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Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT

Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT. Wayne Dimech, Darren Jardine, Thu-Anh Pham and the staff of the NRL. Presentation Outline. NRL’s ever-widening role in QA Why Internet-based technology (IT)

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Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT

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  1. Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT Wayne Dimech, Darren Jardine, Thu-Anh Pham and the staff of the NRL

  2. Presentation Outline • NRL’s ever-widening role in QA • Why Internet-based technology (IT) • IT implications and examples for: • External quality assessment schemes (EQAS) • Quality control (QC) programmes • Specificity monitoring • Summary - effective quality monitoring

  3. NRL’s Ever-widening Role in QA • Monitors the performance of in vitro diagnostic (IVD) reagents for BBV in Australia including nucleic acid testing (NAT) • Provides quality assurance internationally (200+ laboratories) • Extending collaborations with like organisations • Developing IT to support its client laboratories

  4. Why Internet-based Technology • Standardise data collection and storage • Manage increasing data complexity • Improve maintenance of data • Offer better statistical analyses • Give instant feedback to laboratories to ensure their ability to monitor performance • Individualise reporting • Offer easy administration of QA functions • Offer international accessibility • Facilitate international collaborations

  5. NAT EQAS Design • EQAS for NAT are designed to examine • Limits of detection • Inter- and intra-run variability • Contamination/carry over • Inhibition • Instrument/method variability • Develop QC samples • Geno-subtype detection

  6. IT Implications on NAT EQAS • NAT EQAS concepts in DigitalPT • Assay • Test Process • Kit • Instrument • Analyte • Unit

  7. DigitalPT Concepts Laboratory Assay Extraction Amplification Detection Kit Kit Kit Technique Technique Technique Kit: Roche MagNA Pure LC TNA Isolation Kit Instrument: MagNA Pure Instrument Instrument Instrument Kit: Roche COBAS Amplicor HIV-1 Monitor v 1.5 Instrument: COBAS Amplicor Kit: Roche COBAS Amplicor HIV-1 Monitor v 1.5 Instrument: COBAS Amplicor Analyte Analyte Units

  8. IT Implications on Quality Control • Collects, stores and analyses QC data • Allows for inter-laboratory comparisons • Requires peer groups for assessment of accuracy • Can monitor imprecision and bias • Can identify sources of variation

  9. Quality Control Information • Data collected can be used to • Monitor reagent batches • Troubleshoot laboratory problems • Provide oversight of regional laboratories • Review QC sample stability • Collect information for assay standardisation • Calculate uncertainty of measurement

  10. Chlamydia NAT QC Programme • Roche COBAS Amplicor Chlamydia • QC sample produced by NRL • 18 month period • 15 laboratories, 28 instruments • 3,570 observations; • CV (%) of all results = 9.14% • CV (%) ranged from 4.31 - 16.12%

  11. Chlamydia NAT QC Summary Laboratory C: CV(%) COBAS 5 5.96 COBAS 4 6.19 COBAS 2 9.95 COBAS 1 10.51 COBAS 3 12.00 Mean: 3.52 to 3.86 287 18

  12. Blood screening NAT QC Summary • Three Chiron TMA assays monitored • Period of 15 months • 21 laboratories, 31 instruments • Two batches of QC samples for each analyte (HBV, HCV and HIV) • More than 16,000 data entries

  13. Blood screening NAT QC Summary

  14. Blood screening NAT QC Summary

  15. Blood screening NAT QC Summary

  16. Chiron TMA - Duplex Results of two batches of AcroMetrix PeliSpy Pro samples tested in the Chiron Duplex TMA Assays HCV HIV A B A B QC sample batches

  17. Chiron TMA - Ultrio Results of two batches of AcroMetrix PeliSpy Pro samples tested in theChiron ULTRIO TMA Assays HCV HIV HBV A B A B A B QC sample batches

  18. HCV HIV HBV A B A B A B QC sample batches Chiron TMA - TIGRIS Results of two batches of AcroMetrix PeliSpy Pro samples tested in theChiron TIGRIS TMA Assays

  19. IT Implications on Specificity Monitoring • Collects and analyses the initial (IRR) and repeat reactor rates (RRR) and compares them with confirmed positive rate • Monitors assay and laboratory performance • Increase in IRR may indicate contamination • Results may be analyzed in conjunction with QC results

  20. Conclusion • Internet technology allows: • More complex data collection and analysis • Standardisation of data collection • International participation • Greater scalability • Facilitation of collaboration • Immediate feed back to oversight bodies and manufactures on assay performance

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