不同分析系统检测术前感染性指标的方法学比较

Comparison of different methods for detection of preoperative infectious index

目的：评价安图、 新波、 希森美康三种分析系统检测乙型肝炎病毒血清学标志物、 丙型肝炎病毒抗体（抗-HCV）、 梅毒螺旋体抗体（抗-TP）和人类免疫缺陷病毒抗体（抗-HIV）结果差异.方法：收集184例血清标本,以雅培化学发光仪为对比仪器,安图、 新波、 希森美康三种仪器为实验仪器,分别检测乙肝五项、 抗-HCV、 抗-TP、 抗-HIV,统计分析三种仪器与雅培测试结果的符合率,评估其性能差异.结果：三种分析系统对乙型肝炎病毒表面抗原（HBsAg）、 乙型肝炎病毒表面抗体（HBsAb）、 乙型肝炎病毒e抗原（HBeAg）检测结果与雅培相比对无明显差异（P〉0.05）;新波检测系统对乙型肝炎病毒e抗体（HBeAb）、 乙型肝炎病毒核心抗体（HBcAb）的检出率高于安图和希森美康（P〈0.05）;安图和新波对TP抗体检测符合率和特异性差异不大,希森美康有一定的漏检,灵敏度略低.抗-HIV三家仪器的符合率均一致.14例抗-HCV弱阳性标本经Ribba确认只有6例阳性,其余为阴性,从Ribba和雅培的综合结果来看,安图和希森美康的符合率较一致,新波的灵敏度略低.结论：安图、 新波、希森美康三种不同分析系统对八项感染性指标检测结果与进口雅培化学发光仪相比,阴性和阳性标本均有较好的一致性,但弱阳性标本符合率存在差异,基本能满足临床要求,对于弱阳性标本建议使用另一种方法复查,必要时使用确诊试验.

Objective： To investigate the performance differences of three different analyzing systems （Antu, Symbio and Sysmex） for detection of HBV serological markers, hepatitis C virus antibody（anti-HCV） , Treponema pallidum antibody （anti-TP） and human immunodeficiency virus antibody （anti-HIV）. Methods： 184 serum samples were collected for evaluation. The performance and accuracy of the Antu, Symbio and Sysmex analyzing systems for detection the five serological HBV markers, anti-HCV, anti-TP, anti-HIV were evaluated by using Abbott chemiluminescence system as reference instrument. Results： There were no significant differences among the three analyze systems for measuring serum HBsAg, HBsAb and HBeAg as compared with the Abbott analyzing system （P〉0.05）, while the detection rate of serum HBeAb and HBcAb is markedly higher by using Symbio system than that of Antu and Sysmex （P〈0.05）. In the meanwhile, there is no obvious difference of the diagnostic coincidence and specificity for anti-TP between the Antu and Symbio system, while a missed detection and slightly lower sensitivity can be observed in the Sysmex analyze system. The performance for anti-HIV detection is quite consistence among the three analyze systems. Of the 14 anti-HCV weakly positive samples, 6 samples showed positive results by Ribba test, while the other 8 samples were negative. By combining the detection results of Ribba test and the testing result of Abbott detection system, the detection coincidence rate is quite consistent between the Antu and Sysmex system, however, the Symbio system displays a slightly lower sensitivity. Conclusion： The coincidence for detecting the eight serological infection markers by Antu, Symbio and Sysmex analyzing systems were comparable with the Abbott luminous instrument and can basically meet the clinical requirements, nevertheless, the different coincidence rate for weakly positive samples is still existed, thus weakly positive samples were suggested to go through countercheck by another system, and even confirmation test when necessary.