Short communication, Note

https://doi.org/10.11613/BM.2018.020903

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

Victoria Petrides ; Abbott, Abbott Park, IL, USA
Sharon Schneider ; Abbott, Abbott Park, IL, USA

Abstract

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.

Keywords

total quality management; decision making; goals

Hrčak ID:

201534

URI

https://hrcak.srce.hr/201534

Publication date:

15.6.2018.

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