36 / 140
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:
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”
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
”
Current
Proposed
Neither has language for results reporting, such as:
“Full results from all soils and matrices tested shall be
submitted.”