乙型肝炎病毒DNA定量试剂检测样本的结果评定与分析  

Evaluation and analysis of results of assay of hepatitis B virus DNA quantitative kit

作　　者：吴为民 李另另[2] 常青 谢平[2] 乔伟振[2] 

机构地区：[1]无锡市第八人民医院检验科,江苏无锡214011 [2]南京医科大学附属无锡市人民医院中心试验室,江苏无锡214023

出　　处：《中华医院感染学杂志》2014年第20期4985-4988,共4页Chinese Journal of Nosocomiology

基　　金：江苏省预防医学科研基金资助项目(Y201025);江苏省卫生国际交流支撑计划基金项目(苏卫国合[2011]3)

摘　　要：目的对国产乙型肝炎病毒(HBV)DNA定量试剂最低检测限样本进行结果评定与分析,评估国产定量试剂的临床应用性能。方法 2011年6月-2012年6月应用国产HBV-DNA检测试剂检测2 061份临床样本、12份灵敏度试验稀释血清、10份卫生部临床检验中心标准品中HBV-DNA含量,结合实时荧光定量曲线和DNA凝胶电泳对小于最低检测限样本进行结果评定,分别采用化学发光法和全自动生化分析仪检测低病毒载量患者血清学指标和肝功能生化指标,对FX试剂定量结果进行相关性统计分析。结果 2 061份样本中小于最低检测限的样本1 233份占59.9%,其中<1 000IU/ml的低载量阳性样本393份占19.1%;393份低病毒载量样本中有193份样本检出有至少1项肝功能生化指标异常,HBsAg、抗-HBe、抗-HBc 3项阳性的有332份占84.48%,HBsAg、HBeAg、抗-HBc阳性26份占6.62%;10份标准品经检测均能正确检出,其实测值和理论靶值相关性比较差异有统计学意义(R=0.9942,P<0.01);国产试剂检测灵敏度试验稀释血清,检出稀释度样本最低浓度为57.8IU/ml。结论国产HBV-DNA定量试剂结果为小于最低检测限的样本中存在一定比例低病毒载量HBV感染者,建议对小于最低检测限样本采用进口试剂检测确认以避免漏检。OBJECTIVE To evaluate and analyze the result of samples with HBV-DNA loads below the lowest detection limit of domestic HBV-DNA quantification kit ,so as to assess the clinical application performance . METHODS Totally 2 061 clinical serum samples ,12 serial diluted sera and 10 standards were detected by real-time quantitative PCR HBV DNA test kit from Jun 2011 .The results of less than the minimum detection limit samples were evaluated by combining real-time fluorescence quantitative curves and DNA gel electrophoresis . HBV serological markers were investigated by using chemoluminescence technique in low viral load patient sera ,and liver function markers were detected by full automatic biochemistry analyzer .The linear correlation of the HBV DNA quantitative results and the theoretical values were analyzed .RESULTS Among 2 061 clinical serum samples , 1 233 cases of HBV-DNA were below the lowest detection limit with the rate of 59 .9% ,393 （19 .1% ） of which were low load cases （HBV-DNA〈1 000 IU/ml） .Among 393 low viral load samples ,193 cases were found to have at least one abnormal liver function marker .The detection results of HBV serological markers showed that 332 cases （84 .48% ） were HBsAg/anti-HBe/anti-HBc positive and 26 （6 .62% ） cases were HBsAg/HBeAg/anti-HBc positive ,11 （2 .80% ） were HBsAg negative .The kit showed the correct results for the 10 standard specimens ,linear regression analysis showed strong correlation （R = 0 .9942 , P 〈0 .001 ） between DNA quantitative results with the theoretical values .The lowest concentration of detection of the kit was against the sensitivity diluted serum samples for HBV-DNA and was found to be 57 .8 IU/ml .CONCLUSION There were some proportion low viral load HBV infectious patients in the samles with HBV-DNA loads below the lowest detection limit of domestic HBV-DNA quantification kit .These samples should be further confirmed detection by import test kit to avoid false-negative judgments .

关 键 词：乙型肝炎病毒 核酸 试剂 病毒载量 灵敏度 

分 类 号：R512.62[医药卫生—内科学]