3种国产丙型肝炎病毒核酸定量与罗氏试剂检测性能的初步评价

目的评价3种国产丙型肝炎病毒核酸（HCV RNA）定量试剂检测性能。方法应用已批准上市占国内市场50%以上的3种国产HCV RNA定量检测试剂,瑞士Roche公司COBAS AmpliPrep/COBAS TaqMan HCV Test定量试剂,分别检测经Ortho和DiaSorin公司抗-HCV EIA试剂,CHIRON公司RIBA HCV 3.0SIA及MP Biomedicals Asia Pacific Pte公司确证试剂检测判定的139份抗-HCV阳性及165份抗-HCV阴性血浆样本。采用SPSS 16.0统计学软件,用χ2检验对4种HCV RNA定量试剂阳性检出率进行分析。结果 304份临床样本检测中,3种（A、B、C）国产HCV RNA定量试剂的阳性检出率显著低于瑞士Roche公司的HCV RNA定量试剂阳性检出率（11.51%、12.83%、14.80%vs 26.97%,χ2值分别为23.38、19.08、13.63,P〈0.01）,国产A、B、C试剂的阳性检出率较为一致（χ2值为1.47,P〉0.05）。国产HCV RNA定量试剂漏检样本的HCV RNA载量小于50IU/ml。以罗氏试剂检测HCV RNA水平为依据,国产试剂检测抗-HCV阴性样本的检出与HCV RNA水平不相关（即高值和低值均有检出）。结论应提高国产HCV RNA定量试剂的灵敏度和线性检测范围。

Preliminary evaluation of three domestic quantitative PCR reagents for the detection of hepatitis C virus RNA in China

Objective To evaluate the performance of three domestic quantitative PCR （qPCR） reagents for the detec- tion of hepatitis C virus （HCV） RNA. Methods HCV RNA qPCR reagents from three different manufacturers （A, B and C） that account for over 50 % of the domestic market in China, and COBAS AmpliPrep/COBAS TaqMan HCV Test quantitative reagent （Roche） were used to measure 139 anti-HCV positive and 165 anti-HCV negative plasma samples which were confirmed by HCV EIA Kits （Ortho and DiaSorin）, RIBI HCV 3.0 SIA reagents and MP Biomedicals Asia Pacific PteLtd Kits （CHIRON） . Detection rates were analyzed using SPSS 16.0 soft- ware. Results The positive detection rates of all three domestic HCV RNA qPCR reagents were significantly lower than that of Roche reagent （11.51%, 12.83%, 14.80% vs 26.97%, P〈0.01） .There were no significant difference among these three domestic reagents in the positive detection rates. Comparing to Roche reagent, there is no correlation between HCV RNA levels and the detection rates when anti-HCV negative samples were tested by using domestic reagents. Conclusions The sensitivity and linear detection range of domestic HCV RNA qPCR rea- gents should be improved.