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Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1
in Japan
Hisao Yugi
Japanese Red Cross Central Blood Center
Study Group of the Ministry of Health, Labour and Welfare, Japan
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Objectives
For standardizations and specifications of the NAT and serological test
For evaluation of reagents
To achieve the safety of blood products
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Contents
Virus : HBV, HCV, HIV-1
Fresh frozen plasma fromvoluntary donated bloods
Source :
Panels : 100 panels each including negatives undiluted fresh frozen plasmafrom each donors
Test Items : NAT and serological tests
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Test Items
HBV DNA TaqMan PCR(J), AMPLICOR HBV Monitor(R)
Genotype DNA sequencing
Subtype deduced from sequence
IgM anti-HBc Lumipulse(F)
anti-HBs AUSAB(A), Lumipulse(F)
anti-HBc AxSYM(A), Lumipulse(F), HBcAb ELISA(O)
DNA sequencingPre-C mutation
HBsAg PRISM(A), AxSYM(A), ARCHITECT(A),Lumipulse(F), Vitros(O), HBsAg ELISA(O)
Methods/Reagents
(A):Abbott, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche
HBV Panels
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ABCDF
11255511
HBV genotype Number
early stage: 51late/carrier stage: 42
HBV PanelsHBV DNA HBsAg anti-HBcNumberCategoryPositivePositivePositivePositiveNegative
NegativeNegativePositivePositiveNegative
NegativePositiveNegativePositiveNegative
195
32377
IIIIIIIVV
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HBV Panels
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HBV Panels
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Test Items
HCV RNA TaqMan PCR(J), AMPLICOR HCV Monitor(R)
Genotype PCR
anti-HCV PHA(A), PA(F), Lumipulse(F), AxSYM(A), HCV Ab ELISA(O)
Methods/Reagents
(A):Abbott, (C):Chiron, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche
HCV Panel
HCV core Ag Lumipulse(F), HCV Ag ELISA(O), HCV Ag IRMA(O)
Lumipulse(F)anti-HCV core
RIBA(C)WB
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Preliminary Application Study
A nation-wide survey for HCV NAT
Coded panel for the survey- Genotype 1b, 2a, 2b (200-300 IU/mL)
- Negative plasma
Participants: - COBAS AMPLICOR : 92 HPs and Labs
- AMPLICOR (MWP) : 32 HPs and Labs
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ResultFalse negative result
- 1b : 2.4% (3/124)
- 2a : 6.5% (8/124)
- 2b : 2.4% (3/124)
- Neg : 0.0% (0/124)
11 sites gave false negative results9 with COBAS, 2 with MWP
Improvement ==>> No false negative nor positive result in 11 sites in the follow-up survey
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Hisao YugiShigeru TamatsukuriNorio YahagiTohru YamadaHidetaka MinakawaRetsuji YamanakaShunji IidaHarumichi MatsukuraMasaaki MizuiMitsunobu ImaiTeruhide YamaguchiHiroshi YoshizawaChief
JRC Central B.C.Roche Diagnostics K.K.Ortho-Clinical Diagnostics K.K.Abbott Japan Co. Ltd.FUJIREBIO Inc.JRC HeadquarterJRC HeadquarterJRC Osaka B.C.JRC Hiroshima B.C.Kanagawa Pref. Public Health Lab.National Inst. Health Sci.Hiroshima Univ. Graduate School Biomed. Sci.
Study group on the establishment of standardizations, specifications and test methods for the safety and quality of blood products under the Ministry of Health, Labour and Welfare, Japan