Clinical biochemistry
-
Clinical biochemistry · Nov 2016
Practical application of biological variation and Sigma metrics quality models to evaluate 20 chemistry analytes on the Beckman Coulter AU680.
This study aimed to evaluate the imprecision and bias data generated for 20 routine chemistry analytes against both the biological variation fitness for purpose (FFP) and Sigma metrics (SM) criteria. ⋯ The individual interpretation of bias and imprecision using FFP criteria allowed for the clear determination of the major source of error. Whereas, SM provided a summative evaluation of method performance. But the selection of total allowable error (TEa) is fundamental to this interpretation and harmonisation of the TEa calculation is needed.