핵산증폭검사를 위한 HBV, HCV, HIV-1 체외진단용 의료기기 국가표준품의 장기 안정성
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 최경영 | - |
dc.contributor.author | 김재현 | - |
dc.contributor.author | 윤경원 | - |
dc.contributor.author | 차영주 | - |
dc.contributor.author | 민혁기 | - |
dc.date.available | 2019-03-08T05:37:25Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 1226-9336 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/2471 | - |
dc.description.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. | - |
dc.description.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. | - |
dc.format.extent | 11 | - |
dc.language | 한국어 | - |
dc.language.iso | KOR | - |
dc.publisher | 대한수혈학회 | - |
dc.title | 핵산증폭검사를 위한 HBV, HCV, HIV-1 체외진단용 의료기기 국가표준품의 장기 안정성 | - |
dc.title.alternative | Long-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 | - |
dc.type | Article | - |
dc.identifier.doi | 10.17945/kjbt.2018.29.2.171 | - |
dc.identifier.bibliographicCitation | 대한수혈학회지, v.29, no.2, pp 171 - 181 | - |
dc.identifier.kciid | ART002380657 | - |
dc.description.isOpenAccess | N | - |
dc.citation.endPage | 181 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 171 | - |
dc.citation.title | 대한수혈학회지 | - |
dc.citation.volume | 29 | - |
dc.publisher.location | 대한민국 | - |
dc.subject.keywordAuthor | National reference standard | - |
dc.subject.keywordAuthor | Real-time stability | - |
dc.subject.keywordAuthor | HBV | - |
dc.subject.keywordAuthor | HCV | - |
dc.subject.keywordAuthor | HIV-1 | - |
dc.description.journalRegisteredClass | kci | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
84, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea (06974)02-820-6194
COPYRIGHT 2019 Chung-Ang University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.