title: Rapid and sensitive lateral flow immunoassay method for determining alpha fetoprotein in serum using europium (III) chelate microparticles-based lateral flow test strips.
abstract: Alpha-fetoprotein (AFP), a primary marker for many diseases including various cancers, is important in clinical tumor diagnosis and antenatal screening. Most immunoassays provide high sensitivity and accuracy for determining AFP, but they are expensive, often complex, time-consuming procedures. A simple and rapid point-of-care system that integrates Eu (III) chelate microparticles with lateral flow immunoassay (LFIA) has been developed to determine AFP in serum with an assay time of 15 min. The approach is based on a sandwich immunoassay performed on lateral flow test strips. A fluorescence strip reader was used to measure the fluorescence peak heights of the test line (HT) and the control line (HC); the HT/HC ratio was used for quantitation. The Eu (III) chelate microparticles-based LFIA assay exhibited a wide linear range (1.0-1000 IU mL(-1)) for AFP with a low limit of detection (0.1 IU mL(-1)) based on 5ul of serum. Satisfactory specificity and accuracy were demonstrated and the intra- and inter-assay coefficients of variation (CV) for AFP were both <10%. Furthermore, in the analysis of human serum samples, excellent correlation (n = 284, r = 0.9860, p < 0.0001) was obtained between the proposed method and a commercially available CLIA kit. Results indicated that the Eu (III) chelate microparticles-based LFIA system provided a rapid, sensitive and reliable method for determining AFP in serum, indicating that it would be suitable for development in point-of-care testing.
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Rong-Liang
authors.initials: RL
authors.lastname: Liang
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Xu-Ping
authors.initials: XP
authors.lastname: Xu
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Tian-Cai
authors.initials: TC
authors.lastname: Liu
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Jian-Wei
authors.initials: JW
authors.lastname: Zhou
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Xian-Guo
authors.initials: XG
authors.lastname: Wang
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China.
authors.forename: Zhi-Qi
authors.initials: ZQ
authors.lastname: Ren
authors.affiliation: DaAn Gene Co. Ltd. of Sun Yat-sen University, 19 Xiangshan Road, Guangzhou 510515, PR China.
authors.forename: Fen
authors.initials: F
authors.lastname: Hao
authors.affiliation: Institute of Antibody Engineering, School of Biotechnology, Southern Medical University, Guangzhou 510515, Guangdong, PR China. Electronic address: wg@smu.edu.cn.
authors.forename: Ying-Song
authors.initials: YS
authors.lastname: Wu
mesh_terms: D002614:Chelating Agents / Q000737:chemistry*; D004867:Equipment Design; D005063:Europium / Q000737:chemistry*; D015200:Fluoroimmunoassay / Q000191:economics / Q000295:instrumentation*; D006801:Humans; D057230:Limit of Detection; D019095:Point-of-Care Systems; D011934:Reagent Strips / Q000032:analysis*; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: D002614:Chelating Agents; D011934:Reagent Strips; D000509:alpha-Fetoproteins; D005063:Europium
keywords: Alpha-fetoprotein; Eu (III) chelate microparticles; Fluorescence lateral flow immunoassay; Point-of-care