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.

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Presentation transcript:

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

~ 4,000 - 6,000 samples/ day Hagen

cobas s 201 system

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

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

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)

Reproducibility 3 Run Controls: HBV: 30 IU/ml HCV: 50 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

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.

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 01-466 (group O)  further investigation

Screening minipools (n =96) from blood donations