Development of a Point-of-Care Test Based on Selenium Nanoparticles for Heart-Type Fatty Acid-Binding Proteins in Human Plasma and Blood

Abstract

Lanju Wang,1,2,* Mengli Wu,2,* Jingjing Ma,2,* Ziwei Ma,2 Jiahui Liang,2 Ningya Tao,2,3 Yangguang Ren,4 Shujun Shao,1 Xin Qi,1 Zhizeng Wang2 1Department of Blood Transfusion, the Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, Henan, 450008, People’s Republic of China; 2Joint 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; 3Pingyu Health School, Zhumadian, Henan, 463400, People’s Republic of China; 4Breast and Thyroid Surgery, Huaihe Hospital of Henan University, Kaifeng, Henan, 475004, People’s Republic of China*These authors contributed equally to this workCorrespondence: Xin Qi, Department of Blood Transfusion, the Affiliated Tumor Hospital of Zhengzhou University, Zhengzhou, 450008, People’s Republic of China, Tel [phone], Email [email protected] Zhizeng Wang, 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, Tel [phone], Email [email protected]: 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.Methods: 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.Results: 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%.Conclusion: 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.Clinical Trial Registration: 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.Keywords: heart-type fatty acid-binding protein, selenium nanoparticle, lateral-flow immunoassay, point-of-care test, blood

Keywords

• heart-type fatty acid-binding protein
• selenium nanoparticle
• lateral-flow immunoassay
• point-of-care test
• blood