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

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.