颜值测量侧流免疫试验的性能,以评估人体血清囊素C的功能
Xushuo Zhang1, Sam Fishlock1, Peter Sharpe2
1Nanotechnology Integrated Bioengineering Centre (NIBEC), Ulster University, Shore Road, Newtownabbey, County Antrim BT37 0QB, UK.
Biosensors
|July 25, 2025
概括
护理点侧流免疫检测 (LFIA) 通过测量血清酸C (CysC) 来提供慢性病 (CKD) 的早期检测. 这些设备与标准测定结果一致,有助于家庭监测和减少医疗负担.
科学领域:
- 生物医学工程 生物医学工程
- 临床化学 临床化学
- 临床诊断 临床诊断 临床诊断 临床诊断
背景情况:
- 慢性病 (CKD) 与严重的健康问题,如心力衰竭和神经系统疾病有关.
- 早期检测和家庭监测CKD对于患者管理和减少医疗保健系统压力至关重要.
- 血清囊素C (CysC) 是评估功能的一个关键生物标志物.
研究的目的:
- 开发和优化非光侧流免疫试验 (LFIA) 用于在治疗地点 (POC) 检测血清酸C (CysC).
- 评估开发的LFIA与CysC测量的标准罗氏试验的性能.
- 评估LFIA在早期CKD检测和患者自我监测方面的潜力.
主要方法:
- 制造和优化LFIA设备,包括样本体积的变化,膜类型,和金纳米粒子 (AuNP) 特性.
- 对310名患者样本进行分析,以确保统计学有效性.
- 将LFIA结果与使用Bland-Altman图表的标准罗氏试验进行比较.
主要成果:
- 开发的LFIA证明了与罗氏CysC检测标准试验的一致性.
- 布兰德-阿尔特曼分析显示,LFIA结果平均低于罗氏试验的0.51毫克/升,置信区间为95%.
- 在低CysC度 (低于2 mg/L) 的LFIA检测中观察到轻微偏差.
结论:
- 开发的非光LFIA是一种可行的工具,用于检测与标准测试相比的临床CysC水平.
- 尽管在低度下存在轻微偏差,但LFIA可以有效地提醒患者注意早期功能障碍.
- 这种POC测定有助于方便地在家监测CKD,并支持医疗保健专业人员.
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