Preparation and application of the national reference panel for hepatitis B virus DNA.
- Author:
Xing WU
1
;
You-chun WANG
;
Hua-yuan ZHANG
;
Jun YANG
;
Yang YU
;
Jing-xiang LIN
;
Wen-jie GU
;
Hai-yun LAN
;
He-min LI
Author Information
- Publication Type:Journal Article
- MeSH: DNA, Viral; standards; Hepatitis B virus; genetics; Polymerase Chain Reaction; Reference Standards; Sensitivity and Specificity
- From: Chinese Journal of Hepatology 2003;11(7):402-404
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVESTo calibrate the national hepatitis B virus (HBV) DNA standard according to world health organization's standard material and prepare the national reference panel for HBV DNA reagents.
METHODSSera from blood donors and HBV patients were collected and detected by home-made HBV DNA PCR kits, HBsAg kits, and anti-HBc kits, and then confirmed by HBV DNA PCR kits produced by Roche in German, which was recognized by the world health organization. The stability of the panel was detected by acceleration method.
RESULTSThe convinced copies of the sensitivity samples were gotten by seven independent experiments, the coefficients of variation of logarithm of the copies of L0-L5 were all less than 15%. Regarding the national reference panel as the standard, the quality of most domestic HBV DNA PCR kits was improved, while part of the kits should be further qualified.
CONCLUSIONThe national reference panel for HBV DNA reagents is developed. It contains eight negative, nine positive sera and seven samples for sensitivity test
