tailieunhanh - Báo cáo khoa học: L1–Protein Diagnostics, Protein Determination

External quality assessment schemes are evaluated by method-dependent consensus values or by method independent target values, determined with reference measurement procedures. The reference measurement procedures yield values having a high trueness and precision with a defined uncertainty of measure-ment. The great advantage of the reference measurement proce-dure is that the comparability of results in the different medical laboratories is promoted and improved intending in the same ref-erence interval for an analyte in all laboratories. . | Abstracts L1-Protein Diagnostics Protein Determination L1-001 Reference measurement procedures and external quality assessment schemes H. Reinauer1 and P. Kaiser1 1 INSTAND . Dusseldorf Germany 2Rerence Laboratories INSTAND . Dusseldorf Germany. E-mail instand@ External quality assessment schemes are evaluated by methoddependent consensus values or by method independent target values determined with reference measurement procedures. The reference measurement procedures yield values having a high trueness and precision with a defined uncertainty of measurement. The great advantage of the reference measurement procedure is that the comparability of results in the different medical laboratories is promoted and improved intending in the same reference interval for an analyte in all laboratories. At the same time the manufacturers are motivated to calibrate their analytical systems in such a way that the best comparability of values in the external quality assessment schemes is given. The European regulation in that field is the In-vitro-diagnostic medical device directive . This directive gives an additional role to the external quality assessment schemes that is the vigilance of the market. The vigilance procedure of the diagnostic market intends to regis-trate and inform the manufacturers and the competent authorities of any incidence in the diagnostic system. To perform this vigilance procedure in an appropriate way a European standard has been developed EN 14136 . The interaction between EQAS-organizers the manufacturers and the routine laboratories will improve the quality of measurements in the medical laboratories in favour of the patients. One typical reference method measurement procedure will be presented to determine the concentration of digoxin and digitoxin in EQA-samples. The reference measurement procedures have already proved their significance within epidemiological studies. L1-002 International standardization of protein measurement