New version: NordVal Protocol 1 Validation for Microbiology
NordVal International Protocol No. 1 Validation of microbiological alternative (proprietary) methods against a reference method version June 2026 is available here: Validation protocols – NMKL
The protocol follows the EN ISO 16140-2: Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method.
New in the version of June 2026 (29.06.26):
- The protocol has been aligned with ISO 16140-2 Amd 1, except for the recognised errors in the amendment, and LOD has been included as described.
- For qualitative studies, new formulas have been included for both MCS and ILS.
- For the ILS, calculations are included for paired studies only (not unpaired studies).
- For quantitative studies, the Excel file includes Bland–Altman plot and Accuracy Profiles for both MCS and ILS, organized in separate worksheets. For the Bland–Altman analysis, there is a minor modification to the confidence factor, using 1.96 instead of 2, i.e. no big change for the plots.
- For the Accuracy Profile, the ISO spreadsheets are recommended.