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A Nordic reference serum suitable for use as trueness control in the clinical routine laboratory
O Blaabjerg1, P Elg, W Gerhardt
1Department of Clinical Chemistry, Odense University Hospital, Denmark.
Insights
This study details the creation of a high-quality reference serum for laboratory diagnostics. It ensures accurate and reliable patient test results through rigorous production and traceability standards.
Area of Science:
- Clinical Chemistry
- Biotechnology
- Laboratory Medicine
Background:
- Establishing reliable reference materials is crucial for accurate clinical diagnostics.
- Existing reference materials may lack sufficient characterization or traceability.
- The NORDKEM project aims to address these limitations by developing a superior reference serum.
Purpose of the Study:
- To describe the characterization and production of a novel human reference serum.
- To provide guidance on establishing and utilizing such reference materials in practice.
- To ensure traceability and define acceptable uncertainty levels for assigned values.
Main Methods:
- Human serum processed under aseptic conditions, with cryoprecipitate and fibrin removed.
- Ultracentrifugation for clearing, pH adjusted to 7.2-7.6, and stored at -80°C in sealed ampoules.
- Production adheres to Good Manufacturing Practices (GMP), ensuring homogeneity and stability.
Main Results:
- The reference serum is characterized by minimal protein damage, specified analytes, and traceability to highest metrological standards.
- Proposed maximum allowable uncertainty is based on biological variation, ideally below 1/5 of maximum allowable bias.
- The material is suitable for ensuring accuracy in routine clinical laboratory analyses.
Conclusions:
- The developed reference serum meets stringent quality criteria for reliable diagnostic testing.
- The proposed uncertainty framework ensures clinical relevance and diagnostic efficacy.
- This work provides a practical model for establishing advanced reference materials in clinical chemistry.
Abstract:
The described reference serum is characterized by: liquid human serum at "normal" level stored in frozen state at -80 degrees C; minimum damage of proteins; aseptic preparation; cryoprecipitate and excess fibrin removed; serum cleared by ultracentrifugation; pH at 7.2-7.6; available in sealed glass ampoules with inert gas (one ml serum in each); specified components among most frequently analyzed analytes; homogeneity assured and stability monitored; produced under strict rules for good manufacturing practices (GMP). The assigned values are traceable to reference measurement procedures and reference materials of highest achievable metrological level; according to the present proposal the maximum allowable uncertainty of the assigned value is based on biological variation (shared common reference intervals); the uncertainty should ideally not exceed 1/5 of the maximum allowable bias of results obtained on patients samples (even 1/2 would theoretically be acceptable and, for a practical guide approximately < 1% may suffice). The present document provides some guidance of how the reference serum could be established in practice. The document also indicates the use of the material and further extension of the concept. The present work is done as a NORDKEM project.
