Department of Blood Transfusion, the Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, Henan, 450008, People's Republic of China.
Joint National Laboratory for Antibody Drug Engineering, Clinical Laboratory of the First Affiliated Hospital, School of Medicine, Henan University, Kaifeng, Henan, 475004, People's Republic of China.
Int J Nanomedicine. 2022 Mar 22;17:1273-1284. doi: 10.2147/IJN.S359541. eCollection 2022.
A rapid, convenient, cost-effective in-home test method for identifying heart-type fatty acid-binding protein (H-FABP) in plasma and blood by a lateral-flow immunoassay (LFIA) based on selenium nanoparticles (SeNPs) was developed.
SeNPs were synthesized by using L-ascorbic acid to reduce seleninic acid at room temperature and conjugated with an anti-H-FABP monoclonal antibody. The limit of detection, specificity, and stability were measured, and clinical samples were analyzed.
The SeNPs were spherical with a diameter of 39.48 ± 3.72 nm and were conjugated successfully with an anti-H-FABP antibody, resulting in a total diameter of 46.52 ± 2.95 nm. The kit was designed for the determination of H-FABP in plasma specimens and whole blood specimens. The limit of detection was 1 ng/mL in plasma and blood, and the results could be determined within 10 min. No cross-reaction occurred with cardiac troponin I, creatine kinase-MB or myoglobin. The kits were stored at 40 °C for up to 30 days without significant loss of activity. The sensitivity was determined to be 100%, the specificity 96.67%, and the overall coincidence rate 97.83%.
This SeNP assay kit can conveniently, rapidly, and sensitively detect H-FABP in plasma or blood with a readout of a simple color change visible to the naked eye with no special device, and can be used as an auxiliary means for the early screening of AMI.
Plasma and blood samples were used under approval from the Experimental Animal Ethics committee of the Joint National Laboratory for Antibody Drug Engineering, Henan University. The clinical trial registration number was HUSOM-2019-047.
开发了一种基于硒纳米粒子（SeNPs）的侧向流免疫分析（LFIA）快速、简便、具有成本效益的在家中检测血浆和血液中心型脂肪酸结合蛋白（H-FABP）的方法。
采用 L-抗坏血酸在室温下还原亚硒酸合成 SeNPs，并与抗 H-FABP 单克隆抗体偶联。测定了检测限、特异性和稳定性，并对临床样本进行了分析。
SeNPs 呈球形，直径为 39.48 ± 3.72nm，成功与抗 H-FABP 抗体偶联，总直径为 46.52 ± 2.95nm。试剂盒用于检测血浆标本和全血标本中的 H-FABP。检测限在血浆和血液中均为 1ng/mL，10min 内即可得出结果。与心肌肌钙蛋白 I、肌酸激酶-MB 或肌红蛋白无交叉反应。试剂盒在 40°C 下储存长达 30 天，活性无明显损失。灵敏度为 100%，特异性为 96.67%，总符合率为 97.83%。
该 SeNP 检测试剂盒可方便、快速、灵敏地检测血浆或血液中的 H-FABP，检测结果为肉眼可见的简单颜色变化，无需特殊设备，可作为 AMI 早期筛查的辅助手段。
河南大学抗体药物工程国家联合实验室实验动物伦理委员会批准使用血浆和血液样本。临床试验注册号为 HUSOM-2019-047。
