摘要
目的探讨北京泰格瑞分子检验改良SYBR GreenⅠqPCR试剂盒检测HBV DNA的临床价值。方法选用北京泰格瑞改良SYBR GreenⅠqPCR试剂盒和已获得临床应用资格的TaqMan探针法试剂盒(甲公司)对143例乙肝阴性和106例阳性血清样本检测HBV DNA含量,分别计算其灵敏度、特异性和符合率;对阳性率检测结果进行一致性分析;比较两种试剂盒标准品的扩增曲线。结果相比ELISA结果,改良SYBR GreenⅠqPCR的灵敏度、特异性和符合率分别为99.28%、95.45%、97.59%;而TaqMan探针法的灵敏度、特异性和符合率分别为98.53%、92.04%、95.58%。两种试剂盒检测的阳性率结果差异无统计学意义(P>0.05)。改良SYBR GreenⅠqPCR检测灵敏度更高(P<0.05)。改良SYBR GreenⅠqPCR标准曲线线性范围更宽,对低浓度样本检测更准确。结论泰格瑞改良SYBR GreenⅠqPCR试剂盒和甲公司TaqMan探针法试剂盒检测HBV的结果无显著差异,两试剂盒都适用于临床检测,且泰格瑞改良SYBR GreenⅠqPCR试剂盒更适于普及应用。
Objective To investigate the clinical value of detection of HBV DNA by Beijing Tagarray molecular test improved SYBR Green ⅠqPCR kit. Method Compare Beijing Tag array improved SYBR Green ⅠqPCR kit with TaqMan probe method(Jia company) in the quantification of 143 negative and 106 HBV positive serum samples, calculated the sensitivity, specificity and coincidence rate with the result of ELISA. The positive rates of detection results are consistency analysis; Comparing two kits standard amplification PCR curve. Results Compared with the ELISA results, improved SYBR Green qPCR sensitivity, specificity, and coincidence rateⅠ s are 99.28%, 95.45% and 99.28% respectively, however, TaqMan probe method, the sensitivity, specificity, and coincidence rates are 98.53%, 92.04% and 95.58%.The sensitivity of the improved SYBR Green ⅠqPCR kit is higher than that of TaqMan probe method. Difference of two positive results is not significant(P > 0.05). Improved SYBR Green qPCR detection sensitivity was higher(Ⅰ P =0.021). Improved SYBR Green ⅠqPCR wider linear range and standard curve of low concentration samples more accurately. Conclusion Improved SYBR Green ⅠqPCR kit and TaqMan probe detection kits of HBV(Jia company)results no significant difference, both kits are suitable for clinical testing, and Tag array's improved SYBR Green qPCR kit is more suitable for Ⅰ popularization application.
出处
《临床检验杂志(电子版)》
2013年第3期428-432,共5页
Clinical Laboratory Journal(Electronic Edition)