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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

  • 摘要: 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500 U/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。

     

    Abstract: Objective:To explore the detect in efficiency of Krebs von den Lungen-6 (KL-6) by latex agglutination method and evaluate its diagnostic value in patients with interstitial lung disease. Methods:The serum KL-6 levels of 44 healthy subjects were detected, and the reference interval provided by the kit manufacturer was verified. Serum KL-6 levels were compared between the ILD group, the other lung diseases group and the healthy subjects group. The diagnostic value of KL-6 for interstitial lung disease (ILD) was evaluated by drawing the ROC curve. Results:The serum KL-6 level of 43 in 44 healthy people (>90%) was within the reference range provided by the manufacturer. The median concentrations of KL-6 in the ILD group, the other lung diseases group and the healthy subjects group were 824 (187.9-8 214), 246 (101-2 129), and 168 (98-416) U/mL, respectively, and the differences were statistically significant (P<0.001). The sensitivity and specificity of KL-6 in diagnosis of ILD was 75% and 89.8%, respectively, with 500 U/mL as the cutoff value. The area under the ROC curve (AUC) of KL-6 for ILD diagnosis was 0.852 (95% CI 0.793-0.911, P<0.0001). Conclusions:The latex agglutination method for detecting serum KL-6 has good performance and KL-6 is a potential diagnostic index of ILD.

     

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