NCT05981495尚未招募不适用
Clinical Evaluation of the NanoDetect-TB Mycobacterium Tuberculosis Detection Kit for the Diagnosis of Tuberculosis Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 460
- 主要终点
- NanoDetect-TB result compared to sputum culture
研究概览
简要总结
The goal of this observational study is investigate the accuracy of the NanoDetect-TB kit in diagnosing tuberculosis (TB) using frozen serum and plasma samples collected from individuals suspected to have TB disease.
The main question[s] it aims to answer are:
- How does this investigational device compare to the gold standard for TB diagnosis of sputum culture?
- How does it compare to Acid-Fast Bacteria (AFB) smear microscopy and FDA-approved NAAT TB diagnostic assays?
Participants will be asked to have blood drawn and provide demographic and medical data for this study in a single visit.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adults aged two years or older (including older adults that are 65+)
- •Ability and willingness to provide informed consent/assent/permission, and a parent/legal guardian willing to give consent on the child's behalf for study participants aged 2-17 years
- •Ability and willingness to perform study procedures, or parent/legal guardian to provide consent for a child to undergo study procedures on their behalf (when applicable)
- •Clinical signs and symptoms typically associated with active TB disease including, but not limited to:
- •Cough for > two (2) weeks Lethargy, weakness, malaise Reduced playfulness (pediatric population) Weight loss or loss of appetite Failure to thrive (pediatric population) Fever Chest pain Night sweats
- •Physician (or healthcare provider) suspicion of TB disease
排除标准
- •Pregnancy (based on participant-provided information)
- •Any physical or mental health condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject and/or prevent, limit, or confound protocol-specified procedures
- •Critical illness needing immediate medical care
- •Receipt of treatment for active TB or LTBI in the past 24 months
结局指标
主要结局
NanoDetect-TB result compared to sputum culture
时间窗: Single visit for patient for blood draw.
The investigational device results will be compared to the primary reference of sputum culture for determining relative sensitivity and specificity.
次要结局
- NanoDetect-TB result compared to AFB Smear and NAAT(Single visit for patient for blood draw.)
研究者
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