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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
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NRL’s Activities Evaluations of Test Kits Quality Management Performance Monitoring Methods: QC Monitoring Specificity Batch Delivers reports and programs to generate quality in laboratories EQAS Reference and QA sample testing Testing strategy development *Education
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I-Collaborations Sample characterisation Panel Distribution Sourcing samples Sample selection Sample manufacture Results collection Results analysis Reports KEY AcroMetrix HealthMetrx NRL QC EQAS Digital PT
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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 Facilitating a QC programme in real time NRL application (https://www.nrlqa.net).
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* 2 Plasma samples
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Data entered in 2005 for Selected Assays
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Monitoring Precision & Accuracy S/Co 0 2 4 6 8 10 12 14 Mean Mean+2SD Mean-2SD ABCDEFGHIJ
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Performance of QC sample hivspy004 06/2002 - 10/2003 (7 Laboratories) BatchNmean SD -2SD+2SDMinMaxCV 01170123017.752.2513.2522.257.6529.8412.68 20315979317.342.6612.0222.660.0523.3415.34 207123128817.892.5612.7723.010.1324.2414.31 208146182517.842.5512.7422.940.3928.0014.29 2100961618.603.6711.2625.947.2922.8519.73 21050993318.103.0811.9424.263.2626.1517.02 TOTAL508517.822.6712.4823.160.0529.8414.98
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Precision - CV (%) 051015202530 Accuracy - Bias (%) -30 -20 -10 0 10 20 30 instruments testing HCV instruments testing HBsAg instruments testing HIV instruments testing HTLV Accuracy and Precision of the Abbott PRISM Bias - difference between mean ratio for individual laboratory and mean ratio for all laboratories, expressed as % of mean ratio for all laboratories
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Variation by Laboratory 12 3 4 5 6 7 Laboratory 25 20 15 10 5 0 S/Co
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Variation by Batch
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Ongoing monitoring of Changes in Performance
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