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Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan

Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan. Hisao Yugi. Study Group of the Ministry of Health, Labour and Welfare, Japan. Japanese Red Cross Central Blood Center. Objectives. To achieve the safety of blood products.

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Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan

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  1. Preparation of Standard Paneled Plasma for HBV, HCV, and HIV-1 in Japan Hisao Yugi Study Group of the Ministry of Health, Labour and Welfare, Japan Japanese Red Cross Central Blood Center

  2. Objectives To achieve the safety of blood products For standardizations and specifications of the NAT and serological test For evaluation of reagents

  3. Contents Virus : HBV, HCV, HIV-1 Source : Fresh frozen plasma from voluntary donated bloods Panels : 100 panels each including negatives undiluted fresh frozen plasma from each donors Test Items : NAT and serological tests

  4. HBV Panels Test Items Methods/Reagents TaqMan PCR(J), AMPLICOR HBV Monitor(R) HBV DNA HBsAg PRISM(A), AxSYM(A), ARCHITECT(A), Lumipulse(F), Vitros(O), HBsAg ELISA(O) anti-HBc AxSYM(A), Lumipulse(F), HBcAb ELISA(O) anti-HBs AUSAB(A), Lumipulse(F) IgM anti-HBc Lumipulse(F) Genotype DNA sequencing Subtype deduced from sequence Pre-C mutation DNA sequencing (A):Abbott, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche

  5. HBV Panels Category Number HBV DNA HBsAg anti-HBc I II III IV V 19 5 32 37 7 Positive Positive Positive Positive Negative Negative Negative Positive Positive Negative Negative Positive Negative Positive Negative early stage: 51 late/carrier stage: 42 HBV genotype Number A B C D F 11 25 55 1 1

  6. HBV Panels

  7. HBV Panels

  8. HCV Panel Test Items Methods/Reagents TaqMan PCR(J), AMPLICOR HCV Monitor(R) HCV RNA HCV core Ag Lumipulse(F), HCV Ag ELISA(O), HCV Ag IRMA(O) anti-HCV PHA(A), PA(F), Lumipulse(F), AxSYM(A), HCV Ab ELISA(O) anti-HCV core Lumipulse(F) WB RIBA(C) Genotype PCR (A):Abbott, (C):Chiron, (F):FUJIREBIO, (J):JRC, (O):Ortho, (R):Roche

  9. 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

  10. Result • False 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 results • 9 with COBAS, 2 with MWP Improvement ==>> No false negative nor positive result in 11 sites in the follow-up survey

  11. 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 Hisao Yugi Shigeru Tamatsukuri Norio Yahagi Tohru Yamada Hidetaka Minakawa Retsuji Yamanaka Shunji Iida Harumichi Matsukura Masaaki Mizui Mitsunobu Imai Teruhide Yamaguchi Hiroshi Yoshizawa JRC Central B.C. Roche Diagnostics K.K. Ortho-Clinical Diagnostics K.K. Abbott Japan Co. Ltd. FUJIREBIO Inc. JRC Headquarter JRC Headquarter JRC Osaka B.C. JRC Hiroshima B.C. Kanagawa Pref. Public Health Lab. National Inst. Health Sci. Hiroshima Univ. Graduate School Biomed. Sci. Chief

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