[Establishment of the first national standards for nucleic acid amplification technology assay for HBV DNA].
OBJECTIVE
To establish a Chinese national standard for a nucleic acid test (NAT) for HBV DNA.


METHODS
The candidate sample of HBV DNA positive plasma was diluted with HBV-negative human plasma. The sample was lyophilised with a concentration of approximately 300,000 copies/ml. The measurement methods used included Roche Amplicor assay (version 2.0) and real-time PCR. The lyophilised preparation was calibrated by the international standard (NIBSC code: 97/746) from NIBSC.


RESULTS
The quantity of this lyophilised preparation was (1.29+/-0.24) x 10(5)IU/ml in comparison with the international standard for HBV DNA 97/746. The stability test indicated that the sample was stable at room temperature (20 to 25 degrees C) for 2 weeks and at 37 degrees C for at least 1 week. Long-term stability was observed at 2 to 8 degrees C for 6 months and at -20 degrees C for more than 2 years with no significant changes. The vial-to-vial imprecision rate was 3.53%.


CONCLUSIONS
Based on the results of this study, our lyophilized sample can be used as a standard in China for the nucleic acid test (NAT) for HBV DNA.
Wang
Lu-nan
LN
National Center for Clinical Laboratory, Beijing 100730, China.
Deng
Wei
W
Shen
Zi-yu
ZY
Chen
Wen-xiang
WX
Li
Jin-ming
JM
D004279:DNA, Viral / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000592:standards*; D010949:Plasma / Q000737:chemistry
D004279:DNA, Viral