NucliSens miniMag与QIAamp系统检测血清丙型肝炎病毒RNA效能比较

Serum HCV RNA detection by NucliSens miniMag and QIAamp system

目的比较研究NucliSens miniMag与QIAamp系统检测血清丙型肝炎病毒(HCV)RNA的效能。方法2021年6月~2023年6月我院收集的103例抗-HCV阳性血清标本,分别采用NucliSens miniMag系统(方法A)和QIAamp Viral RNA Mini Kit(方法B)提取HCV RNA,采用实时荧光定量RT-PCR法检测血清HCV RNA载量。取高载量和低载量两份标本,分批重复检测,计算两种方法批内变异系数(CV)。取HCV RNA强阳性质控标本,梯度稀释后检测,评估两种方法检测的敏感度。结果在103例血清抗-HCV阳性血清标本中,经方法A和方法B提取核酸,检测血清HCV RNA阳性率分别为86.4%和82.5%,差异无统计学意义(P>0.05);方法A提取核酸检测的血清HCV RNA载量为(5.4±1.2)lg IU/mL,方法B检测结果为(5.0±1.6)lg IU/mL,差异有统计学意义(t=2.078,P=0.039);方法A提取核酸检测血清HCV RNA载量低值和高值的CV分别为2.4%和2.2%,方法B检测为4.7%和4.5%,方法A提取核酸检测HCV RNA的重复性优于方法B;方法A提取检测血清HCV RNA最低载量为2.8×10^(-6)lg IU/mL,低于方法B检测的3.5×10^(-6)lg IU/mL,表明更灵敏。结论与QIAamp Viral RNA Mini Kit相比,NucliSens miniMag系统检测血清HCV RNA的效能更高。

Objective The purpose of this study was to compare performance of NucliSens miniMag system and QIAamp Viral RNA Mini Kit in detecting serum HCV RNA loads.Methods 103 serum samples with anti-HCV positive were collected in our hospital between June 2021 and June 2023,and serum RNA was extracted by NucliSens miniMag system or QIAamp Viral RNA Mini Kit,respectively.Serum HCV RNA loads were detected by real-time fluorescence quantitative RT-PCR.Repetition and sensitivity were assessed.Results Of 103 anti-HCV positive serum samples,serum HCV RNA positive rates by NucliSens miniMag system and QIAamp system were 86.4%and 82.5%(P>0.05);serum HCV RNA load by NucliSens miniMag system was(5.4±1.2)lg IU/mL,much higher than(5.0±1.6)lg IU/mL by QIAamp kit(t=2.078,P=0.039);coefficient of variation of lowest and highest serum HCV RNA loads by NucliSens miniMag system were 2.4%and 2.2%,much superior to 4.7%and 4.5%by QIAamp kit;lowest serum HCV RNA load by NucliSens miniMag system detection was 2.8×10^(-6)lg IU/mL,much sensitive than 3.5×10^(-6)lg IU/mL by QIAamp kit.Conclusion Efficacy of serum HCV RNA assay by NucliSens miniMag system is satisfactory,which could help clinicians diagnose patients with chronic hepatitis C.