Evidence map›Paper›PMID 41774187›Full record

ArticleMikrochimica acta2026

Development of a monoclonal antibody-based time-resolved fluorescence immunochromatographic assay strip for rapid and quantitative determination of ubiquitin C-terminal hydrolase L1 in serum.

Wenjie Guo, Tianxu Li, Yonghua Chen, Wenyi Lin, Zhiyuan Wang, Kangjie He, Houfeng Zhou, Rui Feng, Zhenye Zhan, Xiao Cheng and 4 more

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Article in Mikrochimica acta, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

14 authors.

Wenjie Guo *School of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Tianxu Li *School of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Yonghua Chen *The Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Wenyi LinSchool of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Zhiyuan WangSchool of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Kangjie HeSchool of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Houfeng ZhouThe Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Rui FengSchool of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China.
Zhenye ZhanThe Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Xiao ChengChinese Medicine Guangdong Laboratory, State Key Laboratory of Traditional Chinese Medicine Syndrome, Guangdong Provincial Key Laboratory of Research on Emergency in TCM, The Second Affiliated Hospital of Guangzhou, University of Chinese Medicine, Guangzhou, Guangdong, China.
Jing HeUniversity of Queensland, Brisbane, QLD, Australia.
Andre Van ZundertUniversity of Queensland, Brisbane, QLD, Australia.
Jianfen SuThe Affiliated Panyu Central Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
Jie ZanSchool of Biomedical and Pharmaceutical sciences, Guangdong University of Technology, Guangzhou, Guangdong, China. zanj@gdut.edu.cn.

Funding

Technology Research and Development Project of Traditional Chinese Medicine Guangdong Laboratory HQL2024PZ013
6 · The paper itself

Abstract

Traumatic brain injury (TBI) represents a major global health challenge requiring rapid and accurate diagnostic tools. Current detection methods for ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1), a neuron-specific biomarker with diagnostic significance at serum concentrations exceeding 327 pg/mL, face limitations in operational complexity and equipment dependency. Herein, we report the development of a monoclonal antibody-based time-resolved fluorescence immunochromatographic assay strip (TRFIA) for rapid and quantitative determination of UCH-L1 in serum. High-affinity antibody pairs were generated via hybridoma technology, and time-resolved fluorescent microspheres (TRFMs) were integrated with lateral flow immunoassay to overcome the limitations of conventional lateral flow platforms. The optimized TRFIA strip demonstrated excellent analytical performance with a linear range of 0.195–12.5 ng/mL (R² = 0.98), a low limit of detection (LOD) of 81.1 pg/ml, and a rapid assay time of 15 min. Intra- and inter-batch coefficients of variation were consistently below 10%, confirming exceptional reproducibility. Specificity analysis revealed minimal cross-reactivity with other TBI-related biomarkers (Tau, S100β, GFAP). Clinical validation using 24 serum samples from mTBI patients and 10 healthy controls demonstrated significant UCH-L1 elevation in TBI cases (AUC = 0.95), confirming the assay’s diagnostic capability. This TRFIA platform offers a portable, cost-effective, and user-friendly solution for point-of-care TBI diagnosis, particularly valuable in resource-limited settings where rapid decision-making is critical. The development represents a significant advancement in TBI diagnostics, providing a complementary tool to enhance diagnostic accuracy while minimizing unnecessary radiation exposure from CT scans.

Indexed as

Antibodies, MonoclonalChromatography, AffinityUbiquitin ThiolesteraseAnimalsBiomarkersBrain Injuries, TraumaticFluorescenceHumansImmunoassayLimit of DetectionMiceMicrospheresRapid Diagnostic TestsAntibodies, MonoclonalBiomarkersUbiquitin ThiolesteraseUCHL1 protein, humanNeuron-specific biomarkerTime-resolved fluorescent microspheresTraumatic brain injuryUbiquitin carboxyl-terminal hydrolase L1

Identifiers

PMID41774187

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.