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Showing the boundaries of IVD cross-reactivity claims

Connect evaluation of related targets to the intended analyte and population.

Representative research photograph: Showing the boundaries of IVD cross-reactivity claims
Photo: EU2016 NL from The Netherlands · License: CC BY 2.0 · Cropped and resized.
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Response to something other than the intended target needs assessment within the method and clinical context. Reducing cross-reactivity assessment to a completed checkbox can hide which related targets were actually studied.

Define the assessment

Define the intended analyte and why related targets were selected. Material identity, preparation and represented conditions should remain traceable. Do not combine cross-reactivity with every other interference mechanism under an unclear label; readers should understand the question examined.

Worked example

For example, a related target produces a positive output in a new assay. The team does not immediately declare every clinical positive incorrect. It investigates material identity, experimental conditions and target definition, then links the finding to intended-population relevance and further evidence needs. One experiment does not establish all related targets.

Practical checks

  • Document biological or technical reasons for selecting related targets.
  • Link material identification and preparation records to each result.
  • Present favourable and unfavourable findings with tested conditions and measurement ranges.

Decision and limitations

The report should identify targets and conditions examined. A negative experiment cannot exclude every untested target. Qualified reviewers assess clinical interpretation and route implications for instructions and risk into the relevant processes. This assessment is not individual diagnostic or treatment advice.

Frequently asked questions

Does response to a related target invalidate all results?
Not automatically. Examine scope, target definition and clinical context together.
Do a few negative experiments establish complete coverage?
Justify scope and avoid unconditional exclusion claims for targets not studied.

Sources

  1. MDCG 2022-2 — IVD clinical evidence principles
  2. MDCG 2025-5 — IVD performance studies