지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
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Background:Since Jan. 2012, for performance evaluation of viral reagents, analysis of domestic samples has been recommended in order to obtain approval from the KFDA when they are first introduced to Korea. This regulation requires the standard domestic materials driven from locally infected samples. We tried manufacturing the plasma working standards of HBV, HCV, and HIV NAT using a mixed titer of viral loads.
Methods:Forty three HBV DNA positive plasmas, 25 HCV RNA positive plasmas, and 26 HIV RNA positive plasmas were evaluated according to viral load and genotype. Several plasma units, which had high-titer viral loads and the common viral genotypes in Korea, were selected as the source materials for each viral standard. To adjust the appropriate concentration based on the detectable range of variable viral reagents, the source plasma was diluted to several concentrations, divided into small vials, and analyzed for quantification.
Results:The 13 plasma working standards, which had variable viral loads for the mixed titer performance panel of HIV, HCV, and HBV NAT, were produced.
Conclusion:These national standard materials were first produced in order to supply the mixed titer performance panel for the viral NAT reagent of the level IV transfusion related high-risk group in Korea.
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참고문헌 (18)
참고문헌 신청
차영주 / 2010 / 헌혈혈액 선별검사 외부신빙도조사 결과보고(2010) / 대한수혈학회지 21(3):201~209
KFDA / Guideline for Licences and Grading for Medical device
DDBJ / CLUSTALW v1.83
Kim SJ / 2008 / Comparison of two commercial real-time nucleic acid amplification methods for detecting the viral load of human immunodeficiency virus Type 1 / Korean J Blood Transfus 19:216~221
Yoo SH / 2003 / Analysis of HCV positive plasma and manufacturing of HCV RNA national standard candidate / Korean J Blood Transfus 14:35~43
KFDA / Guideline for Licences and Grading for Medical device
DDBJ / CLUSTALW v1.83
Kim SJ / 2008 / Comparison of two commercial real-time nucleic acid amplification methods for detecting the viral load of human immunodeficiency virus Type 1 / Korean J Blood Transfus 19:216~221
Yoo SH / 2003 / Analysis of HCV positive plasma and manufacturing of HCV RNA national standard candidate / Korean J Blood Transfus 14:35~43
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