国产PCR试剂和COBAS系统血清HBV-DNA检测结果不一致的原因分析

Analysis of the causes of inconsistency of serum HBV-DNA test results between homemade PCR reagent and COBAS system

目的探讨国产PCR试剂和COBAS系统血清HBV-DNA检测结果不一致的原因。方法收集2013年12月~2015年10月来本院肝病中心就诊的慢性HBV感染者230例,国产PCR试剂血清HBV-DNA结果均为阴性,应用COBAS系统予以复查,分析两种方法 HBV-DNA检测结果的差异及可能的影响因素。结果 106例(46.09%)患者两种方法血清HBV-DNA检测结果均低于检测下限;124例(53.91%)患者在COBAS系统可检测到不同载量的HBV-DNA,包括3例(1.30%)隐匿性HBV感染。随着患者血清HBV-DNA载量的增加,性别比、HBe Ag效价和阳性率、血常规和凝血功能等指标差异均无统计学意义(P>0.05),但血清HBs Ag效价、终末期肝病构成比、肝功能酶类指标、AFP等逐渐升高(P<0.05)。血清HBV-DNA与HBs Ag效价、肝功能指标、AFP均有一定相关性(P<0.05),与HBe Ag效价无相关性(P=0.87)。结论针对肝功能指标异常、HBs Ag效价较高、病情较重(特别是终末期肝病)的慢性HBV感染患者,国产PCR试剂检测血清HBV-DNA阴性时有必要应用COBAS系统复查。

Objective To explore the causes of inconsistency of serum HBV-DNA test results between homemade PCR reagent and COBAS system. Methods A total of 230 patients with chronic HBV infection who were diagnosed in the Center for Liver Diseases in our hospital from December 2013 to October 2015 were collected. The serum HBV-DNA results of homemade PCR reagents were all negative. COBAS system was applied for retest. The differences of HBV- DNA test results by both methods and the possible influencing factors were analyzed. Results The test results of serum HBV-DNA in 106 cases （46.09%） were lower than the lower limit of detection in both methods, HBV-DNA with differ- ent capacity was detected in the COBAS system in 124 patients（53.91%）, including 3 cases（1.30%） of occult HBV in- fection. With the increase of patients＂ serum HBV-DNA capacity, there was no significant difference in sex ratio, HBeAg valence and positive rate, blood routine test and coagulation function（P〉0.05）. But serum HBsAg valence, end- stage liver disease ratio, liver function enzyme index, and AFP were gradually increased（P〈0.05）. Serum HBV-DNA was associated with HBsAg valence, liver function index and AFP （P〈0.05）, yet was not associated with HBeAg valence （P=0.87）. Conclusion In patients with chronic HBV infection who have abnormal liver function, high HBsAg valence, and severe illness（especially end-stage liver disease）, negative results of serum HBV-DNA tested by homemade PCR reagents need to be re-tested by COBAS system.