摘要
目的研制可准确判断HBV感染者拉米付定耐药状况的YMDD突变检测试剂盒。方法采用UniArray技术建立YMDD检测体系和试剂盒,对其检测的灵敏度、特异度和准确性进行分析,并与测序结果进行比较研究。结果实验设立了3个检测位点,内参照、YIDD和YVDD,并确立其反应体系和3个反应体系的相互关系,在大量临床实验基础上,以血清DNA测序结果为金标准,确立了以△Ct≤3为本法阳性判断标准。按此标准,临床检测HBV灵敏度为3.9×104copies/ml,人群检测灵敏度为96.4%,特异性为100%,准确性为97.6%,CV%为0.58%~4.16%,完全能达到测序的检测水平。结论建立了UniArray技术检测HBV拉米付定耐药方法,该方法灵敏、特异,与测序结果有非常高的符合率,且能反映比测序更多的信息。
Objective To develop detecting kit for YMDD mutations among patients infected Hepatitis B virus with Lamivudine resistance. Methods Based on the Uniarray detecting system for YMDD, the capability of the Kit, such as sensitivity, specificity, and accuracy, had been evaluated. And the capability results were compared with those of sequencing. Results Three detecting psitions and their relationships had been established. △Ct≤3 was ascertained as cut off value. According to the standard, the sensitivity of HBV detecting power was 3.9 ×10^4copies/ml, while the sensitivity of herd detecting rate was 96.4% and the specificity was 100%. The analysis precision was between 0.58% and 4.16%. Conclusions The UniArray detecting system for lamivudine resistance of Hepatitis 13 virus was very sensitive and specific, which may had more advantage than sequencing.
出处
《疾病控制杂志》
2006年第3期229-233,共5页
Chinese Journal of Disease Control and Prevention
