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

• Published in: The ocular surface Vol. 36; pp. 119 - 125
• Main Authors: Chen, Di, Li, Wubi, Yang, Shan, Song, Hang, Di, Yu, Zhong, Weixing, Zhang, Miao, Long, Qin, Li, Ying, Zhao, Chan
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.04.2025
• Subjects: Adult; Aged; Biomarkers - metabolism; Chromatography, Affinity - methods; Diagnostic Techniques, Ophthalmological; Dry eye; Dry Eye Syndromes - diagnosis; Dry Eye Syndromes - enzymology; Dry Eye Syndromes - metabolism; Female; Fluorescence immunochromatography; Humans; Male; Matrix Metalloproteinase 9 - analysis; Matrix Metalloproteinase 9 - metabolism; Matrix metalloproteinase-9; Middle Aged; Reagent Strips; Reproducibility of Results; ROC Curve; Schirmer strip; Sensitivity and Specificity; Tear protein; Tears - enzymology; Young Adult; Matrix metalloproteinase-9; Tear protein; Dry eye; Fluorescence immunochromatography; Schirmer strip
• ISSN: 1542-0124; 1937-5913; 1937-5913
• DOI: 10.1016/j.jtos.2025.01.004

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. 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. 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. 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. •A novel Schirmer strip-based tear MMP-9 measurement with Eu-TRFICO method was developed for dry eye evaluation.•This method demonstrated a sensitivity of 74.17% and a specificity of 77.5%, with an AUC value of 0.8275 and a cutoff value of 150.67 ng/mL in dry eye diagnosis.•Tear MMP-9 levels correlated well with therapeutic responses with this method, providing a precise and convenient approach for monitoring dry eye.