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An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use
Uliana Danilenko1, Hubert W Vesper2, Gary L Myers3
1Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Hwy NE, MS F25, Atlanta, GA 30341, USA, Phone: +770-488-7346.
Insights
This study updates a protocol for preparing commutable pooled serum reference materials. These materials are essential for accurate calibration and quality assessment in clinical laboratories, ensuring reliable diagnostic testing.
Area of Science:
- Clinical Chemistry
- Laboratory Medicine
- Reference Materials Science
Background:
- Commutable reference materials are crucial for metrological traceability in in vitro diagnostics.
- Existing guidelines (CLSI C37-A) provided a foundation for preparing pooled serum, but enhancements are needed.
- There is a continuous need for stable, commutable matrix-based reference materials for laboratory calibration and quality assessment.
Purpose of the Study:
- To update and enhance a protocol for preparing frozen human serum pools with minimal matrix alteration.
- To ensure the prepared reference materials exhibit commutability with individual human serum samples.
- To provide comprehensive guidance for the production of reliable reference materials for medical laboratories.
Main Methods:
- Detailed step-by-step guidance for planning, serum collection, processing, and pool qualification.
- Procedures for manufacturing frozen serum pools from individual human serum units.
- Incorporation of experience and technical enhancements beyond the original CLSI C37-A guideline.
Main Results:
- An updated protocol for preparing frozen human serum pools that are likely to be commutable with individual samples.
- The protocol addresses minimal matrix alterations to preserve sample integrity.
- Guidance on quality control and documentation for the final reference material product.
Conclusions:
- The updated protocol ensures the continued availability of high-quality, commutable pooled serum reference materials.
- This resource supports accurate calibration and external quality assessment in clinical and diagnostic laboratories.
- The enhanced procedure meets the evolving needs of medical laboratory measurement systems.
Abstract:
Manufacturers of in vitro diagnostic medical devices, clinical laboratories, research laboratories and calibration laboratories require commutable reference materials that can be used in the calibration hierarchies of medical laboratory measurement procedures used for human specimens to establish metrological traceability to higher order reference systems. Commutable materials are also useful in external quality assessment surveys. In order to achieve these goals, matrix-based reference materials with long-term stability, appropriate measurand concentrations and commutability with individual human specimens are required. The Clinical and Laboratory Standards Institute (CLSI) guideline C37-A (now archived) provided guidance to prepare commutable pooled serum reference materials for use in the calibration hierarchies of cholesterol measurement procedures. Experience using the C37-A guideline has identified a number of technical enhancements as well as applications to measurands other than cholesterol. This experience is incorporated into this updated protocol to ensure the procedure will continue to meet the needs of the medical laboratory. The updated protocol describes a procedure for preparing frozen human serum units or pools with minimal matrix alterations that are likely to be commutable with individual human serum samples. The protocol provides step-by-step guidance for the planning phase, collection of individual serum units, processing the units, qualifying the units for use in a pool and frozen storage of aliquots of pooled sera to manufacture frozen serum pools. Guidance on how to perform quality control of the final product and suggestions on documentation are also provided.
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