A novel Schirmer strip-based tear matrix metalloproteinase measurement in dry eye evaluation

IF 5.9 1区医学 Q1 OPHTHALMOLOGY

Ocular Surface Pub Date : 2025-01-15 DOI:10.1016/j.jtos.2025.01.004

Di Chen , Wubi Li , Shan Yang , Hang Song , Yu Di , Weixing Zhong , Miao Zhang , Qin Long , Ying Li , Chan Zhao

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引用次数: 0

Abstract

Purpose

The diagnosis and evaluation of dry eye require easy-to-use, precise, and consistent tools in clinical setting. Matrix metalloproteinase 9 (MMP-9) has been proven to be a reliable indicator of dry eye inflammation. The aim of this study is to establish an Eu-time resolved fluorescence immunochromatography (Eu-TRFICO) method for quantitative detection of MMP-9 in human tear based upon widely used Schirmer strips.

Methods

The Eu-TRFICO method for Schirmer strip-based tear MMP-9 measurements were optimized and assembled. The sensitivity, repeatability and homogeneity were evaluated using MMP-9 standard dilutions. The diagnostic and treatment monitoring performance were evaluated in both dry eye patients and normal subjects.

Results

The standard curve equation was y = 0.0037 + 8.0692/[1+ (x/188.322)^−0.8972] (R2 = 0.99998), and the sensitivity was 0.25 ng/mL. The Schirmer strip-based MMP-9 measurements showed acceptable repeatability and homogeneity with different saturation length in both low and high standard solutions. A total of 162 participants (162 eyes) were enrolled in this study, including 41 normal and 121 dry eye subjects. This method exhibited a sensitivity of 74.17 % and specificity of 77.5 % for dry eye diagnosis, with an AUC value of 0.8275, and cutoff value of 150.67 ng/mL, using normal subjects as negative control. The tear MMP-9 concentrations monitored with this method correlated well with the therapeutic response in dry eye patients.

Conclusions

This study developed Eu-TRFICO Schirmer strips with high sensitivity, specificity, precision, and satisfactory clinical testing performance, which provides a convenient and quantitative option for clinical testing of tear MMP-9 in dry eye patients.

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一种新的基于Schirmer条带的泪液基质金属蛋白酶测定方法在干眼症评价中的应用。

干眼病是一种眼表多因素疾病，全球患病率不断上升，但对于其诊断或严重程度评估尚无普遍接受的“金标准”。泪液基质金属蛋白酶9 （Tear matrix metalloproteinase 9, MMP-9）被广泛认为是干眼症的一种有价值的生物标志物，但目前迫切需要一种简单、准确、广泛适用的定量方法。本研究旨在建立一种基于Schirmer试纸条的eu -时间分辨荧光免疫层析（Eu-TRFICO）方法，用于泪液中MMP-9的定量检测。采用MMP-9标准对该方法进行了优化和灵敏度、重复性和均匀性评价，并对正常受试者和干眼症患者的诊断性能进行了评估。该方法的灵敏度为0.25 ng/mL，在不同的席尔默条带饱和度水平下具有良好的重复性。在162名参与者（121名干眼症患者和41名正常受试者）的队列中，根据《中国干眼症专家共识：检查与诊断（2020）》，该测试对干眼症诊断的敏感性为74.17%，特异性为77.5%。曲线下面积（AUC）为0.8275，截止值为150.67 ng/mL。此外，使用这种方法测量的泪液MMP-9水平与干眼症患者的治疗反应密切相关。该方法为泪液中MMP-9的定量提供了一种精确实用的方法，增强了其在干眼病诊断和监测中的潜在效用。目的：临床上对干眼症的诊断和评价需要简便、精确、一致的工具。基质金属蛋白酶9 （MMP-9）已被证明是干眼炎症的可靠指标。本研究的目的是建立一种eu -时间分辨荧光免疫层析（Eu-TRFICO）定量检测人泪液中MMP-9的方法。方法：对基于Schirmer试纸的泪液MMP-9检测的Eu-TRFICO方法进行优化和组装。使用MMP-9标准稀释度评价灵敏度、重复性和均匀性。对干眼症患者和正常人进行诊断和治疗监测。结果：标准曲线方程为y = 0.0037+8.0692 / [1+ (x/188.322)-0.8972] (R2 = 0.99998)，灵敏度为0.25 ng/mL。基于Schirmer试纸条的MMP-9测量结果显示，在不同的饱和长度下，在低、高标准溶液中均具有可接受的重复性和均匀性。共有162名参与者（162只眼睛）参加了这项研究，其中41名正常受试者和121名干眼症受试者。以正常受试者为阴性对照，该方法诊断干眼症的灵敏度为74.17%，特异性为77.5%，AUC值为0.8275，临界值为150.67 ng/mL。用这种方法监测的泪液MMP-9浓度与干眼症患者的治疗反应有良好的相关性。结论：本研究开发的Eu-TRFICO Schirmer试纸条灵敏度、特异性、精密度高，临床检测性能满意，为干眼症患者泪液中MMP-9的临床检测提供了方便、定量的选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ocular Surface 医学-眼科学

CiteScore

11.60

自引率

14.10%

发文量

审稿时长

39 days

期刊介绍： The Ocular Surface, a quarterly, a peer-reviewed journal, is an authoritative resource that integrates and interprets major findings in diverse fields related to the ocular surface, including ophthalmology, optometry, genetics, molecular biology, pharmacology, immunology, infectious disease, and epidemiology. Its critical review articles cover the most current knowledge on medical and surgical management of ocular surface pathology, new understandings of ocular surface physiology, the meaning of recent discoveries on how the ocular surface responds to injury and disease, and updates on drug and device development. The journal also publishes select original research reports and articles describing cutting-edge techniques and technology in the field. Benefits to authors We also provide many author benefits, such as free PDFs, a liberal copyright policy, special discounts on Elsevier publications and much more. Please click here for more information on our author services. Please see our Guide for Authors for information on article submission. If you require any further information or help, please visit our Support Center