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Evolving calibration hierarchies for diabetes diagnostics

Improved measurements of C-peptide could lead to benefits for people with diabetes. A report recently published in Clinical Chemistry highlights the importance of calibration hierarchies in harmonizing C-peptide measurements to a common reference to enable comparison of results using different assay methods.

The special report ‘Implementing a Reference Measurement System for C-peptide: Successes and Lessons Learned’, produced by Clinical Chemists in collaboration with National Metrology Institutes (NMIs) from around the world, including the BIPM, highlights the advantages of a new reference measurement system for C-peptide and identifies further requirements to ensure the successful implementation and sustainability of the system. It also provides an overview of the general process of harmonization and standardization and the challenges encountered with implementing a new reference measurement system. The reference measurements system described in the report are supported by the CCQM-K115 key comparison coordinated by the BIPM together with NIM, China, which allowed nine NMIs to compare their capabilities for value assigning peptide primary reference materials such as C-peptide.

The production of reference materials, the development of reference measurement procedures, and the provision of reference measurement services often occur in different laboratories, making it essential for these organizations to work together to ensure consistency of results within the traceability chain.

Benefits of measuring C-peptide

In diabetes patients, a measurement of C-peptide blood serum levels can be used to distinguish between certain diseases with similar clinical features. As C-peptide is secreted in equal amounts to insulin but is eliminated much more slowly from the body, measuring it helps to determine the level of natural insulin a person is producing, even if they receive insulin injections. Reliable measurements of C-peptide can be used to assist classification and management of insulin-treated patients.

It is therefore important that C-peptide measurements be harmonized to a common reference to compare and interpret results across various clinical trials and other research studies.

Making metrological traceability mandatory

With the implementation of the European Union Directive (now a regulation) on in vitro diagnostic (IVD) devices, the metrological traceability of calibration and control materials for IVD became mandatory. Although an EU Directive, this created a worldwide effect on clinical laboratory measurements as these devices are found on global markets.  Following the work carried out by the Joint Committee for Traceability in Laboratory Medicine (JCTLM), an international committee created in 2002 by the Bureau International des Poids et Mesures (BIPM), International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and International Laboratory Accreditation Cooperation (ILAC), a database now exists to help industry meet regulations, by identifying available reference materials, methods and services that can be used to comply with metrological traceability requirements.

Read the special report

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