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New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)

NCT07173114 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-30

No results posted yet for this study

Summary

Medical biology tests are essential to clinical decision-making. The European Regulation on in vitro diagnostic medical devices (EU/2017/746) requires metrological traceability of the values assigned to calibrators and quality controls, based on reference measurement methods (RMMs) or certified reference materials (CRMs). However, these references are not available for all analyses, limiting manufacturers' ability to comply with regulatory requirements.

The dissemination of traceability relies mainly on CRMs. However, to guarantee the validity of the results, these materials must have sufficient commutability, i.e., behavior comparable to that of native biological samples. This property is also required for external quality controls (EQA) used in external quality control programs. Commutability is an essential condition for avoiding matrix effects and ensuring the reliability of results.

The COMET-MPL project aims to optimize manufacturing processes for commutable, single-parameter, or multi-parameter CRMs and EQA. Evaluate the commutability of these materials in relation to patient samples.

The COMET-MPL project aims to Produce materials suitable for priority analyses: bilirubin, cyclosporine, parathyroid hormone (PTH), human cytomegalovirus, estradiol.

Commutability will be verified by comparing the performance of CRMs and EQA with that of clinical samples in several French laboratories equipped with automated systems from different manufacturers.

Conditions

  • Hospitalization
  • All Conditions

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Jean-Paul CRISTOL, PUPH · University Hospital, Montpellier

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-09-22
Completion
2026-09-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173114 on ClinicalTrials.gov