Experience with Roche´s COBAS Ampli. Prep/COBAS Taq. Man 96 automated PCR system in two large blood bank settings Christine Jork, DRK-Blutspendedienst West Lutz Pichl , NSTOB DRK-BSD NSTOB & West 19 th So. GAT Meeting, 14/15 June 2006, Bern
Springe DRK-BSD West DRK-BSD NSTOB & West Hagen DRK-BSD NSTOB 19 th So. GAT Meeting, 14/15 June 2006, Bern
Donations/year (2005) Samples/Day Viral parameters Routine testing with CAP/CTM 96 since CAP/CTM 96 Systems DRK-BSD NSTOB & West BSD NSTOB 1. 15 mio ~ 4. 000 BSD West 1. 26 mio ~ 4. 000 HCV, HIV-1, HBV, HAV, PVB 19 1 st Nov. 2005 1 st July 2005 6 x 9 x 19 th So. GAT Meeting, 14/15 June 2006, Bern
System configuration BSD NSTOB CAP/CTM 96 combined via docking station for HBV, HCV and HIV-1 BSD West CAP/CTM 96 combined via docking station for HBV, HCV and HIV-1 + ventilation shaft for waste air 2 CAP/CTM 96 for HCV 3 CAP/CTM 96 for HCV 2 CAP/CTM 96 for HIV-1 3 CAP/CTM 96 for HIV-1 1 CAP/CTM 96 for HBV 3 CAP/CTM 96 for HBV 1 CAP for TNAI HAV/PVB 19 Real. Art LC PCR Reagents (QIAGEN Diagnostics), Light. Cycler 1. 2 (Roche) 2 CAP for TNAI HAV/PVB 19 Real. Art LC PCR Reagents (QIAGEN Diagnostics), Light. Cycler 2. 0 (Roche) DRK-BSD NSTOB & West 19 th So. GAT Meeting, 14/15 June 2006, Bern
Samples tested Pool size BSD NSTOB 668, 469 BSD West (11/2005 – 05/2006) (07/2005 -05/2006) 96 842, 751 Failure rate HCV: Ø 1. 68 % HIV-1: Ø 0. 15 % HBV: Ø 0. 14 % 0. 9 % (hardware error) HCV: Ø 0. 27 % HIV-1: Ø 0. 12 % HBV: Ø 0. 05 % < 0. 2 % (clot, hardware error) NAT only positives HIV-1: 2 (06) HBV: 1 (06) HCV: 2 (05) 2 (06) HBV: 1 Invalidity rate (HCV / HIV-1 / HBV) DRK-BSD NSTOB & West 19 th So. GAT Meeting, 14/15 June 2006, Bern
95% detection limits BSD NSTOB BSD West HBV 675 IUWHO/ml SD 251 IUWHO/ml SD HCV 582 IUWHO/ml SD 624 IUWHO/ml SD HIV-1 4315 IUWHO/ml SD 7876 IUWHO/ml SD PVB 19 5784 IUWHO/ml SD 5735 IUWHO/ml SD HAV 21420 IUWHO/ml SD 6157 IUWHO/ml SD SD = single donation in pool of 96 samples DRK-BSD NSTOB & West 19 th So. GAT Meeting, 14/15 June 2006, Bern
6 a. m. DRK-BSD NSTOB & West 2 h 3 h 15‘ 2 h 40‘ HBV 1 h HIV-1 HCV 0, 5 h R D esu at lt a Tr Va an lid sf ati er on (L IM S) & Am D p et li ec fic tio at n ion C Sa AP m /C pl TM e Pr M ep ai ar nte at na io n n ce N A Ex tra ct io n Po ol in g Turn around time 2 h 10‘ HAV/PVB 50‘ 15 -30‘ ~1 p. m. 19 th So. GAT Meeting, 14/15 June 2006, Bern
Pros & Cons of CAP/CTM 96 System Pro Con 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 DRK-BSD NSTOB & West 19 th So. GAT Meeting, 14/15 June 2006, Bern
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