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

Syphilis Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01543295
• Other study ID #: CP-SYP-01
• Status: Withdrawn
• Phase: N/A
• First received: August 8, 2011
• Last updated: July 27, 2015
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Chembio Diagnostic Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Syphilis

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Therafirst Medical Center	Fort Lauderdale	Florida
United States	Mattel Childrens Hospital, University of California, David Geffen School of Medicine	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Chembio Diagnostic Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Performance Characteristics	Support the claims that the DPP Syphilis Screen and Confirm test system is: substantially equivalent to a recognized laboratory method for syphilis presumptive screening tests, and; substantially equivalent to a recognized laboratory method for syphilis confirmatory tests.	12 months	No
Secondary	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).	20 minutes	No