Abstract
Reproducibility of analytical systems over time is essential for monitoring of individual patients, as well as for the application of reference intervals and other medical decision limits. Variation between different manufacturer lots of reagents and calibrators can contribute to significant variation in laboratory measurements and hence to patient results over time. The assessment of reagent and calibrator lots represents a significant challenge for laboratories and different approaches have been taken for acceptance testing of new lots. The Clinical Laboratory Standards Institute (CLSI) has published an evaluation protocol EP26-A for the assessment of new reagents although it has been criticised for being difficult to implement. Other approaches have been published as pragmatic alternatives to the CLSI protocol. The aim of this session will be to briefly review the CLSI protocol and published alternatives for the assessment of lot variation in reagents and calibrators.
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