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6. Interpretation examples and additions
A few case studies illustrate the flexible application of the accuracy profile, whatever the analytical procedures to be validated.
6.1 Additions dosed by weighing: level realignment
Sometimes, the analyte under study is not easy to bring into solution. This poses a problem if you have decided to use the dosed addition method to establish reference concentrations, as weighings are likely to differ from one addition to the next. To compensate for these systematic biases, the addition concentrations can be realigned.
If we denote X
i(k)
, the addition of series i for level k, we can calculate an average for level k, denoted
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Interpretation examples and additions
Practical calculation of validation criteria
Bibliography
Software tools
There are few software packages dedicated to method validation. Arlenda ( http://www.arlenda.com/ ) has developed one called "e-noval®". It uses the accuracy profile and produces a certified report. Its originality lies in the fact that it operates via the Internet (Web-based solution): the user copies the data into an Internet interface,...
Websites
AOAC (Association of Official Analytical Chemists): originally American, this association of analysts has become international. In addition to its standardizing role, it validates methods according to various protocols http://www.aoac.org/
EURACHEM, a network of European organizations whose aim is to set up a forum for the traceability...
Standards and norms
Association française de normalisation Afnor
- Water quality – Protocol for initial assessment of method performance in a laboratory - NF T90-210 - 2009
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais - NF EN ISO/CEI 17025 - 2005
- Laboratoires d'analyses de biologie médicale....
International Organization for standardization ISO
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