SPADA Book - April 11, 2017

TM Rigor for Nucleic Acid Testing

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

7

Test Sample Concentrations for Nucleic Acid Testing

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

8