Development of a fluorescence immunochromatography method for quantitative measurement of matrix metalloproteinase-9

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY Practical Laboratory Medicine Pub Date : 2024-01-01 DOI:10.1016/j.plabm.2024.e00356
Jingyan Huang , Cuicui Chen , Huankun Liang , Wenqi Dong , Laiqing Li , Hongyan Ma
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Abstract

Objective

Abnormal serum matrix metalloproteinase-9 (MMP-9) levels are closely related to the occurrence and development of many diseases. This study aimed to establish a fluorescence immunochromatography (FIC) method using the lanthanide fluorescent element europium(III) (Eu3+) for the quantitative measurement of MMP-9 in serum.

Design & Methods

The FIC method for quantifying MMP-9 was optimized and established, and the FIC test strips (FICTS) were assembled and subsequently evaluated for sensitivity, specificity and precision. Furthermore, the reference interval and clinical sensitivity/specificity were estimated using clinical healthy/positive serum samples, and a commercial ELISA was used for comparison.

Results

We successfully established an FIC method and prepared FICTS. The analytical sensitivity of the FICTS was 0.92 ng/mL, with a linearity range of 0–1000 ng/mL. The cross-reactivity of the 7 common serum interferents was less than 1.56%. All recoveries of the intra-array and inter-array samples ranged from 102.50% to 110.99%, and all CVs were less than 5%. The reference interval of the FICTS was >161.15 ng/mL. The clinical sensitivity was 96.00%, and the specificity was 97.5%. The results of 270 clinical serum samples were highly coincident with the clinical diagnostic results. Pearson correlation analysis and Bland‒Altman plots indicated that the FICTS and commercial ELISA results were consistent with the quantitative MMP-9 concentration.

Conclusions

The designed FIC method and test strips may be suitable for point-of-care quantitative measurement of MMP-9, which provides a new method for screening for atherosclerosis, xerophthalmia, etc.

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开发一种荧光免疫层析方法,用于定量检测基质金属蛋白酶-9
目的血清基质金属蛋白酶-9(MMP-9)水平异常与多种疾病的发生和发展密切相关。本研究旨在建立一种使用镧系荧光元素铕(III)(Eu3+)的荧光免疫层析(FIC)方法,用于定量检测血清中的MMP-9。设计与amp; 方法优化并建立了定量检测MMP-9的FIC方法,并组装了FIC试纸条(FICTS),随后对其灵敏度、特异性和精确度进行了评估。结果我们成功地建立了一种 FIC 方法并制备了 FICTS。FICTS 的分析灵敏度为 0.92 ng/mL,线性范围为 0-1000 ng/mL。7种常见血清干扰物的交叉反应率小于1.56%。所有阵列内和阵列间样品的回收率范围为 102.50% 至 110.99%,所有 CV 均小于 5%。FICTS 的参考区间为 161.15 ng/mL。临床灵敏度为 96.00%,特异性为 97.5%。270 份临床血清样本的结果与临床诊断结果高度吻合。结论 所设计的 FIC 方法和试纸条可能适用于 MMP-9 的床旁定量检测,为动脉粥样硬化、干眼症等疾病的筛查提供了一种新方法。
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来源期刊
Practical Laboratory Medicine
Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology
CiteScore
3.50
自引率
0.00%
发文量
40
审稿时长
7 weeks
期刊介绍: Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.
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