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

NCT01543295 | Withdrawn DMC

• 1 other identifier: CP-SYP-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Syphilis

Keywords

Non-Treponemal; Treponemal

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• Specimen Types

  20 minutes

Study Arms (3)

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…

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chembio Diagnostic Systems, Inc.: lead

Study Sites (3)

Mattel Childrens Hospital, University of California, David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

Therafirst Medical Center

Fort Lauderdale, Florida, 33308, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Syphilis

Condition Hierarchy (Ancestors)

Treponemal Infections; Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Neil T Constantine, Ph.D

  University of Maryland, Baltimore

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2011
• First Posted: March 2, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 29, 2015

Record last verified: 2015-07

Locations

US (3)