“Beyond uncertainty “ - one-way ANOVA applied to the measurement uncertainty estimation and to the precision measuring procedure verification


Authors: J. Ambrožová
Authors‘ workplace: Oddělení klinické biochemie Nemocnice Prachatice, a. s.
Published in: Klin. Biochem. Metab., 21 (42), 2013, No. 2, p. 97-102

Overview

Objective:
To demonstrate the practical use of the „one-way ANOVA“ technique for the expression of measurement uncertainty in laboratory medicine as well as to simplify the process of the user verification of performance for precision according, according to documents CLSI (Clinical and Laboratory Standards Institute), titled as C51-A Vol.32 No.4 „Expression of Uncertainty in Measurement Laboratory Medicine, Approved Guideline“, 2012 [1], next only the C51-A, and according to CLSI EP15-A2 Vol. 25 No.17 document titled as „User verification of Performance for Precision and trueness; Approved Guideline, Second Edition“ [2], hereinafter EP15-A2.

Results:
The application of both normative practices is demonstrated in the practical example use for the uncertainty method estimation on one concentration level of the urea molar concentration in the human serum (measurand), together with the simplified procedure of the user verification of the method performance for the precision. The verification experiment matches the document EP15-A2, i.e. one measurand level running in 3 replicates on each of the 5 days. The calculation of the measurement uncertainty and the intermediate precision is processed by analyzing components of the variability in the „one-way ANOVA“ technique.

Objective - Discussion:
to demonstrate the possibility of simplifying the verification process

Conclusion:
the evaluation using one-way ANOVA technique to estimate the method uncertainty and the user verification of the method performance for the precision as well

Keywords:
CLSI C51-A [1], CLSI EP15-A2 [2], measurement uncertainty, precision, one-way ANOVA.


Sources

1. CLSI C51-A, Expression of Measurement Uncertainty in Laboratory Medicine, Approved Guideline, Vol. 32 No. 4, 2012

2. CLSI EP15-A2, User Verification of Performance for Precision and Trueness; Approved Guideline, Second Edition, Vol. 25, No.17, 2006

3. Friedecký, B., Šprongl, L., Kratochvíla, J., Plzák, Z., Doporučení k provádění validace a verifikace analy-tických metod v klinických laboratořích, Klin. Biochem.Metab., 2011, roč. 19 (BCB40) č. 1, s. 36-43

4. CLSI EP07-A2, Interference Testing in Clinical Chemistry, Approved Guideline, Second Edition, 2005

5. CLSI EP09-A2-IR, Method Comparison and Bias Estimation Using patient Samples, Approved Guideline, Second Edition, 2010

6. GUM 1995 with Minor Corrections: Evaluation of measurement data - Guide to the Expression of Uncertainty in Measurement, JCGM 100:2008

Labels
Clinical biochemistry Nuclear medicine Nutritive therapist
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