抗-HCV联合TMA定性检测HCV-RNA在维持性血液透析患者丙型肝炎病毒感染早期诊断中意义的探讨

Research of the significance of anti-HCV combined with HCV-RNA qualitative detection by TMA in early diagnosis of HCV infection in maintenance hemodialysis patients

目的研究维持性血液透析患者丙型肝炎病毒(HCV)感染的血清学诊断方法,探讨抗-HCV联合HCV-RNA检测在维持性血液透析患者HCV感染早期诊断中的意义,以期获得维持性血液透析患者HCV感染早期诊断的可靠方法。方法选择深圳市第二人民医院血液透析中心183例维持性血液透析患者为研究对象,分别使用国产和进口HCV抗体试剂盒检测抗-HCV,使用TMA法定性检测HCV-RNA,荧光定量PCR法定量检测HCV-RNA,比较不同产品及诊断方法对HCV的检出率,评价ALT变化与HCV-RNA载量的关系,评价抗-HCVS/CO值与HCV-RNA载量的关系。结果国产和进口试剂检测抗-HCV的检出率均为7.1%(P=1.000);TMA法定性检测HCV-RNA的检出率为8.7%,免疫荧光定量PCR法的检出率为5.5%,但两者之间差异有统计学意义(χ2=87.537,P=0.000);HCV-RNA定性检测比检测抗-HCV的检出率高,两者的差异有统计学意义(χ2=81.531,P=0.000);联合抗-HCV和HCV-RNA定性检测结果HCV阳性共19例,检出率为10.4%,与单独检测抗-HCV比较差异有统计学意义(P=0.031),但与单独定性检测HCV-RNA比较差异无统计学意义(P=0.250)。HCV-RNA的载量和ALT的变化无相关性(r=0.189,P=0.536);抗-HCV初筛的S/CO值与HCV-RNA载量无相关性(r=0.174,P=0.569)。结论 HCV-RNA定性检测较抗-HCV检测能缩短维持性血液透析患者HCV感染检出的窗口期,有利于早期诊断。HCV-RNA定性检测能较临床现行的HCV-RNA免疫荧光定量检测显著提高HCV感染的检出率。联合抗-HCV和TMA法定性检测HCV-RNA既能缩短HCV感染的"窗口期",也能显著提高HCV感染的检出率,可避免漏检处于血清转换期或慢性病毒携带或既往感染的"隐性"患者,值得临床推广应用。ALT的变化和HCV载量无明显相关性,在血液透析患者中辅助早期诊断HCV感染的作用较小。

Objective By comparing the serological diagnosis methods of HCV infection, to discussing the significance of anti-HCV combined with HCV-RNA qualitative detection by TMA in early diagnosis of HCV infection in maintenance hemodialysis patients, exploring the reliable method to diagnosis HCV infection in maintenance hemodialysis patients. Methods 183 maintenance hemodialysis patients were choosed as the research object, using domestic and imported HCV 3.0 ELISA test system to detect HCV antibody respectively;HCV-RNA was detected by using TMA and fluorescence quantitative PCR method respectively; compare their positive rates of various diagnosis methods for detection of HCV, evaluation the relationship of ALT and HCV viral load, in addition, to evaluate the relationship of anti-HCV S/CO value and HCV viral load. Results The positive rate of anti-HCV both using domestic and imported diagnostic kits was 7. 1%, there was no statistically significant difference between both of them （P = 1. 000）. The positive rate of HCV-RNA was 8.7% by TMA,while 5.5% by fluorescence quantitative PCR, there was statistically significant difference between both of them（ X2 = 87. 537 ,P = 0. 000）. The rate of HCV-RNA qualitative detection was higher than anti-HCV detection, there was statistically significant （~2 = 81. 531, P = O. 000）. The positive rate was 10.4% by an-HCV and/or HCV-RNA qualitatively,compared with the detection of anti-HCV alone （P = 0. 031 ）, there was statistically significant difference, but with the qualitative detection of HCV- RNA alone, there was no statistically significant difference （P = O. 250）. No correlation was found between the change of ALT and HCV viral load（r =0. 189,P =0. 536）. Similarly,S/CO ratio of anti-HCV had nothing to do with HCV viral load（ r = O. 174, P = O. 569 ）. Conclusions Compared with detection of anti-HCV, qualitative detection of HCV-RNA can shorten the window period after HCV infection, it would be diagnosis earlier with this method in the hemodialysis patients. Qualitative detection of HCV-RNA can increase the detection rate of HCV infection than immune fluorescence quantitative detection. Combined detection of anti-HCV and HCV-RNA qualitively can not only shorten the window period, also significantly improve the detection rate. It can avoid missing detection such ＂hidden＂ patients,who was in serum transition or chronic virus carrying or previous infection, it＇s worthy of clinical popularization and application. No obvious relevance between the change of ALT and HCV viral load, so ALT affected littlely in assisting diagnosis of HCV infection.