DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern Experience with Roche´s COBAS AmpliPrep/COBAS TaqMan96 automated PCR system in two large.

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Presentation transcript:

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern Experience with Roche´s COBAS AmpliPrep/COBAS TaqMan96 automated PCR system in two large blood bank settings Lutz Pichl, DRK-Blutspendedienst West Christine Jork, DRK-Blutspendedienst NSTOB Lutz Pichl, DRK-Blutspendedienst West

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern DRK-BSD West DRK-BSD NSTOB Springe Hagen

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern BSD NSTOBBSD West Donations/year (2005) Samples/Day 1.15 mio ~ mio ~ Viral parameters HCV, HIV-1, HBV, HAV, PVB19 Routine testing with CAP/CTM96 since 1st Nov st July 2005 CAP/CTM96 Systems 6 x9 x

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern BSD NSTOBBSD West CAP/CTM96 combined via docking station for HBV, HCV and HIV-1 + ventilation shaft for waste air 2 CAP/CTM96 for HCV 2 CAP/CTM96 for HIV-1 1 CAP/CTM96 for HBV 1 CAP for TNAI  HAV/PVB19 RealArt LC PCR Reagents (QIAGEN Diagnostics), LightCycler 1.2 (Roche) 3 CAP/CTM96 for HCV 3 CAP/CTM96 for HIV-1 3 CAP/CTM96 for HBV 2 CAP for TNAI  HAV/PVB19 RealArt LC PCR Reagents (QIAGEN Diagnostics), LightCycler 2.0 (Roche) System configuration

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern BSD NSTOBBSD West Samples tested 668,469 (11/2005 – 05/2006) Pool size  96 Invalidity rate (HCV / HIV-1 / HBV) Failure rate 0.9 % (hardware error) < 0.2 % (clot, hardware error) NAT only positives 842,751 (07/ /2006) HCV: 2 (05) 2 (06) HBV: 1 HCV: Ø 0.27 % HIV-1: Ø 0.12 % HBV: Ø 0.05 % HIV-1: 2 (06) HBV: 1 (06) HCV: Ø 1.68 % HIV-1: Ø 0.15 % HBV: Ø 0.14 %

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern 95% detection limits BSD NSTOBBSD West HBV 675 IU WHO /ml SD251 IU WHO /ml SD HCV 582 IU WHO /ml SD624 IU WHO /ml SD HIV IU WHO /ml SD7876 IU WHO /ml SD PVB IU WHO /ml SD5735 IU WHO /ml SD HAV IU WHO /ml SD6157 IU WHO /ml SD SD = single donation in pool of 96 samples

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern Turn around time CAP/CTM Maintenance Sample Preparation 1 h NA Extraction 2 h Amplification & Detection HIV-1 3h 15‘ HCV 2h 40‘ HBV 2h 10‘ HAV/PVB 50‘ Pooling 0,5 h Result Validation Data Transfer (LIMS) 15-30‘ 6 a.m. ~1 p.m.

DRK-BSD NSTOB & West 19th SoGAT Meeting, 14/15 June 2006, Bern ProCon fully automated intensive maintenance caused by high system complexity short hands-on time additional manual result interpretation IVD conform only for single samples off label use for minipool testing; extensive validation studies virus enrichment steps unnecessary high sample volume (1050 µl brutto volume) automation of front end sample handling is users responsibility  in-house solutions Pros & Cons of CAP/CTM96 System