跳至主要内容
临床试验/NCT01543295
NCT01543295撤回不适用

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.

Chembio Diagnostic Systems, Inc.3 个研究点 分布在 1 个国家开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
3
主要终点
Clinical Performance Characteristics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Clinical Performance Characteristics

时间窗: 12 months

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.

次要结局

  • Specimen Types(20 minutes)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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