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

Withdrawn before enrolling

Conditions studied: Syphilis

In brief

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.

Key facts

Study ID

NCT01543295

Run by

Chembio Diagnostic Systems, Inc.

People needed

0

Starts

2011-07-01

Expected to finish

2012-12-01

Last updated by the study team

2015-07-29

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Mattel Childrens Hospital, University of California, David Geffen School of Medicine — Los Angeles, California, United States
• Therafirst Medical Center — Fort Lauderdale, Florida, United States
• University of Maryland — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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