Transcript Document 7816953

Experience with Roche´s COBAS
AmpliPrep/COBAS TaqMan96 automated PCR
system in two large blood bank settings
Christine
Lutz Pichl
Jork,, DRK-Blutspendedienst West
NSTOB
Christine
Lutz Pichl
Jork,, DRK-Blutspendedienst West
NSTOB
DRK-BSD NSTOB & West
19th SoGAT Meeting, 14/15 June 2006, Bern
Springe
DRK-BSD
West
DRK-BSD NSTOB & West
Hagen
DRK-BSD
NSTOB
19th SoGAT Meeting, 14/15 June 2006, Bern
Donations/year (2005)
Samples/Day
BSD NSTOB
1.15 mio
~ 4.000
BSD West
1.26 mio
~ 4.000
Viral parameters
HCV, HIV-1, HBV, HAV, PVB19
Routine testing with
CAP/CTM96 since
1st Nov. 2005
1st July 2005
6x
9x
CAP/CTM96 Systems
DRK-BSD NSTOB & West
19th SoGAT Meeting, 14/15 June 2006, Bern
System configuration
BSD NSTOB
CAP/CTM96 combined via docking
station for HBV, HCV and HIV-1
BSD West
CAP/CTM96 combined via docking
station for HBV, HCV and HIV-1
+ ventilation shaft for waste air
2 CAP/CTM96 for HCV
3 CAP/CTM96 for HCV
2 CAP/CTM96 for HIV-1
3 CAP/CTM96 for HIV-1
1 CAP/CTM96 for HBV
3 CAP/CTM96 for HBV
1 CAP for TNAI  HAV/PVB19
RealArt LC PCR Reagents
(QIAGEN Diagnostics),
LightCycler 1.2 (Roche)
2 CAP for TNAI  HAV/PVB19
RealArt LC PCR Reagents
(QIAGEN Diagnostics),
LightCycler 2.0 (Roche)
DRK-BSD NSTOB & West
19th SoGAT Meeting, 14/15 June 2006, Bern
Samples tested
Pool size
Invalidity rate
(HCV / HIV-1 / HBV)
Failure rate
NAT only positives
DRK-BSD NSTOB & West
BSD NSTOB
BSD West
668,469
842,751
(11/2005 – 05/2006)
(07/2005 -05/2006)
 96
 96
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)
HIV-1: 2 (06)
HBV: 1 (06)
HCV: 2 (05) 2 (06)
HBV: 1
19th SoGAT 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
PVB19
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
19th SoGAT Meeting, 14/15 June 2006, Bern
Turn around time
0,5 h
1h
6 a.m.
DRK-BSD NSTOB & West
2h
HIV-1
3h 15‘
HCV
2h 40‘
HBV
2h 10‘
HAV/PVB 50‘
15-30‘
~1 p.m.
19th SoGAT Meeting, 14/15 June 2006, Bern
Pros & Cons of CAP/CTM96 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
19th SoGAT Meeting, 14/15 June 2006, Bern