[Preparation and application of the national reference panel for hepatitis B virus DNA].
OBJECTIVE
To 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.


METHODS
Sera 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.


RESULTS
The 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.


CONCLUSIONS
The national reference panel for HBV DNA reagents is developed. It contains eight negative, nine positive sera and seven samples for sensitivity test
Wu
Xing
X
National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
Wang
You-chun
YC
Zhang
Hua-yuan
HY
Yang
Jun
J
Yu
Yang
Y
Lin
Jing-xiang
JX
Gu
Wen-jie
WJ
Lan
Hai-yun
HY
Li
He-min
HM
D004279:DNA, Viral / Q000592:standards*; D006515:Hepatitis B virus / Q000235:genetics*; D016133:Polymerase Chain Reaction; D012015:Reference Standards; D012680:Sensitivity and Specificity
D004279:DNA, Viral