title: Rapid and Sensitive Lateral Flow Immunoassay Method for Procalcitonin (PCT) Based on Time-Resolved Immunochromatography.
abstract: Procalcitonin (PCT) is a current, frequently-used marker for severe bacterial infection. The aim of this study was to develop a cost-effective detection kit for rapid quantitative and on-site detection of PCT. To develop the new PCT quantitative detecting kit, a double-antibody sandwich immunofluorescent assay was employed based on time-resolved immunofluorescent assay (TRFIA) combined with lateral flow immunoassay (LFIA). The performance of the new developed kit was evaluated in the aspects of linearity, precision, accuracy, and specificity. Two-hundred thirty-four serum samples were enrolled to carry out the comparison test. The new PCT quantitative detecting kit exhibited a higher sensitivity (0.08 ng/mL). The inter-assay coefficient of variation (CV) and the intra-assay CV were 5.4%-7.7% and 5.7%-13.4%, respectively. The recovery rates ranged from 93% to 105%. Furthermore, a high correlation (n= 234, r = 0.977,p< 0.0001) and consistency (Kappa = 0.875) were obtained when compared with the PCT kit from Roche Elecsys BRAHMS. Thus, the new quantitative method for detecting PCT has been successfully established. The results indicated that the newly-developed system based on TRFIA combined with LFIA was suitable for rapid and on-site detection for PCT, which might be a useful platform for other biomarkers in point-of-care tests.
authors.affiliation: Institute of Antibody Engineering, State Key Laboratory of Organ Failure Research, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou 510515, China. s1002297748@126.com.
authors.forename: Xiang-Yang
authors.initials: XY
authors.lastname: Shao
authors.affiliation: Department of Laboratory Medicine, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China. cynthiawang21@hotmail.com.
authors.forename: Cong-Rong
authors.initials: CR
authors.lastname: Wang
authors.affiliation: Institute of Antibody Engineering, State Key Laboratory of Organ Failure Research, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou 510515, China. plum225@126.com.
authors.forename: Chun-Mei
authors.initials: CM
authors.lastname: Xie
authors.affiliation: R&D Center, DaRui Biotechnology Co., Ltd., Guangzhou 510655, China. 13250293361@163.com.
authors.forename: Xian-Guo
authors.initials: XG
authors.lastname: Wang
authors.affiliation: Institute of Antibody Engineering, State Key Laboratory of Organ Failure Research, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou 510515, China. liang.rongliang@163.com.
authors.forename: Rong-Liang
authors.initials: RL
authors.lastname: Liang
authors.affiliation: Institute of Antibody Engineering, State Key Laboratory of Organ Failure Research, School of Laboratory Medicine and Biotechnology, Southern Medical University, Guangzhou 510515, China. xuson@fimmu.com.
authors.forename: Wei-Wen
authors.initials: WW
authors.lastname: Xu
mesh_terms: D015415:Biomarkers; D002116:Calcitonin; D015740:Calcitonin Gene-Related Peptide; D002846:Chromatography, Affinity; D019095:Point-of-Care Systems; D011498:Protein Precursors
chemical_list: D015415:Biomarkers; D011498:Protein Precursors; D002116:Calcitonin; D015740:Calcitonin Gene-Related Peptide
keywords: immunochromatography; procalcitonin (PCT); time-resolved