Alternative Test Methods: Validation and Regulatory Status

Conventional test method Alternative Test Method Infor- mation Last Updated
Name & Description Validation Status Regulatory Status Effect or Potential Effect on Animal Use
Food Safety

Mouse Bioassay (PSP) (Association of Official Analytical Chemists [AOAC] Official Method 959.08)

 Jellett Rapid Test (formerly MIST AlertTM test)
Description and references

Not formally validated

FAO/WHO: accepted as a screening test (it is not accepted as a stand-alone test because it is a qualitative method) (Codex Tentative Method of Analysis, Type IV) (2004) 

US: Accepted by the USDA for use by the US National Shellfish Sanitation Program (2004)

Reduction
(Reduction of animal use by up to 30%)

 April 2009
Pre-column HPLC Method (Lawrence method)
Description and references

Association of Analytical Communities (AOAC): validated through collaborative trial (2005)

EU: Inter-laboratory validation study using AOAC official method 2005.06 organized by the Community Reference Laboratory of Marine Biotoxins (CRLMB) concluded that the test can be useful as a screening method but needs further work to implement it for Official PSP Control and as a Reference Method at the EU (2007)

AOAC Official Method 2005.06

FAO/WHO: accepted as a screening test (Codex Type IV method [Tentative Method of Analysis]  but could be promoted to Type III [Alternative Approved Method of Analysis] through further validation studies)		 Replacement April 2009

List of Abbreviations