NCT07173114 New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
| NCT ID | NCT07173114 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Hospitalization |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-22 |
| Primary Completion | 2026-09-22 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * Panel 1: adults ≥ 18 years of age. * Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus). Exclusion Criteria: * Protected patients (minors who are not emancipated, individuals who are unable to express their consent, etc.) * Individuals who are not affiliated with a social security system * Individuals under judicial protection * Refusal to give consent to participate in the research