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TM Rigor for Nucleic Acid Testing
7
Level 1
Full AOAC SMPR inclusivity and exclusivity nucleic acid panels (where
applicable)
Level 2
~1/2 AOAC SMPR inclusivity and full exclusivity nucleic acid panels
Level 3
A single representative organism nucleic acid inclusivity strain
Full exclusivity panel
Test Sample Concentrations for
Nucleic Acid Testing
8
Inclusivity test sample concentration: 10,000 GE/mL
Must meet or be lower than the concentration required to meet the needs of
the end user/application (e.g., field screening of
visible
suspicious powder)
Can be set lower than needed for the application, based on the capabilities of
the technology, but should not be set so low that otherwise acceptable
products can not achieve metrics
Exclusivity test sample concentration: 100,000 GE/mL (10X inclusivity
concentration)
Powder test sample concentration: 0.1 mg/mL