Roche定量试剂和国产PCR试剂检测HBV―DNA比较分析.docVIP

Roche定量试剂和国产PCR试剂检测HBV―DNA比较分析 　　[摘要] 目的 探?Roche定量试剂和国产PCR试剂检测慢性HBV感染者血清HBV-DNA的差异。 方法 收集慢性HBV感染患者366例，包括慢性乙型肝炎患者247例，乙肝肝硬化失代偿患者72例，乙肝相关性肝癌患者28例，乙型慢加急性肝衰竭患者19例；采用Roche定量试剂（试剂A）和和国产PCR试剂（试剂B）检测患者血清HBV-DNA，比较检测结果的差异、相关性及影响因素。 结果 试剂B 124例（33.88%）低于检测下限而试剂A高于检测下限（包括24例超过1.00×103 IU/mL，考虑试剂B为假阴性）；试剂A的阳性率（70.49%）显著高于试剂B（36.61%）（P0.01）。试剂A的HBV-DNA检测均值高于试剂B（P0.05），HBeAg滴度低者、终末期患者更容易出现COBAS系统的血清HBV-DNA检测值高于国产试剂的情况。Spearman相关分析显示，两种试剂在1.00×103 IU/mLHBV-DNA1.00×107 IU/mL时的相关性较好（r=0.74，P0.01）。 结论 国产PCR试剂可以满足慢性HBV感染患者抗病毒治疗随访、监测的需求；但针对那些怀疑有低病毒复制状态或病毒变异导致HBV-DNA检测结果假阴性的患者，有必要用COBAS系统予以复核。 　　[关键词] 乙型肝炎病毒；COBAS Taqman系统；荧光定量PCR 　　[中图分类号] R446.1 [文献标识码] B [文章编号] 1673-9701（2017）34-0114-04 　　Comparative analysis of Roche quantitative reagent and domestic PCR reagent for detection of HBV-DNA 　　ZHOU Meiying1 GAO Guosheng2 HU Airong3 　　1.Center Laboratory，Zhejiang Taizhou Hospital，Taizhou 317000，China；2.Department of Clinical Laboratory，Ningbo City Second Hospital，Ningbo 315010，China；3.Department of Liver Diseases，Ningbo City Second Hospital，Ningbo 315010，China 　　[Abstract] Objective To investigate the difference in detecting serum HBV-DNA of chronic HBV infection patients between Roche quantitative reagent and domestic PCR reagent. Methods 366 patients with chronic HBV infection were collected， including 247 patients with chronic hepatitis B， 72 patients with decompensated liver cirrhosis， 28 patients with hepatitis B-related hepatocellular carcinoma and 19 patients with acute-on-chronic liver failure. Roche quantitative reagent（reagent A）and domestic PCR reagent（reagent B）were used to detect the serum HBV-DNA. And the difference of the detection results， the correlation and influencing factors between the two reagents were compared. Results There were 124 cases（33.88%） which were below the detection limit detected by reagent B and above the detection limit detected by reagent A， including 24 cases more than 1.00×103 IU/mL， considering reagent B as false negative. The positive ra