Analysis of HCV positive plasma and manufacturing of HCV RNA national standard candidate.
- Author:
Si Hyung YOO
1
;
Sa Rah JUNG
;
Su Jin PARK
;
Byoung Kap HWANG
;
Yoo Deok WON
;
Sang Mo KANG
;
Seung Hwa HONG
Author Information
1. Biologics Evaluation Department, Korea Food and Drug Administration, Seoul, Korea.
- Publication Type:Original Article
- Keywords:
hepatitis C virus;
national standard;
Nucleic Acid Amplification Technology
- MeSH:
Academies and Institutes;
Blood Transfusion;
DNA;
Genotype;
Hepacivirus;
Hepatitis B Surface Antigens;
HIV;
Immunoenzyme Techniques;
Korea;
Mass Screening;
Nitrogen;
Nucleic Acid Amplification Techniques;
Plasma*;
RNA*
- From:Korean Journal of Blood Transfusion
2003;14(1):35-43
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
BACKGROUNDS: Standardization of nucleic acid amplification techniques (NAT) which can be achieved by the use of standard to validate reproducibility and sensitivity in each assay run is necessary before the introduction of such methods for routine screening of blood and blood products for viral contaminants. The objective of this study was to analyze the serological and genotypic characteristics of HCV positive plasmas and to manufacture the HCV RNA national standard candidate. METHODS: We obtained three plasmas from Blood Transfusion Research Institute, Korea, with highly positive HCV RNA plasmas (#37, #40, #46) and with normal plasma for dilution. All the plasmas were confirmed by enzyme immunoassay (EIA) test for anti-HIV, HBsAg, anti-HCV and by polymerase chain reaction(PCR) for HBV DNA, HIV RNA, HCV RNA. The genotypes of those were confirmed by INNO-LiPA HCV II. HCV RNA national standard candidate was manufactured by dispensing the diluted plasma into about 2,000 vials. Each vial was rapidly frozen using liquid nitrogen and was kept in refrigerator at -70 degrees C. RESULTS: All plasmas were identified as anti-HIV, HBsAg, HBV DNA, and HIV RNA negative plasmas. The genotypes of those were confirmed as 1b for #37, 1b or 2 for #40 and 2a or 2c for #46, respectively. Sample #37 was selected as the candidate material. After manufacturing, we obtained 1,944 vials for the candidate. CONCLUSION: In this study, we analyzed HCV positive plasmas and manufactured the HCV RNA national standard candidate. In near future, this material would be established for national standard to increase in the safety of blood and blood products in Korea.
