:

Primary Outcome Measures:
  • 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:

    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:
  • 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).


Estimated Enrollment: 915
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)
Groups/Cohorts
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…

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543295

Locations
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.
Investigators
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
  More Information

No publications provided

Responsible Party: Chembio Diagnostic Systems, Inc.
ClinicalTrials.gov Identifier: NCT01543295     History of Changes
Other Study ID Numbers: CP-SYP-01
Study First Received: August 8, 2011
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Chembio Diagnostic Systems, Inc.:
Non-Treponemal
Treponemal

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

ClinicalTrials.gov processed this record on May 19, 2013