Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Assessment reagent test results and clinical reference standard statistics
研究概览
简要总结
According to the requirements of the "Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents", the first registered product (hereinafter referred to as the assessment reagent) - Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) was tested in clinical institutions. ) for clinical validation trials. Prove that the clinical performance of the assessment reagent meets the requirements of the intended use.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with peritoneal dialysis due to kidney disease, including those with confirmed peritonitis and those without peritonitis. There are no age or gender requirements, and informed consent is required.
排除标准
- •Patients who have been treated with antibiotics for peritonitis before taking the sample.
- •Incomplete information, including: sample ID number, gender, age, department, clinical diagnosis, sample type, and sampling date.
- •The sample size is insufficient.
- •Repeated cases.
- •The samples whose permeate is red in visual inspection.
结局指标
主要结局
Assessment reagent test results and clinical reference standard statistics
时间窗: 8 months
The peritoneal dialysis effluent collected from the subjects was tested blindly with the assessment reagents, and the test results were compared with the clinical reference standards. By evaluating the clinical sensitivity and specificity of the assessment reagents, the feasibility of clinical application of the assessment reagents was evaluated.
Statistical analysis of non-professional self-testing test
时间窗: 8 months
There is no need to train non-professionals. After reading the instructions and labels, non-professionals can evaluate their ability to understand key information such as instructions and packaging labels through questionnaires; Research, comparison of test results of different forms of reagents, and comparison with professional test results to evaluate their operational capabilities.
次要结局
未报告次要终点