Healthcare Technology Innovation Centre, Indian Institute of Technology Madras, Chennai 600113, India.
Department of Chemistry, Carleton University, Ottawa, ON K1S 5B6, Canada.
Sensors (Basel). 2021 May 3;21(9):3178. doi: 10.3390/s21093178.
The diagnosis, prognosis, and control of chronic kidney disease rely on an understanding of the glomerular filtration rate (GFR). The renal clearance of the cystatin-C is closely associated with the GFR. Cystatin-C is a more suitable GFR marker than the commonly used creatinine. General techniques for cystatin-C calculation, such as particle-enhanced turbidimetric and nephelometric assay, are time-consuming and tedious. Here, we propose a rapid, quantitative immunoassay for the detection of cystatin-C. A fluorescence-based lateral-flow kit was developed in a sandwich format by using a monoclonal antibody. A Linear calibration was obtained over the clinical diagnostic range of 0.023-32 µg/mL and the limit of detection (LOD) was 0.023 µg/mL and the limit of quantification (LOQ) was 0.029 µg/mL. Average recoveries from spiked urine samples ranged from 96-100% and the coefficient of variation was less than 4% for both intra and inter-day assays with excellent repeatability. With the comparison with an ELISA kit, the developed kit is highly sensitive, performs well over the detection range, provides repeatable results in a short time, and can easily be used at point-of-care (POC), making it an ideal candidate for rapid testing in early detection, community screening for renal function disorders.
慢性肾脏病的诊断、预后和控制依赖于对肾小球滤过率（GFR）的理解。胱抑素 C 的肾清除率与 GFR 密切相关。胱抑素 C 比常用的肌酐更适合作为 GFR 标志物。胱抑素 C 的一般计算技术，如颗粒增强比浊法和散射比浊法，既耗时又繁琐。在这里，我们提出了一种用于检测胱抑素 C 的快速定量免疫分析法。采用单克隆抗体，以三明治形式开发了基于荧光的侧向流动试剂盒。在 0.023-32 µg/mL 的临床诊断范围内获得了线性校准，检测限（LOD）为 0.023 µg/mL，定量限（LOQ）为 0.029 µg/mL。从尿液样本中添加的胱抑素 C 的平均回收率在 96-100%之间，日内和日间测定的变异系数均小于 4%，重复性极好。与 ELISA 试剂盒相比，该试剂盒具有高灵敏度，在检测范围内表现良好，在短时间内提供可重复的结果，并且可以轻松在床边（POC）使用，使其成为早期检测、肾功能障碍社区筛查的快速检测的理想候选者。
