实时荧光定量PCR检测EB病毒DNA试剂盒的性能验证及评价
| 作者: |
1孟斌,
1张好良,
1,2李世宝,
2赵耀,
1,2马萍
1 徐州医科大学附属医院检验科，江苏 徐州 221002 2 徐州医科大学医学技术学院，江苏 徐州 221002 |
| 通讯: |
马萍
Email: pingm62@aliyun.com |
| DOI: | 10.3978/j.issn.2095-6959.2018.05.004 |
摘要
目的：对新建的EB病毒(Epstein-Barr virus，EBV)DNA定量检测体系进行性能验证。方法：采用实时荧光定量PCR法检测EBV-DNA含量，并依次对精密度、准确度、人员、仪器、线性范围等性能参数进行验证及评价。结果：EBV临界质控品和强阳性质控品批内精密度分别为1.79%，0.85%，批间精密度为2.10%，1.38%，均<10%，符合行业标准。准确度绝对偏差<0.5个对数数量级。人员比对符合率为90%，仪器符合率100%。在(2.79E+02)~(4.36E+07) IU/mL范围内线性关系良好。结论：本研究新建的EBV-DNA检测体系的主要性能指标已达到相关标准的要求，可常规应用于临床。
关键词：
EB病毒DNA；精密度；准确度；线性范围；性能验证
Performance verification and evaluation of Epstein-Barr virus DNA by real-time PCR
CorrespondingAuthor: Ping MA Email: pingm62@aliyun.com
DOI: 10.3978/j.issn.2095-6959.2018.05.004
Abstract
Objective: To verify the performance of Epstein-Barr virus (EBV) DNA quantitative detection system. Methods: The DNA content of EBV was detected using real-time PCR. Then, the performance parameters of the detecting system such as precision, accuracy, personnel, equipment, linear range were validated and evaluated. Results: The intra-assay precision of EBV critical control products and strong positive control were 1.79% and 0.85% respectively. The inter-batch precision was 2.10% and 1.38%, both less than 10%, which met the industry standard. Accuracy absolute deviation is less than 0.5 logarithmic order of magnitude. The operators’ coincidence ratio were 90% and instrument was 100%. It exhibited a benign linear relation from (2.79 E +02)–(4.36 E +07) IU/mL. Conclusion: The main performance indexes of the self-built EBV-DNA detection system in this laboratory meet the requirements of relevant standards and can be carried out in clinical practice.
Keywords：
Epstein-Barr virus DNA; precision; accuracy; linear range; performance verification