Clinical trial NCT01543295: Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System
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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Syphilis
Keywords: Non-Treponemal
Treponemal
Lead sponsor: Chembio Diagnostic Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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.

Primary outcomes:
measure: Clinical Performance Characteristics
timeFrame: 12 months
Secondary outcomes:
measure: Specimen Types
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Mattel Childrens Hospital, University of California, David Geffen School of Medicine
state: California
city: Fort Lauderdale
country: United States
facility: Therafirst Medical Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Neil T Constantine, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Therafirst Medical Center
name: Anthony LaMarca, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles, David Geffen School of Medicine
name: Neva Yeganeh, M.D.
role: PRINCIPAL_INVESTIGATOR
References: