超敏HBV DNA定量检测系统的临床应用研究
| 作者: |
1,1徐婷,
1赵鸿,
1张洁心,
1王芳,
1潘世扬,
1黄珮珺,
1陈丹
1 南京医科大学第一附属医院检验学部，南京 210029 |
| 通讯: |
陈丹
Email: lab.med@163.com |
| DOI: | 10.3978/j.issn.2095-6959.2015.08.022 |
| 基金: | 国家自然科学基金, 81371894，81302531，81272324，81201359，81101322 江苏省实验诊断学重点实验室, XK201114 江苏高校优势学科建设工程基金项目 |
摘要
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2.95×105 IU/mL，高于传统外标法(5.63×104 IU/mL)(P<0.01)，两种方法对高载量病毒(≥104 IU/mL)血清标本检测结果的相关性有统计学意义(R2=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(<104 IU/mL)血清标本的检测。
关键词：
HBV DNA
定量
慢性乙型肝炎
HBeAg
Clinical applications of highly sensitive detection system for HBV DNA quantification
CorrespondingAuthor: CHEN Dan Email: lab.med@163.com
DOI: 10.3978/j.issn.2095-6959.2015.08.022
Abstract
Objective: To compare a highly sensitive detection system with a traditional real-time PCR assay with external standards for HBV DNA quantification. Methods: The 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: The positive rate determined by the highly sensitive system (92.5%) was significantly higher than that by the traditional assay (50.0%) (P<0.01). The median HBV DNA concentration quantified by the highly sensitive system was 2.95×105 IU/mL, which was significantly higher than that by the traditional assay (5.63×104 IU/mL) (P<0.01). There was a high correlation between HBV DNA concentrations (≥104 IU/mL) determined by the two different assays (R2=0.89, P<0.01). The positive rate of 26 HBeAg-negative patients determined by highly sensitive system (100.0%) was significantly higher than that by traditional assay (11.5%) (P<0.01). Conclusion: The highly sensitive system is more suitable for HBV DNA quantification of clinical serum samples with low virus load (<104 IU/mL).