کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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1966026 | 1538709 | 2010 | 4 صفحه PDF | دانلود رایگان |
![عکس صفحه اول مقاله: Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes Traceability to a common standard for protein measurements by immunoassay for in-vitro diagnostic purposes](/preview/png/1966026.png)
BackgroundThere 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.MethodsWe 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.ResultsThe 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.ConclusionsThe 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.
Journal: Clinica Chimica Acta - Volume 411, Issues 23–24, 14 December 2010, Pages 2058–2061