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Protein Standardization IV: Value Transfer. Procedure for the Assignment of Serum Protein Values from a Reference Preparation to a Target Material

  • Søren Blirup-Jensen , A. Myron Johnson and Marianne Larsen
Published/Copyright: June 1, 2005
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Volume 39 Issue 11

Abstract

A new approach for the assignment of values to serum proteins in a target material using a reference preparation has been developed. The procedure describes the general as well as the practical principles involved in the value assignment (with examples). Two models have been developed: 1) The direct value transfer between serum matrices and 2) the indirect value transfer from a pure protein preparation to a serum protein material. The necessary mathematical equations are developed and explained. The data reduction and statistical evaluation are discussed. The practical procedure (the transfer protocol) is based on six dilutions of the reference preparation assayed together with six dilutions of the target material. In this way imprecision is reduced and the proportionality of the two materials (i.e. the presence or absence of matrix effects) can be assessed directly by evaluating a single regression plot. If no matrix effects are found, the regression line will pass through zero with a slope equal to the ratio of the concentrations of the two materials. The transfer protocol is based on a multiple point value assignment obtained by several measurements a day repeated on several days, an important prerequisite being that all reconstitutions and dilutions are controlled by weighing.

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Published Online: 2005-06-01
Published in Print: 2001-11-26

Copyright © 2001 by Walter de Gruyter GmbH & Co. KG

Articles in the same Issue

  1. The Present State of Protein Analysis and Interpretation
  2. In Memoriam Carl-Bertil Laurell
  3. From Paper Electrophoresis to Computer-supported Interpretation of Capillary Electrophoresis – Clinical Plasma Protein Analysis in Malmö, Sweden
  4. The Pavia Approach to Clinical Protein Analysis
  5. How the Foundation for Blood Research (FBR) Has Managed Serum Protein Testing for New England Clinicians
  6. Evidence-Based Laboratory Interpretation System Built on a Large Collection of Case Records with Well-Defined Diagnoses
  7. A Knowledge-Based System to Aid with the Clinical Interpretation of Complex Serum Protein Data
  8. Markers of the Acute Phase Response in Cardiovascular Disease: An Update
  9. Protein Aggregation
  10. Protein Standardization I: Protein Purification. Procedure for the Purification of Human Prealbumin, Orosomucoid and Transferrin as Primary Protein Preparations
  11. Protein Standardization II: Dry Mass Determination. Procedure for the Determination of the Dry Mass of a Pure Protein Preparation
  12. Protein Standardization III: Method Optimization. Basic Principles for Quantitative Determination of Human Serum Proteins on Automated Instruments Based on Turbidimetry or Nephelometry
  13. Protein Standardization IV: Value Transfer. Procedure for the Assignment of Serum Protein Values from a Reference Preparation to a Target Material
  14. Effect of Certified Reference Material 470 (CRM 470) on National Quality Assurance Programs for Serum Proteins in Europe
  15. Commutability of Serum Protein Values: Persisting Bias among Manufacturers Using Values Assigned from the Certified Reference Material 470 (CRM 470) in the United States
  16. The Existing Interim Consensus Reference Ranges and the Future Approach
  17. Using Multiples of the Median to Normalize Serum Protein Measurements
  18. Strategy for Determining Racial and Environmental Similarities and Differences for Plasma Proteins
  19. Standardization of Immunoassay for CRM-Related Proteins in Japan: From Evaluating CRM 470 to Setting Reference Intervals
  20. Soluble Transferrin Receptor (sTfR): Biological Variations and Reference Limits
  21. High Sensitivity C-Reactive Protein (CRP) Reference Intervals in the Elderly
  22. High Sensitivity Immunoassays for C-Reactive Protein: Promises and Pitfalls
  23. Meetings and Awards
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