2013 ISPAM Mid-Year Mtg Book

3/7/2013

 For Qualitative methods, ISO and HC agree:100% (comparative) sensitivity is required to demonstrate acceptability or fitness-for-purpose, i.e. All samples must be correctly identified  For Quantitative methods, for acceptable precision as suggested by HC, the repeatability (r) must be less than half of the reproducibility (R)

data. 2r < R. If R value if published.  If there is no published performance characteristic data, ???

 For Quantitative methods, ISO proposes to accept:  participation in interlaboratory comparisons such as proficiency testing and plotting z-scores to show any trends;  use of microbiological RM or CRM;  recovery experiments with spiked samples using a non-selective method .

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