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A multi-centre NAT evaluation study of run and trend control samples

A multi-centre NAT evaluation study of run and trend control samples Harry van Drimmelen 1 , Joe O’Donnellan 2 , Rene Bax 1 , Henrik Ullum 3 and the Danish NAT study group and Wim Quint 1 1. Biologicals Quality Control Unit, Delft Diagnostic Laboratory (DDL), the Netherlands,

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A multi-centre NAT evaluation study of run and trend control samples

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  1. A multi-centre NAT evaluation study of run and trend control samples Harry van Drimmelen1, Joe O’Donnellan2, Rene Bax1, Henrik Ullum3 and the Danish NAT study group and Wim Quint1 1. Biologicals Quality Control Unit, Delft Diagnostic Laboratory (DDL), the Netherlands, 2. Irish Blood Transfusion Service (IBTS), Dublin, Ireland 3. Rigshospitalet, Copenhagen, Denmark .

  2. Background I Recalibration of standards in copies/ml • HBV, HCV and HIV-1 analytical and infectivity standards1,2.3 have been recently recalibrated in copies/ml using multiple bDNA 3.0 assays4 • The recalibrated standards have been used for analytical sensitivity studies5,6 and TTI risk analysis7-12 1.Lelie N. et al. Transfusion 2002:42;527. 2. Komiya K et al. Transfusion 2008;48:286 3. Katayama K et al, Intervirology, 2004, 47, 57 4. Van Drimmelen A.A.J. Vox Sang 96 Suppl1 ISBT abstract P075. 5. Assal et al. Transfusion 2009; 49:289 6. Assal et al. Transfusion 2009; 49:289 301. 7.Weusten J et al, Transfusion, accepted. 8. M. El Ekiaby et al. Vox Sang 96, Suppl1, ISBT abstract; 9 . El Ekiaby et al. Vox Sang 96, Suppl1, ISBT abstract; 17. 10. Vermeulen M et al, Transfusion 2009: in press. 11. Kleinman S et al Vox Sang 96, Suppl1, ISBT abstract; 12 . Goubran et al. Novartis, ISBT Satellite meeting, Cairo, 2009 ..

  3. Background IIRecalibration of standards in copies/ml 63% LOD (cps/assay) DDL standard studies theoretical limit is 1 HIV-RNA copy per TMA assay WHO standard studies

  4. Aim of the study • Compare different HBV, HCV and HIV Quality Control standards in a multi-centre validation study of ULTRIO on TIGRIS in Denmark and Ireland • Analyze TMA response values on QC standard dilutions to establish suitable run or trend control levels

  5. Methods IInactivation viral standards (DDL) 1. Lelie PN. , Reesink HW , Niessen J. , Brotman B and Prince AM. Inactivation of 1015 chimpanzee infectious doses of hepatitis B virus during preparation of an heat-inactivated hepatitis B vaccine. J. Med. Virol. 1987:23: 289-95 2. Dichtelmüller SW, Prince AM, Brotman B, Huima T. Inactivation of the Hutchinson strain of hepatitis non-A, non-B virus in intravenous immunoglobulin by beta-propiolactone. J Med Virol. 1988: 26:227-32. 3.. Lelie PN. Reesink HW and Lucas CJ. Inactivation of 12 viruses by heating steps applied during manufacture of a hepatitis B vaccine J. Med. Virol. 1987:23: 297-301.

  6. Methods IIIQC samples evaluated • NIBSC working reagents • Seracare-BBI Accurun range • Acrometrix PeliSpy pro range • ISS standards • DDL bioQControl check and trend controls • DDL inactivated standard dilutions

  7. Methods IVCharacteristics QC samples * Defibrination; removal of cry precipitating proteins

  8. Methods V multi-centre performance evaluation study • Five laboratories from Denmark and Ireland tested multiple replicates of QC samples on TIGRIS in validation phase • Inactivated viral standard dilutions were tested in multiple replicates (n=52-58) and 95% and 50% detection limits were determined by probit analysis • QC samples were tested in 1:3 and 1:10 dilutions (n=30-33) • Distribution of ULTRIO S/CO response values on inactivated standard dilutions were analyzed • Longitudinal Procleix Duplex S/CO values of IBTS (Ireland) on HCV trend control sample (27 cps/ml) were analyzed

  9. Results I detection limits on inactivated standards

  10. Proportion of reactive ULTRIO tests (n=33) on diluted run control samples * for HBV ULTRIO 1000 and 200 cps/ml ** for HCV 5700 IU/ml diluted to 40 and 12.5 IU/ml and for HIV 4000 IU/ml diluted to 100 and 33 IU/ml

  11. Distribution S/CO results (n=52) for inactivated HCV-RNA standard dilutions saturated 35 cps/ml 116 cps/ml 345 cps/ml 35 12 cps/ml 0-1 1-2 2-3 3-4 4-5 5-6 6-7 7-8 8-9

  12. Distribution S/CO results (n=778 runs) on HCV-RNA trend control (27 cps/ml) 0-1 1-2 2-3 3-4 4-5 5-6 6-7 7-8 8-9 9-10

  13. Averaged (50) proportion TMA reactive (n=778 HCV Procleix duplex runs) % reactive (mean + 25 and – 25 runs) % saturated (mean + 25 and – 25 runs)

  14. Conclusions and discussion • Viral concentration in most QC samples appears to be sufficiently critical for external run controls • Run controls should be quantified; consistent concentrations between different batches • ULTRIO detection limits on untreated and inactivated viral standards were comparable* • A trend control sample of ~25 cps/ml (around the 90-95% detection limit) is more instrumental for longitudinal monitoring of analytical sensitivity of TMA test runs** * For HBV further studies required to prove the correct calibration in copies/ml ** Follow percentage TMA reactive and the distribution of S/CO values over time

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