Performance verification of electrochemical luminescence detection reagents of HBV serological markers
10.3969/j.issn.1673-4130.2014.21.041
- VernacularTitle:电化学发光检测乙肝血清学标志物相关试剂的性能验证
- Author:
Wangxi CAI
;
Bijun TANG
- Publication Type:Journal Article
- Keywords:
electrochemical luminescence;
hepatitis B;
reagents;
quality control;
performance verification
- From:
International Journal of Laboratory Medicine
2014;(21):2955-2956
- CountryChina
- Language:Chinese
-
Abstract:
Objective To verify the performance of HBV detection reagents for Roche MODULRA E170 electrochemical lumi-nescence analyzer .Methods Referring to CLSI EP15-A document ,the minimum detection limit ,linear range ,precision and accuracy of the HBV detection reagents were verified .Results The intra-assay coefficient of variation ,total coefficient of variation ,linear range of HBsAb ,and minimum detection limits of HBsAg and HBeAg of the HBV detection reagents for MODULRA E170 electro-chemical luminescence analyzer all reached the performance claimed by manufacturer .Conclusion The performance of HBV detec-tion reagents for MODULRA E170 electrochemical luminescence analyzer is excellent ,and it can meet the needs of clinical diagnosis and treatment .
