乳胶凝集法检测唾液酸化糖链抗原KL-6的性能观察及其对间质性肺病的诊断价值

Efficiency of latex agglutination method in detecting Krebs von den Lungen-6 and its diagnostic value in patients with interstitial lung disease

目的:探讨乳胶凝集法检测唾液酸化糖链抗原KL-6的性能,并评估KL-6对间质性肺病的诊断价值。方法:检测44例表面健康人血清KL-6水平,验证试剂盒厂商提供的参考区间。比较间质性肺病(interstitial lung disease,ILD)组、其他肺病组和表面健康人组血清KL-6水平,通过绘制ROC曲线评价KL-6对ILD的诊断性能。结果:44例表面健康人血清KL-6水平有43例在厂商提供的参考范围内(>90%),通过验证。ILD组、其他肺病组和表面健康人组KL-6中位浓度分别为824(187.9~8 214)、246(101~2 129)、168(98~416)U/mL,差异有统计学意义(P<0.001)。以500U/mL为临界值,KL-6诊断ILD灵敏度和特异度分别为75%、89.8%。KL-6诊断ILD的ROC曲线下面积(AUC)为0.852(95%CI 0.793~0.911,P<0.000 1)。结论:乳胶凝集法检测血清KL-6的性能符合要求;KL-6对ILD具有较好的诊断效能,是潜在的诊断指标。

Objective:To explore the detect in efficiency of Krebs von den Lungen6(KL6)by latex agglutination method and evaluate its diagnostic value in patients with interstitial lung disease.Methods:The serum KL6levels of44healthy subjects were detected,and the reference interval provided by the kit manufacturer was verified.Serum KL6levels were compared between the ILD group,the other lung diseases group and the healthy subjects group.The diagnostic value of KL6for interstitial lung disease(ILD)was evaluated by drawing the ROC curve.Results:The serum KL6level of43in44healthy people(>90%)was within the reference range provided by the manufacturer.The median concentrations of KL6in the ILD group,the other lung diseases group and the healthy subjects group were824(187.98214),246(1012129),and168(98416)U/mL,respectively,and the differences were statistically significant(P<0.001).The sensitivity and specificity of KL6in diagnosis of ILD was75%and89.8%,respectively,with500U/mL as the cutoff value.The area under the ROC curve(AUC)of KL6for ILD diagnosis was0.852(95%CI0.7930.911,P<0.0001).Conclusions:The latex agglutination method for detecting serum KL6has good performance and KL6is a potential diagnostic index of ILD.