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Lutz Pichl , DRK-Blutspendedienst West Christine Jork, DRK-Blutspendedienst NSTOB. 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.

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evaluation data on the new roche cobas s 201 system with the cobas taqscreen mpx test
Lutz Pichl , DRK-Blutspendedienst West

Christine Jork, DRK-Blutspendedienst NSTOB

Evaluation data on the new Roche cobas s 201 system with the cobas TaqScreen MPX test

Lutz Pichl, Volkmar SchottstedtGerman Red Cross Blood Transfusion Service West,

Hagen, Germany

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 HBVby multiplex PCR in a large blood bank setting

Aim of the study
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

Conditions
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)

Cross-Contamination Study
reproducibility
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 daysby 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.

Potential interference with endogenous substances
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

Genotype Inclusivity