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Evaluation of the Procleix TIGRIS System at the Blood Transfusion Service Berne Ltd.

Evaluation of the Procleix TIGRIS System at the Blood Transfusion Service Berne Ltd. Dr. Martin Stolz. NAT testing in progress. HCV-PCR since 01 ‘1999 HIV-1 PCR since 03‘ 2002 increased blood safety automized test procedures. Procleix TIGRIS System. fully automated NAT screening system

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Evaluation of the Procleix TIGRIS System at the Blood Transfusion Service Berne Ltd.

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  1. Evaluation of the Procleix TIGRIS System at the Blood Transfusion Service Berne Ltd. Dr. Martin Stolz BTS SRC Berne Ltd.

  2. NAT testing in progress • HCV-PCR since 01 ‘1999 • HIV-1 PCR since 03‘ 2002 • increased blood safety • automized test procedures BTS SRC Berne Ltd.

  3. Procleix TIGRIS System • fully automated NAT screening system • combined detection of 3 viruses: HIV-1, HCV and HBV • extraction/amplification/detection in one tube • extraction based upon magnetic bead technology • amplification based upon the TMA technology using RNA as amplified targed • detection by chemiluminescence • specific discrimination assays for virus identification BTS SRC Berne Ltd.

  4. Design of the evalution study • Assay validation: • sensitivity, specificity, robustness & cross-contamination • Test performance under routine conditions • routine samples • pools of 8 or individual donations • pooling with Tecan pipetting robots • analysis with Procleix TIGRIS system BTS SRC Berne Ltd.

  5. Sensitivity • HIV-1: 24.9 IU/ml(95 % C.I.: 20.2 – 33.3 IU/ml) ca. 13.9copies/ml • HCV: 3.7 IU/ml(95 % C.I.: 3.1 – 4.8 IU/ml)ca. 23.3 copies/ml • HBV: 7.6 IU/ml(95 % C.I.: 6.0 – 11.1 IU/ml)ca. 41.0copies/ml BTS SRC Berne Ltd.

  6. Robustness and reproducibility • Procleix TIGRIS system: excellent robustness against cross-contamination • reproducibility: intra-, inter-assay precision and between laboratories confirmed • reliable test: 3 x 95% positive cut off value (HIV-1: 75 IU/ml, HCV: 11 IU/ml, HBV: 23 IU/ml) • high robustness against inhibiting substances i.e. 100 I.U. heparin per sample • no interference with lipaemic or haemolytic samples as a frequent donation related factor BTS SRC Berne Ltd.

  7. Specificity – System Evaluation *) positive sample was a HBV window period donation BTS SRC Berne Ltd.

  8. Summary • very good test sensitivity, robustness and reliability • clear discrimination between reactive and non reactive samples • low level of invalid samples • elevated level of „false“ positives with pools of 8 observed • pool resolving requires more time and large sample quantities • fully automated NAT screening system • test and software easy to handle • high throughput: single donation testing feasable • very high degree of automatisation, but demanding hardware and little flexibility BTS SRC Berne Ltd.

  9. Acknowledgments • Christiane Schmidseder • Rita Hubschmid • Roger Hellmüller • Dr. Christoph Niederhauser • Dr. Philippe Schneider (BTS Lausanne) • Chiron Corp. BTS SRC Berne Ltd.

  10. Window period HBV donation • identified by single donation testing • donation already transfused at time of testing • recipient developed a HBV viraemie 3 weeks post transfusion • viral load of the initial donation not available, but… • initial HBV titer must have been quite low: no longer detectable in a dilution of 1:8 and 1:24 • 101'621 IU/ml in 2nd donation 35 days later BTS SRC Berne Ltd.

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