Using Sigma metrics to establish analytical product performance requirements and
optimize analytical performance of an in vitro diagnostic assay using a
theoretical total PSA assay as an example
#MMPMID30022889
Petrides V
; Schneider S
Biochem Med (Zagreb)
2018[Jun]; 28
(2
): 020903
PMID30022889
show ga
INTRODUCTION: Establishing analytical performance requirements for in vitro
diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize
analytical performance by choosing amongst many combinations of different product
performance characteristics. Sigma metrics and method decision charts can be
helpful aids in choosing appropriate analytical performance requirements. The
objective of this research was to demonstrate the use of Sigma metrics and method
decision charts to help establish analytical performance requirements and to
optimize analytical performance at medical decision concentrations for an IVD
assay. MATERIALS AND METHODS: A range of possible Sigma metrics were determined
using three sources for total allowable error (TEa) and hypothetical total PSA
assay results. Method decision charts were created for each TEa source and used
to identify the maximum precision and bias that the assay could have to maintain
sigma level performance of at least 3. RESULTS: To achieve a sigma performance
level of at least 3 for a hypothetical total PSA assay, the maximum allowable
coefficient of variation ranged from 5.0% to 11.2% depending on the TEa source.
To achieve a sigma performance level of at least 6, the maximum allowable
coefficient of variation ranged from 2.5% to 5.6% depending on the TEa source.
CONCLUSIONS: Using Sigma metrics and method decision charts when establishing
analytical performance requirements can help manufacturers choose product
requirements that will optimize IVD assay product performance.
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