AOAC SPADA Meeting

3/11/2020

CHALLENGES: CULTURE VERIFICATION

Historical information may not be available, incomplete or incoherent:

History has to start with documentation at some point. Study sponsors can determine if information is adequate or if additional verification testing is needed.

Propagation protocols may be proprietary: Culture producer should have the step-by-step procedure recorded, but it is possible that some information needs to be redacted. Study sponsors can determine if this is acceptable or if additional information is needed Culture Verification and Orthogonal Testing: Culture verification requires the historical documentation and propagation protocols. There is not a list of assays that are required for verification. This could be cost prohibitive to many laboratories. Instead, assays are to be selected by the culture producers for their verification.

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CHALLENGES: APPLICATION SPECIFIC TESTING Challenge to this specification was how to consolidate application specific testing results as part of a provenance statement or Culture Verification statement. This activity requires curation of the Culture Verification statements, which could be labor intensive.

This is a nice to have but not required for the Culture Verification statement. If it is included, it should demonstrate an alignment between the test sample and index cultures.

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