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Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based Application

Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based Application. Elizabeth M. Dax for the staff of the National Serology Reference Laboratory. NRL’s Activities. Evaluations of Test Kits. Performance Monitoring Methods: QC

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Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based Application

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  1. Ongoing Standardisation of Testing for Blood-Borne Pathogens through an Internet-based Application Elizabeth M. Dax for the staff of the National Serology Reference Laboratory

  2. NRL’s Activities Evaluations of Test Kits Performance Monitoring Methods: QC Monitoring Specificity Batch Reference and QA sample testing Testing strategy development*Education Quality Management EQAS Delivers reports and programsto generate quality in laboratories

  3. EQAS QC KEY Digital PT AcroMetrix HealthMetrx NRL I-Collaborations Sourcing samples Sourcing samples Sourcing samples Sample selection Sample characterisation Sample manufacture Panel Distribution Panel Distribution Panel Distribution Results collection Results analysis Reports

  4. Facilitating a QC programme in real time • EDCNet • Internet-based QC monitoring system • Laboratories submit data into ‘live’ data • graphically displays data in charts • instantaneous and confidential • Inter- and -intralaboratory variation • monitors performance of instruments, reagents and operators • NRL application (https://www.nrlqa.net).

  5. * 2 Plasma samples

  6. Data entered in 2005 for Selected Assays

  7. 14 12 10 S/Co 8 6 4 2 0 Monitoring Precision & Accuracy Mean+2SD Mean Mean-2SD A B C D E F G H I J

  8. Performance of QC sample hivspy004 06/2002 - 10/2003 (7 Laboratories)

  9. Accuracy and Precision of the Abbott PRISM 30 20 10 Accuracy - Bias (%) 0 -10 -20 -30 0 5 10 15 20 25 30 Precision - CV (%) instruments testing HIV instruments testing HTLV instruments testing HBsAg instruments testing HCV Bias - difference between mean ratio for individual laboratory and mean ratio for all laboratories, expressed as % of mean ratio for all laboratories

  10. Variation by Laboratory 25 20 15 10 5 0 S/Co 1 2 3 4 5 6 7 Laboratory

  11. Variation by Batch

  12. Ongoing monitoring of Changes in Performance

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