New Approaches for Evaluating the Interchangeability of Reference Materials and Quality Controls (COMET-MPL)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier
About this trial
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
This trial does not accept healthy volunteersQualifiers
Panel 1: adults ≥ 18 years of age.
Panel 2: adults ≥ 18 years of age undergoing immunosuppressive treatment (cyclosporine, everolimus, tacrolimus, sirolimus).
Disqualifiers
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
Trial population
The population consists of patients hospitalized in the departments of the investigative teams at Montpellier University Hospital, regardless of their pathologies.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Panel 1
Group B: Panel 2
Trial outcomes
Primary outcomes
1
Assessment of Commutability
The primary endpoint is the analytical data associated with the biomarker in question obtained from the blood sample: commutability will be assessed by comparing the behavior of certified reference materials (CRMs) and external quality controls (EQA) with the results from fresh serum.
Time frame
1 daySecondary outcomes
1
Serum Testosterone Concentration
Measured concentration (ng/dL) in patient serum samples using standardized laboratory methods
Time frame
1 day2
Serum Calcium Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Time frame
1 day3
Serum Glucose Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Time frame
1 day4
Total Cholesterol Concentration
Measured concentration (mg/dL) in patient serum samples using standardized laboratory methods
Time frame
1 daySponsors and contacts
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Source ClinicalTrials.gov