ALPCO Syphilis-T (Treponema Pallidum) CLIA Kit and ALPCO Syphilis-NT (Non-Treponemal Lipoidal Antigen) CLIA Kit Blood Donation Protocol
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Blood Specimens Successfully Processed Into Serum
研究概览
简要总结
This prospective, single-center study will collect blood from approximately 50 adult volunteers aged 22 years or older. Participants will provide informed consent, complete an eligibility review, and undergo one blood draw of approximately 20-50 mL.
The blood will be processed into serum and labeled with a study identification number. The serum may be used to prepare laboratory samples with defined antibody levels to support the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays. All testing is for research purposes only. Individual test results will not be provided to participants or used for diagnosis or treatment.
详细描述
Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum. Laboratory diagnosis commonly includes treponemal tests, which detect antibodies specific to T. pallidum, and non-treponemal tests, which detect antibodies associated with cellular damage and may help assess disease activity.
Serum collected under this study will serve as a human serum matrix for preparing contrived specimens. These specimens may be created by adding characterized reactive serum or other appropriately characterized materials to produce predefined levels of treponemal or non-treponemal reactivity. Before use, the serum may be evaluated using appropriate reference or comparator methods to confirm its suitability.
The resulting specimens will support analytical and, when scientifically and regulatorily appropriate, clinical performance evaluations of the ALPCO Syphilis-T and Syphilis-NT assays. The specific preparation procedures, target reactivity levels, testing methods, and acceptance criteria will be defined in the applicable performance-study protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adults aged 22 years or older Able and willing to provide written informed consent Able and willing to provide a blood sample in accordance with the protocol
排除标准
- •Unable or unwilling to provide written informed consent Unable or unwilling to undergo venipuncture Any medical condition that would make blood collection unsafe, as determined by study personnel
研究组 & 干预措施
Adult Volunteer Blood Donors
Adult volunteers aged 22 years or older who provide one blood sample for serum collection and research use.
干预措施: ALPCO Syphilis-T (Device)
Adult Volunteer Blood Donors
Adult volunteers aged 22 years or older who provide one blood sample for serum collection and research use.
干预措施: ALPCO Syphilis-NT CLIA Kits (Device)
结局指标
主要结局
Number of Blood Specimens Successfully Processed Into Serum
时间窗: Day 1, following the single study visit and serum processing
The number of enrolled participants from whom approximately 20-50 mL of whole blood is successfully collected and processed into serum suitable for research use in the development and performance evaluation of the ALPCO Syphilis-T and Syphilis-NT assays.
次要结局
未报告次要终点