两种荧光定量法检测HCV RNA结果的比较

Comparison of HCV RNA detection results with two fluorescence quantitative methods

目的建立双探针荧光定量HCV RNA检测方法,分析其定量检测HCV RNA的灵敏度和特异性以及HCV RNA含量与患者病情的相关性。方法选取100例抗HCV抗体阳性患者,包括慢性肝炎患者45例、肝硬化患者30例、肝癌患者25例的样本,用双探针荧光定量法和两种商品荧光定量试剂方法进行HCV RNA检测,另观察近期196例抗HCV抗体阳性和48例抗HCV抗体阴性样本荧光定量PCR HCV RNA含量与肝功能的相关关系。结果荧光定量双探针法阳性率为93%(93/100);两种商品荧光定量试剂方法阳性率分别为84%(84/100)和79%(79/100),经卡方检验差异有统计学意义(P<0.05)。196例中抗HCV与HCV RNA阳性一致率为57.1%(116/196),其中伴肝功能改变49.0%(96/196)。HCV RNA含量与AST和ALT异常程度无显著相关性(P>0.05),相关系数分别为0.4293及0.3899。HCV RNA高拷贝数患者肝功能异常率为85.2%(69/81),低拷贝数者肝功能异常率为40.9%(47/115),经卡方检验,χ2=38.63,差异有统计学意义(P<0.001)。结论双探针荧光定量提高了HCV RNA检测的灵敏度和特异性,HCV RNA含量与患者肝功能损伤程度无明显相关性。

Objective To establish the method of double-probe real-time fluorescence quantitative reverse transcription polymerase chain reaction （RFQ-RT PCR） for detecting HCV RNA, analyze its sensitivity and specificity, and to explore the correlation between the HCV RNA content and severity of hepatitis C. Methods A total of 100 anti-HCV positive cases （including 45 cases of chronic hepatitis, 30 cases of liver cirrhosis, 25 cases of liver cancer） were quantified with RFQ-RT PCR by using double probes and detected by two other HCV RNA quantification kits simultaneously. At the same time, the correlation between HCV RNA content and liver function of 196 anti-HCV positive cases and 48 anti HCV negative cases were analyzed. Results HCV RNA positive rate was 93% （93/100） by using double-probe RFQ-RT-PCR, 84% （84/100） and 79% （79/100） with other two kits. The chi-square test displayed significant difference （P〈0.05）,, The HCV RNA positive rate of 196 anti-- HCV positive cases was 57. 1% （116/196）, which percentage in liver function abnormality was 49.0% （96/196）. The HCV RNA content and the abnormal degree of AST and ALT weren＇t significantly correlative with correlation coefficient of 0. 429 3 and 0. 389 9 respectively （P〉0. 05）. The abnormal liver function rate was 85.2% （69/81） in patients with high copy number of HCV RNA, and 40.9% （47/115） in patients with low copy number of HCV RNA （X^2 =38.63,P〈0. 001）. Conclusion Double probe real time fluorescence quantitative reverse transcription polymerase chain reaction （RFQ-RT PCR） assay increases the sensitivity and specificity of HCV RNA detection. The HCV RNA content and liver function in these hepatitis C patients isn＇t significantly correlative.