[A preliminary study on the tear matrix metalloproteinase 9 point-of-care assay using a domestic kit].

Objective: To compare the point-of-care assays for tear matrix metalloproteinase 9 (MMP-9) using domestic and InflammaDry kits, and to evaluate the feasibility of diagnosing dry eye with the domestic kit. Methods: It was a cross-sectional study. Thirty dry eye patients and 30 age-and sex-matched normal volunteers were continuously enrolled in this cross-sectional study from June 2022 to July 2022. Both domestic and InflammaDry kits were used to detect the tear MMP-9 levels. The positive rates were recorded for qualitative analysis, and the gray ratios of bands (the gray value of detection bands to that of control bands) were collected for quantitative analysis. The correlations of MMP-9 levels with age, ocular surface disease index, fluorescence tear break-up time, tear meniscus height, Schirmer's Ⅰ test score, corneal fluorescein staining score, and meibomian gland dropout were analyzed. The Mann-Whitney U test, paired Chi-square test, Kappa test, and Spearman's correlation coefficient were used for statistical analysis. Results: There were 14 males and 16 females (30 eyes) in the control group, and their age was (39.37±19.55) years. In the dry eye group, 11 males and 19 females (30 eyes), aged (46.87±17.85) years, had moderate to severe dry eye. The positive rates of MMP-9 in tear fluid were significantly different between dry eye patients (InflammaDry: 86.67%; domestic kit: 70.00%) and controls (InflammaDry: 16.67%, P<0.001; domestic kit: 6.67%, P<0.001). Although the sensitivity of the domestic kit was lower than that of the InflammaDry kit (70.0% vs. 86.7%, P=0.001), the specificity was higher (93.3% vs. 83.3%, P=0.001). In dry eye patients, the positive coincidence rate was 80.7% (21/26), the negative coincidence rate was 100% (4/4), and the total coincidence rate was 83.3% (25/30), with no significant difference between the two kits (McNemar test: χ2=3.20, P>0.05), and the results of both kits were consistent (Kappa=0.53, P=0.001). The Spearman's correlation coefficient showed the gray ratios using both kits were positively correlated with the corneal fluorescein staining score (InflammaDry: ρ=0.48, P<0.05; domestic kit: ρ=0.52, P=0.003). Conclusion: The performances of the domestic and InflammaDry kits are consistent in the point-of-care assay for tear MMP-9, and the domestic kit has lower sensitivity but higher specificity.目的： 对比国产泪液基质金属蛋白酶9（MMP9）试剂盒与国外已用于临床试剂盒快速检测泪液中MMP9的效果。 方法： 横断面研究。连续收集2022年6至7月在复旦大学附属眼耳鼻喉科医院干眼门诊就诊的30例（30只眼）年龄18~85岁干眼患者（干眼组）和30名（30只眼）年龄和性别均匹配的健康志愿者（健康组），采用国产MMP9试剂盒和InflammaDry试剂盒（国外已用于临床试剂盒）分别检测受检者泪液中的MMP9水平，记录2种试剂盒检测的阳性率进行定性分析，记录2种试剂盒条带灰度比值（检测条带灰度值与对照条带灰度值的比值）进行定量分析，并与患者年龄、眼表疾病指数（OSDI）评分、荧光素泪膜破裂时间（FBUT）、泪河高度、基础泪液分泌试验（SⅠt）结果、角膜荧光素染色（FL）评分及睑板腺缺失面积进行相关性分析。采用Mann-Whitney U检验、配对卡方检验、Kappa检验和Spearman相关系数等方法进行统计学分析。 结果： 健康组30名（30只眼）健康受检者，男性14名，女性16名；年龄（39.37±19.55）岁。干眼组30例（30只眼）中重度干眼患者，男性11例，女性19例；年龄（46.87±17.85）岁。检测干眼组和健康组泪液MMP9的阳性率InflammaDry试剂盒分别为86.67%（26/30）和16.67%（5/30），2个组比较的差异有统计学意义（P<0.05）；国产MMP9试剂盒分别为70.00%（21/30）和6.67%（2/30），2个组比较的差异有统计学意义（P<0.05）。国产MMP9试剂盒的检测灵敏度（70.0%）低于InflammaDry试剂盒（86.7%），特异度（93.3%）高于InflammaDry试剂盒（83.3%），2个组比较的差异均有统计学意义（均P<0.05）。2种试剂盒对干眼组进行检测，阳性符合率为80.7%（21/26），阴性符合率为100%（4/4），总符合率为83.3%（25/30），检测结果差异无统计学意义（χ2=3.20，P>0.05），2种试剂盒的检测结果一致性分析显示Kappa=0.53（P=0.001）。国产MMP9试剂盒（ρ=0.52）和InflammaDry试剂盒（ρ=0.48）的条带灰度比值均与FL评分呈正相关（P<0.05）。 结论： 国产泪液MMP9试剂盒快速检测泪液中MMP9的结果与InflammaDry试剂盒具有一致性，前者灵敏度较低但特异度更高。.