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Clin Chim Acta. 2010 Dec 14;411(23-24):2058-61. doi: 10.1016/j.cca.2010.09.001. Epub 2010 Sep 7.

Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes.

Author information

1
Laboratory for Analytical Chemistry, Faculty of Pharmaceutical Sciences, Gent University, Gent, Belgium. linda.thienpont@ugent.be

Abstract

BACKGROUND:

There is a lot of confusion about the meaning of "measuring a protein in biological fluids" for in-vitro diagnostic purposes. This is due to a lack of understanding of metrological concepts and of acceptance of a pragmatic metrological concept for mixture analysis.

METHODS:

We describe the metrological concepts that apply to measurement of proteins. We propose a pragmatic reference measurement system for protein analysis. We investigate the feasibility of the approach with TSH as example.

RESULTS:

The reference measurement system for a protein should be viewed as a dynamic continuum from discovery to translation into an SI-component. A quasi surrogate component-mixture may be defined by recommendations for epitopes that immunoassays should recognize. The all-procedure trimmed mean is proposed as surrogate reference measurement procedure. Traceability is established by transfer of the IU of an WHO standard to a panel of commutable sera. Investigation of the TSH-example showed that the approach may be feasible.

CONCLUSIONS:

The proposed pragmatic concept would be a major step towards traceability of protein measurements by immunoassay. It would allow a staged introduction of standardization during the continuum from discovery of a protein to full scientific understanding and transformation to the SI-unit.

PMID:
20831866
DOI:
10.1016/j.cca.2010.09.001
[Indexed for MEDLINE]

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