Page 63 - 2013 ISPAM Mid-Year Mtg Book

3/7/2013
10
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.