检验医学与临床Issue(z2)：52-54,3.DOI:10.3969/j.issn.1672-9455.2014.26.022
一种新型 HBV-DNA检测方法的性能评价
Performance evaluation of a new detection method for HBV-DNA
吴敏娟 1吴建鸿 2徐俊驰 1胥萍 1马亚娜1
作者信息
- 1. 江苏省苏州市第五人民医院检验中心/感染免疫重点实验室 215007
- 2. 苏州大学医学部公共卫生学院，江苏苏州 215007
- 折叠
摘要
Abstract
Objective To evaluate the performance and clinical application of an easy operated method for HBV‐DNA .Methods 137 HBV clinical serum samples were tested quantitatively with boiling method and the new one‐step method ,and their sensitivity ,consistency and correlation of quantitative results were compared;Investigate the accuracy by detecting the EQA specimens from Ministry of Health Clinical Laboratory Center in the first half of 2014 ;Using one‐step method to test the gradient‐diluted samples ,detect its linear range and sensitivity ;Using one‐step method to .detect two cases for five times and investigate its accuracy .Results The consistency of positive de‐tection rate of the one‐step method and boiling method was 100% (93/93) ,the negative detection rate was 90 .91%(40/44)and the total conformance was 97 .08% .The four inconsistent samples′virus was positie for low concentra‐tion with the one‐step method again ,which negative for the boiling method .After reviewing the two quantitative re‐sults ,the t=0 .53(P>0 .05) ,r=0 .967 ,which shows that the detection result of one‐step method and boiling method was consistency .The quantitative results of the EQA specimens were within the scope of qualified by the one‐step method ,showing it has a scientific traceability system .;Using one‐step method to detect two cases(high concentra‐tion and low concentration)five times ,the coefficient of variation was CV=0 .049% and CV=0 .108% which shows that the precision of the one‐step method was good .Conclusion The one‐step method shows much better accuracy and sensitivity than the boiling method .With a simple procedure ,this method is suitable for clinical diagnosis .关键词
乙型肝炎病毒/荧光定量PCR/一步法/煮沸法Key words
hepatitis B virus/fluorescence quantitative polymerase chain reaction/one-step method/boiling method引用本文复制引用
吴敏娟,吴建鸿,徐俊驰,胥萍,马亚娜..一种新型 HBV-DNA检测方法的性能评价[J].检验医学与临床,2014,(z2):52-54,3.
