摘要
目的评价国产HCV核酸扩增荧光定量试剂（国产试剂）和RocheCOBAS AmpliPrep ／COBAS TaqMan 48（RocheCOBAS TaqMan）试剂对慢性丙型肝炎（丙肝）患者快速病毒学应答（rapid virological response，RVR）和早期病毒学应答（early virological response，EVR）判定的效果，探讨国产试剂在慢性丙肝治疗中的应用价值。方法收集223例慢性丙肝抗病毒治疗前、治疗第4周和第12周的血清标本，分别采用RocheCOBAS TaqMan试剂和国产试剂检测血清HCVRNA载量，比较和分析2种试剂对RVR和EVR的判定。结果治疗前患者HCVRNA载量为（6．24±0．97）log10（RocheCOBAS TaqMan检测）。国产试剂判定RVR的假阴性率为37．3％（95％置信区间26．4％-48．6％），判定EVR的假阴性率为20．8％（95％置信区间4．6％～37．0％）。治疗第4周时，国产试剂未检测到28例的HCVRNA，其治疗第12周的血清标本采用RocheCOBASTaqMan检测，27例未检测到HCVRNA，1例HCVRNA为2．78log10。结论抗病毒治疗第4周和第12周时，应采用灵敏度高的试剂检测慢性丙肝患者的HCVRNA载量。如果治疗第4周时采用国产试剂未检测到HCVRNA，则可判定患者能获得EVR，可根据EVR确定疗程。
Objective To evaluate the determination of rapid virological response （RVR） and early virological response （EVR） by detecting the serum samles of paitents with chronic hepatitis C （CHC） with generic real-time quantitative PCR kits （domestic reagents） and Roche COBAS AmpliPrep/COBAS TaqMan 48 （Roche COBAS TaqMan） and investigate the application value of domestic reagents in the treatment of CHC. Methods Serum samples were collected from 223 CHC patients before treatment and at week 4 and 12 of treatment. Roche COBAS TaqMan and domestic reagents were used to detect HCV RNA. The determination of RVR and EVR with the two reagents were compared and analyzed. Results HCV RNA was （6.24±0.97） log10 （Roche COBAS Taq- Man） before treatment in 223 CHC patients. False negative rate for the determination of RVR with domestic reagents was 37.3% （95% confidence interval 26.4%-48.6%）, and that for the determination of EVR was 20.8% （95% confidence interval 4.6%-37.0%）. At week 4 of treatment, HCV RNA was not detected in 28 patients with domestic reagents. The serum samples of the 28 paitents were detected with Roche COBAS TaqMan at week 12 and it was found that HCV RNA was not detected in 27 patients and was 2.78 logl0 in one patient. Conclusions It is suggested that the reagents with high sensitivity should be used to detect HCV RNA at week 4 and 12 of treatment. If HCV RNA was not detected with domestic reagents at week 4, it can be concluded that the patients can achieve EVR and the treatment duration can be decided aecording to EVR.
出处
《传染病信息》
2012年第3期177-179,共3页
Infectious Disease Information
基金
国家"十一五"科技重大专项(2008ZX10002-013)
北京大学人民医院研究与发展基金(RDC2007-18
RDB2011-07)
