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Comprehensive quality control programme for serology and nucleic acid testing using an Internet-based application

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The National Serology Reference Laboratory, Australia (NRL) has quality assured the serology for high risk blood-borne infections since 1985, commencing with anti-Human Immunodeficiency Virus (HIV) enzyme immunoassays and later extending the programmes to other blood-borne virus testing and to nucleic acid testing. A quality control (QC) programme was considered the most appropriate manner in which to achieve real-time monitoring. An Internet-based application, EDCNet, facilitates the entry of results of QC sample testing and returns the analysed results instantaneously. Results can be displayed in a variety of tables and charts, so that QC results from blood service and diagnostic laboratories can be monitored. Comparison of results between laboratories using the same system offers monitoring of accuracy, while within-laboratory comparisons offer monitoring of the assay precision. More than 200,000 data points were submitted to EDCNet in 2002 from blood service laboratories as well as from diagnostic laboratories. Analysis of reagent batch variability was determined, e.g. the coefficient of variation between batches of seven assays used to detect anti-hepatitis C virus (HCV) antibodies ranged from 4.9% to 21.6%. Using EDCNet, laboratories can monitor both precision and accuracy of results by comparison with the results of other laboratories. The system may be a highly cost-effective method for maintaining quality.

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Correspondence to Wayne Dimech.

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Presented at the 8th Conference on Quality in the Spotlight, 17–18 March 2003, Antwerp, Belgium

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Dimech, W., Walker, S., Jardine, D. et al. Comprehensive quality control programme for serology and nucleic acid testing using an Internet-based application. Accred Qual Assur 9, 148–151 (2004).

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