NordVal validation protocol

Microbiological analysis

1. NordVal International protocol for validation of alternative (proprietary) microbiological methods agains a reference method 

• The protocol harmonises with ISO 16140-2:2016 and can be downloaded here: NordVal Protocol 1 (Jan 2022) 
• Apendices to NordVal Protocol 1 can be downloaded here:
  • Appendix 1 Sensitivity study: NordVal Prot 1_A1_Sensitivity study.xlsx
  • Appendix 2 Qualitative analysis: NordVal Prot 1_A2_ILS Qualitative analysis.xlsx
  • Appendix 3 Quantitative methods: NordVal Prot 1_A3_Quantitative methods plots.xlsx
  • Appendix 4 Accuracy profile multiple comparison study: A4_AP calculation tool MCS.xlsx
  • Appendix 5 Accuracy profile interlaboratory study: A5_AP calculation tool ILS.xlsx

1B. NordVal International protocol for validation of alternative (proprietary) methods for microbiological confirmation and typing procedures

• The protocol harmonises with ISO/DIS 16140-6 2017-12-15 and can be downloaded here: NordVal Protocol 1B (Jan 2019)

Evaluation forms for reviewers: 

• Evaluation forms for validation of alternative microbiological methods can be downloaded here: 
  • Qualitative evaluation form
  • Quantitative evaluation form 

Chemical analysis

2. NordVal International protocol for validation of alternative (proprietary) chemical methods

• The protocol can be downloaded here: NordVal Protocol 2 (Sept 2018)