ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits
研究概览
简要总结
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.
详细描述
This is a multicenter, prospective clinical collection study designed to evaluate the diagnostic performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits. The study will enroll individuals undergoing routine syphilis testing, those with a history of syphilis, HIV-positive individuals, pregnant individuals, and healthy volunteers. Blood samples will be collected, processed, and tested across up to three clinical sites using the investigational kits. Reference results will be determined using validated, FDA-cleared treponemal and non-treponemal tests. For the treponemal assay, results will be considered accurate if they match at least two of the three reference tests. The primary objective is to demonstrate that both kits meet or exceed prespecified performance criteria, including ≥95% positive and negative percent agreement (≥99% NPA for the non-treponemal kit), with the lower bound of the 95% confidence interval at or above 90%.
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
- 是
入选标准
- •Male, Female, or Other(s)
- •Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory.
- •Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician.
- •Pregnant individuals and children (under 22): 1 clinical study tube of blood.
- •All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood.
- •Participants must be able and willing to sign the informed consent form (ICF).
- •Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.
排除标准
- •Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days
- •Patients with pre-existing conditions that would make blood collection difficult or harmful
- •If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.
- •Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.
研究组 & 干预措施
Syphilis-Positive Patients
Individuals with a current or prior diagnosis of syphilis.
干预措施: ALPCO Syphilis-T (Device)
Syphilis-Positive Patients
Individuals with a current or prior diagnosis of syphilis.
干预措施: ALPCO Syphilis-NT CLIA Kits (Device)
HIV-Positive Patients
Individuals diagnosed with HIV (may or may not overlap with other cohorts).
干预措施: ALPCO Syphilis-T (Device)
HIV-Positive Patients
Individuals diagnosed with HIV (may or may not overlap with other cohorts).
干预措施: ALPCO Syphilis-NT CLIA Kits (Device)
Pregnant Individuals
Pregnant participants across all trimesters.
干预措施: ALPCO Syphilis-T (Device)
Pregnant Individuals
Pregnant participants across all trimesters.
干预措施: ALPCO Syphilis-NT CLIA Kits (Device)
Apparently Healthy Individuals
Participants with no known history or symptoms of syphilis.
干预措施: ALPCO Syphilis-T (Device)
Apparently Healthy Individuals
Participants with no known history or symptoms of syphilis.
干预措施: ALPCO Syphilis-NT CLIA Kits (Device)
结局指标
主要结局
Positive and Negative Percent Agreement of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits
时间窗: 6 months
Evaluate the clinical performance of the ALPCO Syphilis-T and Syphilis-NT CLIA Kits in detecting antibodies to Treponema pallidum and lipoidal antigens, by comparing results against established comparator assays. Success is defined as meeting or exceeding pre-specified thresholds for Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), with lower bounds of the 95% confidence interval ≥90%.
次要结局
未报告次要终点