Standardization of Immunoassay for CRM-Related Proteins in Japan: From Evaluating CRM 470 to Setting Reference Intervals
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Abstract
The Japan National Institute of Health (JNIH), in close collaboration with academic societies, commercial companies, and the Japan Society of Medical Technologists, has led in the attempt to standardize plasma protein assays since the mid 1980s. Under a framework of global standardization, they used WHO primary reference materials to reduce discrepancies in values reported for proteins assayed using different systems, thus laying the foundations for a protein immunoassay standardization system in Japan. With the introduction of CRM 470 in 1993, the Japanese Committee for Clinical Laboratory Standards (JCCLS) has taken the initiative in promoting the use of the new material and bringing about the re-evaluation of all systems of quality assurance in clinical laboratories. This eventually led to the establishment of reference intervals in Japanese populations of children and adults after preparation of assigned calibrators from CRM 470 for each assay system. Here we review the history of a series of projects carried out in Japan and describe several remaining problems, through which we will attempt to evaluate the potential value of protein immunoassay standardization.
Copyright (c) 2001 by Walter de Gruyter GmbH & Co. KG
Artikel in diesem Heft
- The Present State of Protein Analysis and Interpretation
- In Memoriam Carl-Bertil Laurell
- From Paper Electrophoresis to Computer-supported Interpretation of Capillary Electrophoresis – Clinical Plasma Protein Analysis in Malmö, Sweden
- The Pavia Approach to Clinical Protein Analysis
- How the Foundation for Blood Research (FBR) Has Managed Serum Protein Testing for New England Clinicians
- Evidence-Based Laboratory Interpretation System Built on a Large Collection of Case Records with Well-Defined Diagnoses
- A Knowledge-Based System to Aid with the Clinical Interpretation of Complex Serum Protein Data
- Markers of the Acute Phase Response in Cardiovascular Disease: An Update
- Protein Aggregation
- Protein Standardization I: Protein Purification. Procedure for the Purification of Human Prealbumin, Orosomucoid and Transferrin as Primary Protein Preparations
- Protein Standardization II: Dry Mass Determination. Procedure for the Determination of the Dry Mass of a Pure Protein Preparation
- Protein Standardization III: Method Optimization. Basic Principles for Quantitative Determination of Human Serum Proteins on Automated Instruments Based on Turbidimetry or Nephelometry
- Protein Standardization IV: Value Transfer. Procedure for the Assignment of Serum Protein Values from a Reference Preparation to a Target Material
- Effect of Certified Reference Material 470 (CRM 470) on National Quality Assurance Programs for Serum Proteins in Europe
- Commutability of Serum Protein Values: Persisting Bias among Manufacturers Using Values Assigned from the Certified Reference Material 470 (CRM 470) in the United States
- The Existing Interim Consensus Reference Ranges and the Future Approach
- Using Multiples of the Median to Normalize Serum Protein Measurements
- Strategy for Determining Racial and Environmental Similarities and Differences for Plasma Proteins
- Standardization of Immunoassay for CRM-Related Proteins in Japan: From Evaluating CRM 470 to Setting Reference Intervals
- Soluble Transferrin Receptor (sTfR): Biological Variations and Reference Limits
- High Sensitivity C-Reactive Protein (CRP) Reference Intervals in the Elderly
- High Sensitivity Immunoassays for C-Reactive Protein: Promises and Pitfalls
- Meetings and Awards
Artikel in diesem Heft
- The Present State of Protein Analysis and Interpretation
- In Memoriam Carl-Bertil Laurell
- From Paper Electrophoresis to Computer-supported Interpretation of Capillary Electrophoresis – Clinical Plasma Protein Analysis in Malmö, Sweden
- The Pavia Approach to Clinical Protein Analysis
- How the Foundation for Blood Research (FBR) Has Managed Serum Protein Testing for New England Clinicians
- Evidence-Based Laboratory Interpretation System Built on a Large Collection of Case Records with Well-Defined Diagnoses
- A Knowledge-Based System to Aid with the Clinical Interpretation of Complex Serum Protein Data
- Markers of the Acute Phase Response in Cardiovascular Disease: An Update
- Protein Aggregation
- Protein Standardization I: Protein Purification. Procedure for the Purification of Human Prealbumin, Orosomucoid and Transferrin as Primary Protein Preparations
- Protein Standardization II: Dry Mass Determination. Procedure for the Determination of the Dry Mass of a Pure Protein Preparation
- Protein Standardization III: Method Optimization. Basic Principles for Quantitative Determination of Human Serum Proteins on Automated Instruments Based on Turbidimetry or Nephelometry
- Protein Standardization IV: Value Transfer. Procedure for the Assignment of Serum Protein Values from a Reference Preparation to a Target Material
- Effect of Certified Reference Material 470 (CRM 470) on National Quality Assurance Programs for Serum Proteins in Europe
- Commutability of Serum Protein Values: Persisting Bias among Manufacturers Using Values Assigned from the Certified Reference Material 470 (CRM 470) in the United States
- The Existing Interim Consensus Reference Ranges and the Future Approach
- Using Multiples of the Median to Normalize Serum Protein Measurements
- Strategy for Determining Racial and Environmental Similarities and Differences for Plasma Proteins
- Standardization of Immunoassay for CRM-Related Proteins in Japan: From Evaluating CRM 470 to Setting Reference Intervals
- Soluble Transferrin Receptor (sTfR): Biological Variations and Reference Limits
- High Sensitivity C-Reactive Protein (CRP) Reference Intervals in the Elderly
- High Sensitivity Immunoassays for C-Reactive Protein: Promises and Pitfalls
- Meetings and Awards
