SPADA Book - April 11, 2017

Reason 3: SMPRs already contains performance requirements for environmental matrix testing • System false‐negative rate using spiked  environmental matrix materials ≤5% • System false‐positive rate using environmental  matrix materials ≤5% Is a footnote needed to recognize that some soils or  matrices might actually contain the target organism?   Such as: “Rates of ≤5% are expected.  All discrepancies are to  be…”  (reported?  Retested? Other?)

If soil testing moves to Part 1, we must reconcile:

Current

Proposed

Interferants/inhibition – “spiked at 2x, 5x and 10x AMDL  with the archetype organism” – Specifies use of “ intact target  organisms ” Cross‐reactivity/specificity – Evaluate “for any  signs of  positive response ”

Interferants/inhibition – “target biological threat agent 

sufficient to achieve 95%  probability of detection ”

Cross‐reactivity/specificity – “include  sufficient samples  and replicates  to ensure each  environmental condition is  adequately represented”

Neither has language for results reporting, such as:  “Full results from all soils and matrices tested shall be  submitted.”