An updated protocol based on CLSI document C37 for preparation of off-the-clot serum from individual units for use alone or to prepare commutable pooled serum reference materials.
Clin Chem Lab Med
; 58(3): 368-374, 2020 02 25.
Article
em En
| MEDLINE
| ID: mdl-31665109
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.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Análise Química do Sangue
/
Coleta de Amostras Sanguíneas
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Soro
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Documentação
Tipo de estudo:
Guideline
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Prognostic_studies
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Qualitative_research
Limite:
Humans
Idioma:
En
Revista:
Clin Chem Lab Med
Assunto da revista:
QUIMICA CLINICA
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TECNICAS E PROCEDIMENTOS DE LABORATORIO
Ano de publicação:
2020
Tipo de documento:
Article