Participant and specimen selection
Track eligibility sampling and specimens
Sampling should represent the intended clinical pathway. Keep participant and specimen identifiers separate, and show the reasons that paired results are unavailable. Excluding hard-to-test patients can change the apparent performance.
Flow diagram
Steps
Define intended-use population
Specify setting, clinical role and disease spectrum.
Recruit representative participants
Define consecutive, random or other sampling with rationale.
Assess eligibility and consent
Document exclusions without selecting on known test outcomes.
Collect and track specimens
Specify handling, timing, adequacy and repeated specimens.
Track paired test availability
Retain missing, indeterminate and unverified outcomes explicitly.
Participant and specimen selection
End flow
Tables and supporting information
Specimen and test availability
Preserve participants with incomplete verification for transparent accounting.