Performance verification and evaluation of a one-step HBV DNA quantitative detecting system
10.3760/cma.j.issn.1003-9279.2017.03.017
- VernacularTitle: HBV DNA一步法定量检测性能验证及评价
- Author:
Wei YING
1
;
Wanchun LI
;
Tao SONG
;
Jue WANG
;
Fugen MO
;
Yipin WANG
;
Maoliang CHENG
Author Information
1. Center of Pathology and Laboratory Medicine, Sir Run Run Hospital, Nanjing Medical University, Nanjing 210029, China
- Publication Type:Journal Article
- Keywords:
Hepatitis B virus;
Quantitative detecting system;
Performance verification;
Fluorescence quantitative PCR
- From:
Chinese Journal of Experimental and Clinical Virology
2017;31(3):257-261
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate analytical performance and clinical application value of a one-step HBV DNA quantitative detecting system.
Methods:Analytical performance of the one-step HBV DNA quantitative detecting reagents included precision, residual contamination, accuracy, functional sensitivity and analytical measurement range were verified by collecting high concentration samples and external quality control samples from Jiangsu provincial clinical test center.
Results:The within-run coefficient of variation (CV) of both low and high concentration samples were below 5%, meanwhile the intra-assay CV was below 3/5 TEa and inter-assay CV was below 4/5 TEa. There was no residual contamination and the analytic accuracy met the requirement of external quality assessment (EQA). Functional sensitivity was able to attain 100 IU/ml, while the day to day CV was below 20%. It exhibited a benign linear relation from 7.58×101 to 7.58×108 IU/ml.
Conclusions:The analytic performance of a new testing system must be evaluated particularly before detecting samples of patients by quantitative tests. This study proves that the one-step HBV DNA quantitative detecting reagents can meet requirement of hepatitis B screening and clinical therapy monitoring, which is economic and simple for clinical routine tests.
