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Establishment of National Standards for NAT Blood Viruses and NAT Proficiency Study Program in Japan

This study discusses the establishment of national standards for NAT blood viruses and NAT proficiency study program in Japan. It includes the preparation of candidate plasma, assay details, potency calculations, and summary of assays used by the participants. The study also highlights the collaboration with various departments and working groups involved in the establishment of the national standards.

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Establishment of National Standards for NAT Blood Viruses and NAT Proficiency Study Program in Japan

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  1. Establishment of National Standardsfor NAT Blood Viruses and NAT Proficiency Study Program in Japan Saeko Mizusawa, Yoshiaki Okada National Institute of Infectious Diseases, Japan SoGAT XX In Warsaw, Poland 12-13 June 2007

  2. <Preparation of the Candidate: JRC> A candidate plasma was diluted in cryosupernatant, and stored at –80℃. <Organizer & Participants> NAT Working Group (Chaired by Dr Teruhide Yamaguchi ) Industries for Plasma Derivatives/ JRC/Proficient Labs/NIID < Assay > End-point assay 1st assay: 10-fold dilutions to determine endpoint 2nd –5th assay: 7 half-log dilutions around the endpoint <Potency of the Candidate > Calibrated against WHO International Standards Study Design for National NAT Standards

  3. Summary of Assays Used for HCV-NAT by the Participants in the Study

  4. Potency of HCV-122 Calibrated against WHO IS for HCV-RNA (96/790) Overall (a) = the overall mean potency calculated from the all laboratories Overall (b) = the overall mean potency calculated from the data excluding laboratories 1 and 2.

  5. Mean 0.01 (-0.204 - 0.201) Anti-log 1.02 (0.979 – 1.588) Potency of HCV-122 Calibrated against WHO IS for HCV-RNA (96/790)

  6. 3 Mean -0.352 (-0.539 - -0.165) Anti-log 0.444 ( 0.289 - 0.684) 2 1 IS 97/746 0 Log Rerative Potency to 3 4 2 7 1 5-2 5-1 6 -1 -2 -3 Lab. Code No. Relative Potency against WHO IS Potency for HBV-DNA (97/746) ( IU/mL) 5.65 Log -0.352 ( -0.539 - -0.165) 10 5 Anti-log 0.444 ( -0.288 - -0.683) 4.4x10 Potency of HBV-129 Calibrated against the WHO IS for HBV-DNA (97/746)

  7. Potency of HIV-00047 Calibrated against the WHO IS for HIV-DNA (97/656)

  8. National Standard International standard HCV (genotype) 1.0x105 ( 1b ) 1.0x105 ( 1 ) HBV (genotype) 4.4x105 ( C ) 1.0x106 ( A ) HIV-1 (genotype) 1.4x105 ( B ) 1.0x105 ( B ) IU/mL National Standards for NAT, Japan Each vial of a National Standard contains 0.5ml of positive plasma diluted incryosupernatant and should be stored at –80℃.

  9. NAT Proficiency Program in Japan National Standard for NAT • 1999 HCV • 2002 HBV • 2002 HIV Guideline for industry on NAT 2004 • HCV, HBV, HIV • detection limit: at least 100IU/mL NAT Control Surveillance • 2006 HBV • 2007 HCV • 2007 HIV

  10. HBV-NAT Control Surveillance 2006 Panel: 3independent assays National Standard for HBV-NAT (Genotype C) • 10000、3000、1000、300、100、30、10IU/mL& HBV Negative Plasma Laboratories of Industries :

  11. % of Positive results 36 assays =3 assays x 12 assay systems Results of HBV-NAT Control Surveillance

  12. Summary National Standard for NAT • 1999 HCV • 2002 HBV • 2002 HIV HBV-NAT for Blood Products used in Japan Fulfills Sensitivity Required in Japan NAT Guideline

  13. Collaboration with: Department of Bacteriology II, , NIID Yoshinobu Horiuchi Department of Blood and Safety Research, NIID Mizuochi Toshiaki Kazunari Yamaguchi Working Group on Establishment of the National Standards for Nucleic AcidTechnology Assay Working Group on NAT Control Surveillance

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