핵산증폭검사를 위한 HBV, HCV, HIV-1 체외진단용 의료기기 국가표준품의 장기 안정성Long-Term Stability of HBV, HCV, and HIV-1 National Reference Standards for in vitro Diagnostic Medical Devices Intended to Be Used for the Nucleic Acid Amplification Test
- Authors
- 최경영; 김재현; 윤경원; 차영주; 민혁기
- Issue Date
- 2018
- Publisher
- 대한수혈학회
- Keywords
- National reference standard; Real-time stability; HBV; HCV; HIV-1
- Citation
- 대한수혈학회지, v.29, no.2, pp 171 - 181
- Pages
- 11
- Journal Title
- 대한수혈학회지
- Volume
- 29
- Number
- 2
- Start Page
- 171
- End Page
- 181
- URI
- https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/2471
- DOI
- 10.17945/kjbt.2018.29.2.171
- ISSN
- 1226-9336
- Abstract
- Background: National reference standards are essential to the quality assessment and regulatory approval of in vitro diagnostic medical devices. However, the long-term stability of national reference standards has not been comprehensively secured. This study was performed to assessment on the long-term stability of the hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus-1 (HIV-1) national reference standards intended to be used for the nucleic acid amplification test (NAT).
Methods: The viral loads of the MFDS (Korea Ministry of Food and Drug Safety) working standard and recombinant DNA for HBV, HCV, and HIV-1 were measured before and after storage at -70°C for up to 72 months using Cobas Ampliprep/Cobas Taqman assays (Roche Molecular System, Inc., Branchburg, USA) at defined time points.
Results: The viral loads of national reference standards for in vitro diagnostic medical devices of HBV, HCV, and HIV-1 stored at -70°C for up to 72 months did not differ significantly from the baseline viral load. The changes in viral load of national reference standards of HBV, HCV, and HIV-1 tested after storage at -70°C for up to 72 months ranged from -0.36 to 0.16 log10 IU/mL and did not exceed 0.5 log10, which is the estimated intra-assay variation of molecular tests.
Conclusion: The HBV, HCV, and HIV-1 national reference standards for in vitro diagnostic medical devices intended to be used for the NAT were relatively stable after long-term storage at -70°C for up to 72 months, regardless of the initial titer.
Background: National reference standards are essential to the quality assessment and regulatory approval of in vitro diagnostic medical devices. However, the long-term stability of national reference standards has not been comprehensively secured. This study was performed to assessment on the long-term stability of the hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus-1 (HIV-1) national reference standards intended to be used for the nucleic acid amplification test (NAT).
Methods: The viral loads of the MFDS (Korea Ministry of Food and Drug Safety) working standard and recombinant DNA for HBV, HCV, and HIV-1 were measured before and after storage at -70°C for up to 72 months using Cobas Ampliprep/Cobas Taqman assays (Roche Molecular System, Inc., Branchburg, USA) at defined time points.
Results: The viral loads of national reference standards for in vitro diagnostic medical devices of HBV, HCV, and HIV-1 stored at -70°C for up to 72 months did not differ significantly from the baseline viral load. The changes in viral load of national reference standards of HBV, HCV, and HIV-1 tested after storage at -70°C for up to 72 months ranged from -0.36 to 0.16 log10 IU/mL and did not exceed 0.5 log10, which is the estimated intra-assay variation of molecular tests.
Conclusion: The HBV, HCV, and HIV-1 national reference standards for in vitro diagnostic medical devices intended to be used for the NAT were relatively stable after long-term storage at -70°C for up to 72 months, regardless of the initial titer.
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - College of Medicine > College of Medicine > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/2471)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.