Module 9 2021

24/03/2021

Assay design & stats analysis

Is the assay valid? • AAC passes.. • Apply 2nd line of scrutiny – Sample Acceptance Criteria

pass

SAC each sample

AAC

The Organisation for Professionals in Regulatory Affairs

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Assay design & stats analysis

Is the assay valid? • AAC passes… • Apply 2nd line of scrutiny – Sample Acceptance Criteria

pass

SAC each sample

AAC

• If samples pass criteria, each assay constitutes one result for that sample • Multiple assays per sample maybe required to produce a reportable result (n=2 or n=3) • If one sample fails SAC, then that data is not used and the sample is repeated

The Organisation for Professionals in Regulatory Affairs

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