三种PIVKA-Ⅱ试剂的临床诊断效能评价

Clinical performance comparison of 3 PIVKA-Ⅱ detection reagents

目的比较三种PIVKA-Ⅱ检测试剂的临床诊断效能,为检测机构选择提供参考依据。方法收集健康对照组、慢性乙型肝炎组(慢乙肝)、肝硬化组和肝癌组四组临床血清样本,分别用三种不同试剂进行PIVKA-Ⅱ检测,对检测结果进行一致性、分布情况、诊断效能分析。结果共收集217例临床血清样本,其中健康对照组33例、慢乙肝组33例、肝硬化组86例和肝癌组65例,各组男女比例差异无统计学意义(P>0.05)。三种试剂中,Abbott和Fuji检测结果具有较好的一致性(R2=0.84,P<0.05)。Roche与Abbott、Fuji的离群值多分布于肝癌组样本,且为PIVKA-Ⅱ高值样本。在肝癌诊断中,ROC分析显示Abbott、Fuji和Roche的AUC分别为0.882、0.878、0.857,最佳临界值分别为56.67 mAU/ml、68.00 mAU/ml、26.41 ng/ml。结论三种试剂均具有良好的临床诊断效能,其中Abbott和Fuji具有较好的一致性。Roche与Abbott、Fuji的离群值多分布于肝癌高值样本。

Objective To compare the clinical diagnosis efficiency of 3 PIVKA-Ⅱdetection reagents,and provide a reference for testing institutions selection.Methods Clinical serum samples were collected from healthy control group,chronic hepatitis B(CHB)group,liver cirrhosis group and liver cancer group patients.PIVKA-Ⅱwas detected by 3 different detection reagents,and compared in consistent,distribution characteristics and diagnosis efficiency.Results A total of 217 clinical serum samples were collected,including 33 healthy controls patients,33 CHB patients,86 cirrhosis patients,and 65 liver cancer patients.There was no significant difference in gender among the groups(P>0.05).The results of Abbott and Fuji had a good consistency(R2=0.84,P<0.05).The outlier values of Roche to Abbott and Fuji were mostly distributed in the liver cancer group,as well as in the high-value PIVKA-Ⅱsamples.In ROC analysis of liver cancer diagnosis,the AUC of Abbott,Fuji and Roche were 0.882,0.878 and 0.857,respectively.The optimal cut-off values were 56.67 mAU/ml,68.00 mAU/ml and 26.41 ng/ml,respectively.Conclusion All the three reagents showed good clinical diagnostic efficacy,Abbott and Fuji showed good consistency.The outlier values of Roche,Abbott and Fuji were mostly distributed in the high-value PIVKA-Ⅱliver cancer samples.