Establishment of the first national standards for nucleic acid amplification technology assay for HBV DNA.
- Author:
Lu-nan WANG
1
;
Wei DENG
;
Zi-yu SHEN
;
Wen-xiang CHEN
;
Jin-ming LI
Author Information
- Publication Type:Journal Article
- MeSH: DNA, Viral; blood; Hepatitis B virus; genetics; Humans; Nucleic Acid Amplification Techniques; standards; Plasma; chemistry
- From: Chinese Journal of Hepatology 2007;15(2):107-110
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVESTo establish a Chinese national standard for a nucleic acid test (NAT) for HBV DNA.
METHODSThe 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.
RESULTSThe 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%.
CONCLUSIONBased 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.
