AOAC SPADA Meeting

Bacterial Verification

Considerations for Verification

Is it sufficient to identify the species or go down the strain level? The critical attributes need to be  identified to know what to test.  

Are there different tiers or “Quality Grades” of verification?  Strain verification should include the minimum  attributes required to identify the strain. Additional testing  should not be necessary to verify identity.  

Do we need to be accurate or consistent?  Does everyone have an isolate the measures up to the type  strain?  Or does everyone have an isolate that is equivalent to everyone else’s isolate? 

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Bacterial Verification

What happens if the critical attributes for the strain cannot be identified ? 

Think about Francisella tularensis  subsp. holarctica LVS/ Francisella tularensis  LVS/ Francisella LVS/Francisella holarctica  LVS.  Which strain of the strain do you have?

In this case, if the critical attributes cannot be identified, then moving to validation might be the answer.

That is, all users would have to confirm that their isolate has the same LD50 in a  mouse model or perform  the same in an AST,  have the same growth rate on a particular media, etc. 

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