Abstract

We evaluated the reliability and validity of the 5-scale grading system to interpret the point-of-care immunoassay for tear matrix metalloproteinase (MMP)-9. Six observers graded red bands of photographs of the readout window in MMP-9 immunoassay kit (InflammaDry) two times with 2-week interval based on the 5-scale grading system (i.e. grade 0–4). Interobserver and intraobserver reliability were evaluated using intraclass correlation coefficients. The interobserver agreements were analyzed according to the severity of tear MMP-9 expression. To validate the system, a concentration calibration curve was made using MMP-9 solutions with reference concentrations, then the distribution of MMP-9 concentrations was analyzed according to the 5-scale grading system. Both intraobserver and interobserver reliability was excellent. The readout grades were significantly correlated with the quantified colorimetric densities. The interobserver variance of readout grades had no correlation with the severity of the measured densities. The band density continued to increase up to a maximal concentration (i.e. 5000 ng/mL) according to the calibration curve. The difference of grades reflected the change of MMP-9 concentrations sensitively, especially between grade 2 and 4. Together, our data indicate that the subjective 5-scale grading system in the point-of-care MMP-9 immunoassay is an easy and reliable method with acceptable accuracy.

Highlights

  • We evaluated the reliability and validity of the 5-scale grading system to interpret the point-ofcare immunoassay for tear matrix metalloproteinase (MMP)-9

  • In eyes with Dry eye disease (DED), hyperosmolar tear promotes the production of inflammatory cytokines such as interleukin (IL)-1beta and tumor necrosis factor (TNF)-alpha in human limbal epithelial cells through mitogen-activated protein kinase (MAPK) signaling ­pathway[8], which proceed to the increase in ­MMP9

  • We presented the reliability and validity of the 5-scale grading system of point-of-care matrix metalloproteinase 9 (MMP-9) immunoassay

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Summary

Introduction

We evaluated the reliability and validity of the 5-scale grading system to interpret the point-ofcare immunoassay for tear matrix metalloproteinase (MMP)-9. Tear film hyperosmolarity resulting from unstable homeostasis that fails to protect the eye from desiccating stress triggers inflammatory cascade This change induces apoptosis of cells that compose an ocular surface where a vicious cycle takes place-further instability of tear f­ilm[1]. It is a disposable and semi-quantitative test that shows the level of MMP-9 with the red-colored band within 10 min after its application to tear film in the inferior conjunctival fornix that applies lateral flow immunoassay (LFIA) This fast and convenient point-of-care device let clinicians get valuable information of ocular surface inflammation and guided them to appropriate treatment at the point of seeing the patients

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