Tunakhun Paweena, Ngernpimai Sawinee, Tippayawat Patcharaporn, Choowongkomon Kiattawee, Anutrakulchai Sirirat, Charoensri Nicha, Tavichakorntrakool Ratree, Daduang Sakda, Srichaiyapol Oranee, Maraming Pornsuda, Boonsiri Patcharee, Daduang Jureerut
Biomedical Sciences, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand.
Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand.
ACS Omega. 2024 Aug 12;9(34):36475-36484. doi: 10.1021/acsomega.4c04322. eCollection 2024 Aug 27.
The incidence of kidney disease is increasing worldwide. Rapid and cost-effective approaches for early detection help prevent this disease. Neutrophil gelatinase-associated lipocalin protein (NGAL) is a novel biomarker for acute kidney injury (AKI) and chronic kidney disease (CKD). We aimed to develop a lateral flow strip (LFS) based on a lateral flow immunoassay method (LFIA), using latex microspheres (LMs) as a color labeling to detect NGAL in urine. The performance and potential of the developed LMs-LFS at a point-of-care (POC) testing were evaluated. The results showed that LMs-LFS successfully detected urinary NGAL within 15 min with high specificity without cross-reactivity to or interference from other endogenous substances in urine. The visual limit of detection (vLOD) was 18.75 ng/mL, and the limit of detection (LOD) was 1.65 ng/mL under the optimum condition. The LMs-LFS developed in this study showed a high correlation with the enzyme-linked immunosorbent assay (ELISA) method ( = 0.973, = 60 urine specimens) for detecting NGAL in urine. The LMs-LFS remained stable for at least six months at room temperature. The LMs-LFS can be a rapid, sensitive, and specific tool for the diagnosis and follow-up of renal disorders at the POC.
全球范围内，肾脏疾病的发病率正在上升。早期检测的快速且经济高效的方法有助于预防这种疾病。中性粒细胞明胶酶相关脂质运载蛋白（NGAL）是急性肾损伤（AKI）和慢性肾病（CKD）的一种新型生物标志物。我们旨在基于侧向流动免疫分析方法（LFIA）开发一种侧向流动试纸条（LFS），使用乳胶微球（LMs）作为颜色标记来检测尿液中的NGAL。评估了所开发的LMs-LFS在即时检测（POC）中的性能和潜力。结果表明，LMs-LFS在15分钟内成功检测出尿液中的NGAL，特异性高，对尿液中其他内源性物质无交叉反应或干扰。在最佳条件下，视觉检测限（vLOD）为18.75 ng/mL，检测限（LOD）为1.65 ng/mL。本研究中开发的LMs-LFS与酶联免疫吸附测定（ELISA）方法在检测尿液中NGAL方面具有高度相关性（r = 0.973，n = 60份尿液标本）。LMs-LFS在室温下至少可稳定保存六个月。LMs-LFS可成为POC中用于肾脏疾病诊断和随访的快速、灵敏且特异的工具。
