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Additional reference assessment limited to positive or discordant specimens can alter interpretation of an IVD performance study. If verification pathways are hidden, reported performance may reflect a selected group. Explain the verification process in the design.
Define the assessment
Define how reference assessment is chosen, why it is absent for some participants and how missing information will be handled. Disclose whether knowledge of the new test influences further investigation. Testing needed for clinical care and verification for research can have different rationales.
Worked example
For example, positive new-test results receive extensive investigation, while negatives have only a brief record review. The team does not assume these provide equivalent reference information. It shows how condition status was established, how many negatives remain unverified and the differing pathways behind the result table.
Practical checks
- Map the relationship between new-test results and referral for reference assessment.
- Show verified, unverified and uncertain condition-status counts separately.
- Assess the effect of missing reference information with qualified analytical reviewers.
Decision and limitations
The report should help readers understand a complex pathway rather than hide it. Do not automatically classify unverified people as condition-negative. Explain assumptions and alternative assessments, and avoid implying certainty in the headline that the study could not establish.
Frequently asked questions
- Does a negative result verify absence of the condition?
- The investigational test itself cannot simply substitute for independent verification; assess the reference approach separately.
- Are different verification pathways always invalid?
- Not automatically. Assess the design, reasons and possible bias through appropriate methods.