超敏HBV DNA定量检测系统的临床应用研究

Clinical applications of highly sensitive detection system for HBV DNA quantification

目的:比较超敏HBV DNA检测系统与传统荧光定量PCR外标法定量检测血清乙肝病毒DNA,探讨其临床应用价值。方法:采用超敏PCR检测系统和传统荧光定量PCR外标法同时检测80例HBsAg阳性患者的血清HBV DNA浓度。结果:超敏法阳性检出率(92.5%)高于传统外标法(50.0%)(P<0.01)。超敏法阳性定量结果中位值为2.95×10~5IU/mL,高于传统外标法(5.63×10~4IU/mL)(P<0.01),两种方法对高载量病毒(≥10~4IU/mL)血清标本检测结果的相关性有统计学意义(R^2=0.89,P<0.01)。超敏法对26例HBeAg阴性慢性乙肝患者的阳性检出率(100.0%)高于传统外标法(11.5%)(P<0.01)。结论:超敏HBV DNA定量检测系统检测灵敏度高,更适用于临床低载量病毒(<10~4IU/mL)血清标本的检测。

Objective： To compare a highly sensitive detection system with a traditional real-time PCR assay with external standards for HBV DNA quantiifcation.Methods： hTe concentrations of serum HBV DNA in 80 HBsAg-positive patients were determined by both a highly sensitive detection system and a traditional real-time PCR assay with external standards. Results： hTe positive rate determined by the highly sensitive system （92.5%） was signiifcantly higher than that by the traditional assay （50.0%） （P〈0.01）. The median HBV DNA concentration quantified by the highly sensitive system was 2.95×10^5 IU/mL, which was signiifcantly higher than that by the traditional assay （5.63×10^4 IU/mL） （P〈0.01）. hTere was a high correlation between HBV DNA concentrations （≥10^4 IU/mL） determined by the two different assays （R2=0.89,P〈0.01）. hTe positive rate of 26 HBeAg-negative patients determined by highly sensitive system （100.0%） was signiifcantly higher than that by traditional assay （11.5%） （P〈0.01）.Conclusion： hTe highly sensitive system is more suitable for HBV DNA quantiifcation of clinical serum samples with low virus load （〈10^4 IU/mL）.