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National Standards for Blood Viruses in Taiwan

National Standards for Blood Viruses in Taiwan. Yi-Chen Yang , Yu-Hsuan Chen, Show-Lan Chiu, Hwei-Fang Cheng Drug Biology Division, Bureau of Food and Drug Analysis Department of Health, Taiwan, ROC. SoGAT XXI May 2009. Current Status of NAT Regulations.

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National Standards for Blood Viruses in Taiwan

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  1. National Standards for Blood Viruses in Taiwan Yi-Chen Yang, Yu-Hsuan Chen, Show-Lan Chiu, Hwei-Fang Cheng Drug Biology Division, Bureau of Food and Drug Analysis Department of Health, Taiwan, ROC SoGAT XXI May 2009

  2. Current Status of NAT Regulations • To improve the safety of plasma products • NAT requirements in Taiwan (2002) • The plasma pool or mini-pool should be HBV NAT (-), HCV NAT (-), and HIV NAT (-) • For S/D treated blood products, one additional VI/R step should be performed, or the plasma pool should be HAV NAT (-) • B19 NAT on plasma pool or mini-pool is suggested ~ the cut-off limit of B19 DNA should be < 105 IU/mL

  3. Regulatory Framework of Medical Device • * Special Requirements for Class III IVD • Submit sample to BFDA for licensing tests The current focus of BFDA’s work in biological standards is for IVDs that are either used in blood screening or plasma pool testing for further fractionation process.

  4. HBV DNA National Standard and Working Reagent • High titer HBV DNA (+) plasma • Screening for other blood viruses • Quantitative analysis and genotyping • Diluted with pooled human plasma* • *Screening for all major blood viruses • Calibrate the titers of candidates against the IS (97/746) by a collaborative study • 11 Labs from 7 countries • Official Medicine Control Laboratories (OMCL) & CDC (Taiwan) • Hospital laboratory & Reference laboratory • Blood Service • Manufacturers of in vitro diagnostics • Stability study • 4℃ , -20 ℃ , -80 ℃

  5. HBV DNA standard HBV DNA standard HBV DNA working reagent • Exclude the data out of the range of mean ± 2 SD

  6. HCV RNA National Standard and Working Reagent • High titer HCV RNA (+) plasma • Screening for other blood viruses • Quantitative analysis and genotyping • Diluted with pooled human cryosupernatant* • *Screening for all major blood viruses • Calibrate the titers of candidates against the IS (96/790) by a collaborative study • 8 Labs from 6 countries • Official Medicine Control Laboratories (OMCL) & CDC (Taiwan) • Hospital laboratory & Reference laboratory • Blood Service • Manufacturers of in vitro diagnostics • Stability study • 4 ℃ , -20 ℃ , -80 ℃

  7. Exclude the data out of the range of mean ± 2 SD

  8. B19 DNA National Standard and Working Reagent • High titer B19 DNA (+) plasma • Screening for other blood viruses • Quantitative analysis and genotyping • Diluted with pooled human cryosupernatant* • *Screening for all major blood viruses • Calibrate the titers of candidates against the IS (99/800) by a collaborative study • 10 Labs from 7 countries • Official Medicine Control Laboratories (OMCL) • NAT testing laboratory • Manufacturers of plasma products • Manufacturers of in vitro diagnostics • Stability study • 25℃, 4 ℃ , -20 ℃ , -80 ℃

  9. All data were within the range (mean ± 2 SD), showed that all laboratories are in good agreement with the results.

  10. National Standards and Working Reagents for NAT Assays National Standards and Reference Panels for Serological Assays • Candidate Standard for HIV-1 RNA being formulated

  11. Anti-HIV-1 Reference Panel • Anti-HIV-1 (+) plasma selection • Screening for other blood viruses • Characterized with anti-HIV diagnostic kits, HIV viral-load kit • Panel members characterization by a collaborative study • 12 Labs from 5 countries • Official Medicine Control Laboratories (OMCL) & CDC (Taiwan) • Hospital laboratory & Reference laboratory • Blood Service • Manufacturers of in vitro diagnostics • Include 22 anti-HIV diagnostic kits & Lab. in-house WB assay • Stability study • 25℃, 4 ℃ , -20 ℃ , -80 ℃ • The panel contains 6 characterized specimens • Include strong-reactive, weak-reactive, and negative samples

  12. Current Status of National Standards Used in Taiwan • Class III IVD licensing test (BFDA) • Post-market surveillance for high risk class III IVD (BFDA) • HBsAg diagnostic kits (2008) • Pick up 2 products fail to meet the sensitivity requirement • Anti-HCV diagnostic kits (2009) • kits receiving test in blood service & hospital lab. (IVD manufactures) • R&D and quality control for diagnostic kits (IVD/Biotech manufactures) • Sensitivity evaluation for purchasing diagnostic kits (Taiwan CDC) • Research (BFDA & Hospital lab.)

  13. Quantitative Data from Users (I) • Collaborative study result • Mean ± 2SD: 6 ± 0.38 Log IU/mL • Collaborative study result • Mean ± 2SD: 3 ± 0.44 Log IU/mL

  14. Quantitative Data from Users (II) • Collaborative study result • Mean ± 2SD: 4.719 ± 0.192 Log IU/mL • Collaborative study result • Mean ± 2SD: 2.949 ± 0.486 Log IU/mL

  15. Summary • We have established HBV, HCV, and B19 national standards and working reagents for NAT assays. • The standards were prepared by BFDA, and established through the international collaborative studies. • Candidate standard for HIV-1 RNA being formulated. • These NAT standards are currently used for evaluation of the molecular diagnostics market in Taiwan. • Licensing test & post-market surveillance for high risk class III IVD • Kits receiving test in blood service & hospital lab • R&D and quality control for diagnostic kits • Sensitivity evaluation for purchasing diagnostic kits

  16. Acknowledgements Thank you for your attention Thanks to all participants of the collaborative study groups Thanks to all data-feedback users

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