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Independent Laboratory Validation
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The independent validation verifies the method performance observed in
the method developer’s laboratory using viable Bacillus anthracis cultures.
The independent laboratory assessed method performance including
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1) probability of detection (POD) at the acceptable minimum detection level (AMDL)
or lower
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2) inclusivity
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3) exclusivity
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4) environmental interference
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Certified reference materials were used for POD repeatability dynamic range and specificity
,
,
testing. Other reference materials are used for inclusivity, exclusivity and environmental
factors testing.
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Robustness testing (instruments and people)
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Shelf life testing of Developer Kits
Multicenter Validation Testing
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Identify test centers
A
li
i h CDC l i
d F d l l
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ssure comp ance w t
regu at ons an e era aw
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Identify individuals not associated with developer or independent
laboratory to do the testing.
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Determine the acceptable skill of testers
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Determine when testing will be done
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Assure administrators, safety officers and support staff are qualified, aware and
support the project
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Have a well vetted test plan in place with easy data recording instructions
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Assure samples can be sent to receiving laboratories
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level Randomize and blind code the subsamples
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Conduct testing over a short period of time if possible
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Record results (pos or neg) for each primer pair and each sample