1. Evaluation data on the new Roche cobas s 201 system with the cobas TaqScreen MPX test
Lutz Pichl, Volkmar Schottstedt German Red Cross Blood Transfusion Service West,
Hagen, Germany
Lutz Pichl , DRK-Blutspendedienst West
Christine Jork, DRK-Blutspendedienst NSTOB

2. ~ 4, ,000 samples/ day
Hagen

3. cobas s 201 system

4. Aim of the study
evaluation of the Roche cobas s 201 System in combination with the TaqScreen MPX test
feasibility to screen plasma minipools (pools size  96 samples) for HCV, HIV-1, HIV-1 O, HIV-2 and HBV by multiplex PCR in a large blood bank setting

5. Conditions Fully automated, IVD-conf. , CE-marked system
Focus on the performance of the MPX test rather than on hardware features of the s 201 (lab sample pooling unit and PCR unit with CAP/CTM systems have been operated since 2005 under routine screening conditions) minipools are processed by the integrated Hamilton Microlab Star pipettor like single units

6. Cross-Contamination Study
16 high titre, positive donor samples (5 HBV-DNA pos., 5 HCV-DNA pos., 5 HIV-1 pos.) and 16 non-reactive donor samples in alternating manner of 32 position on 2 racks
titres HBV: 8.0 EE8, HCV: 1.0 EE7, HIV-1: 1.0 EE6
2 different loading schemes were analysed
result: no cross-contamination observed except 1 false (weak-) positive HCV (Ct 46.3 vs. Ct 18.4)

7. Reproducibility
3 Run Controls: HBV: IU/ml HCV: IU/ml HIV-1: 160 IU/ml
8 replicates of each control were analysed on 4 days by 2 operators with 2 different kit lots

8. Potential interference with endogenous substances
Haemolysed plasma samples consisted of up to 20% (v/v) lysed red cell concentrate (12,550 mg/dl Hb)
lipaemic plasma samples (871 mg/dl triglycerides)
“green colored” plasma from female donors under hormonal treatment
Individual plasma samples were seperately spiked with HBV (30 IU/ml), HIV-1M (50 IU/ml) and HCV (160 IU/ml), final concentrations
5 (haemolytic) to 20 replicates (lipaemic/ green) were analysed
 Induced high concentrations of hemoglobin, fat and other possibly interfering substances showed no inhibitory effect on PCR results at definite concentrations.

9. Genotype Inclusivity
NIBSC HCV RNA genotype panel 02/202 for NAT, final conc. 100 IU/ml  all panel members detected
Acrometrix VQC PeliCheck HBV-DNA genotype panel (1,000 cop/ml)  all panel members detected
NIBSC 1st Int. Ref. Panel 01/466 for HIV-1 RNA  all panel members detected except for HIV (group O)  further investigation

10. Screening minipools (n =96) from blood donations