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Documentation and traceability

Assay Performance Verification & Claim Support

Formal assay performance verification or “claim support” studies on your fully-developed assay are a key step on the way to product launch - they form the gateway to critical regulatory activities such as CE-marking, US FDA 510(k) or PMA submissions and their equivalents in other countries. 
Claim support documentation will receive the highest level of scrutiny from regulators, so it is crucial that the correct procedures are followed with respect to protocols and reports, and that the technical designs of the studies meet globally-accepted expectations. Our experts at Fleet Bioprocessing are fully conversant with the relevant IVDD/IVDR and FDA requirements, and widely-accepted technical guidelines such as those published by the Clinical & Laboratory Standards Institute (CLSI).
Simplistically, the assay performance verification process can be summarised by the following sequence:
  • Approval of a performance verification plan which lists all the studies required necessary to demonstrate acceptable assay performance and provides a rationale for this assessment.
  • Approval of a series of performance verification protocols which detail the studies to be carried out and state the acceptance criteria for the results.
  • Execution of the studies described in these protocols.
  • Approval of a series of performance verification reports, each summarising the results obtained, resolving any deviations or discrepancies vs. the acceptance criteria, and stating an overall PASS/FAIL outcome.
  • Approval of a summary performance verification report – based on the structure of the initial plan – which summarises the results from each of the individual reports and states the overall final status.
These studies can be carried out in-house at Fleet, but it is typically also necessary for clinical studies to be carried out in specified countries in a working clinical laboratory environment. We can help you to find the best collaborators for these crucial studies.
A successful design review at the end of the performance verification program will typically give the go-ahead for licensing, marketing, manufacturing transfer and other critical activities as the ramp-up towards launch begins in earnest.
Precision and accuracy
CLSI guidelines

Example Projects

Claim support program for allergy assay range generates over 500 reports!

Over an extended period, Fleet coordinated and performed over 500 claim support and stability studies for an automated allergy platform. This required extensive and detailed planning to avoid scheduling conflicts and to manage long term stability studies. This range of assays has subsequently been successfully launched to market globally.

Fleet performance verification study allows CE-marking of ELISA for novel cardiovascular marker

An ELISA for a novel cardiac marker was developed for a French company, and successfully put through a full performance verification program which allowed it to be CE-marked.

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