75 / 88
OMB Expectation Parameters
Single Laboratory
Validation
Reproducibility/
Uncertainty
Comparison to
Standard/
Acceptance Criteria
Qualitative methods: inclusivity
Documented method
(or equivalent), exclusivity (or
equivalent), robustness,
repeatability, POD (or equivalent),
cross reactivity, matrix scope,
etc…
Qualitative methods: ‐ probability
of detection or equivalent
performance versus a SMPR,
recognized reference standard
(materials), recognized reference
method, or general method end
user community guidance and/or
acceptance criteria
Quantitative methods:
demonstrated method linearity,
Quantitative methods:
Document reasons for
accuracy, repeatability,
selectivity, LOD/LOQ, Matrix
scope, etc….
demonstrated method
reproducibility and/or uncertainty
acceptability if it doesn’t meet the
standard or acceptance criteria