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

Chembio Diagnostic Systems, Inc.

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Syphilis

Eligibility

Sex: ALLMin age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

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

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

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).

Time frame: 20 minutes

Data from ClinicalTrials.gov

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