磁微粒化学发光法检测KL-6的性能评价及其临床应用价值

Performance evaluation and clinical application value of magnetic particle chemiluminescence method for detecting KL-6

目的评估化学发光定量检测KL-6试剂盒性能并评价临床应用价值。方法收集180例间质性肺疾病(ILDs)患者及135例健康者血清。参考CLSI EP相关文件,评估试剂盒的灵敏度、精密度、准确度、线性范围、干扰分析、方法学比对及临床灵敏度、特异度。采用该试剂盒监测15例治疗前、后患者血清中涎液化糖链抗原-6(KL-6)浓度,分析其临床应用价值。结果该试剂盒的空白限、检测限及分析灵敏度,分别为:8.5、21.35、24.5 U/mL;批内和批间精密度符合要求;线性范围为50.00~5000.00 U/mL;回收率在94.6%~104.0%之间,符合要求;血红蛋白、三酰甘油、胆红素浓度分别低于400、2000、45 mg/dL时,不影响检测;与富士瑞必欧化学发光试剂盒检测结果的相关系数r=0.993;试剂盒灵敏度为90.5%,特异度为94.1%;并且,患者治疗前后KL-6检测结果与患者病程进展一致。结论所验证KL-6化学发光定量检测试剂盒具有良好分析性能,且能评估ILD患者的治疗效果,适用于临床应用及推广。

Objective To evaluate the performance and clinical application value of Krebs Von den Lungen-6(KL-6)kit of chemiluminescence quantitative detection.Methods A total of 180 patients with ILDs and 135 healthy subjects were collected.According to CLSI EP documents,the sensitivity,precision,accuracy,linear range,interference analysis,methodological comparison,clinical sensitivity,and specificity of the kit were evaluated.The kit was used to monitor the serum KL-6 concentration of 15 patients before and after treatment,and to analyze its clinical application value.Results The LoB,LoD and FS of the kit were:8.5 U/mL,21.35 U/mL and 24.5 U/mL;intra-and inter-assay precision met the requirements;the linear range was 50.00-5000.00 U/mL;the recovery rate was between 94.6%-104.0%,which met the requirements;when the concentration of hemoglobin,triacylglycerol,and bilirubin were lower than 400 mg/dL,2000 mg/dL,45 mg/dL,respectively,the detection will not be affected;and the correlation coefficient r between Fujirebio chemiluminescence kit and Xieguang kit was 0.993;the sensitivity of the kit was 90.5%and the specificity was 94.1%;and the results of the KL-6 testing before and after treatment were consistent with the progression of the patient′s disease.Conclusion The KL-6 chemiluminescence quantitative detection kit have good analytical performance and can evaluate the therapeutic effect of patients with ILD.It can evaluate the therapeutic effect of ILD patients and is suitable for clinical application and promotion.