Sigma Metric Assessment of Assay Quality

James F. Pierson-Perry
Principal Key Expert
R&D, Assay Development
Siemens Healthcare Diagnostics


Across industries, the Six Sigma methodology is widely considered to be a standard for evaluating product and process performance. In the healthcare industry, variability in the quality of product and process performance can negatively impact patient care decisions. For laboratory professionals, this means assessing assay performance quality to ensure consistent, timely, and accurate communication of test results to clinicians—critical for clinical decision making for their patients. The sigma metric calculation is a tool that can be used in the clinical laboratory setting to facilitate understanding of the robustness of assays against clinical need. This webinar will discuss use of the sigma metric for assessing assay performance and quality, share specific examples of such evaluations, and illustrate common pitfalls in performing sigma calculations.

Learning Objectives:

  • Discover the sigma metric as a tool for assessing the quality of assay performance.
  • Understand the importance of using more than a single sigma metric to assess assay performance.
  • Understand the data components needed for sigma metric assessment studies of assays.
  • Learn how to make critical evaluations of sigma metric claims for assays.
Jim Pierson-Perry

Speaker Bio and Image:
Jim Pierson-Perry is a Principal Key Expert in the Assay Development group of Siemens Healthcare Diagnostics. He has worked in R&D of in vitro diagnostics products for over 37 years, developing assays and leading local and multinational teams that have commercialized over 55 products for multiple instrument systems. His interests include assessing new clinical markers and technologies, optimization and data analysis techniques, process and design validation, and improving the product development process. Jim is a member of the CLSI Consensus Council and the IFCC Scientific Division Executive Committee. He received the 2011 Louis J. Dunka, Jr. memorial service award from the AACC Industry Division and the 2013 CLSI award for Excellence in Consensus Management.

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