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- Title
Analysis of a 6-year pilot external quality assurance survey of free light chain using Sigma metrics.
- Authors
Chae, Hyojin; Yoo, Jaeeun; Park, Joonhong; Cha, Kyoungho; Lee, Jeong Joong; Cho, Bongrae; Kim, Myungshin; Kim, Yonggoo
- Abstract
Background: A pilot external quality assurance (EQA) survey for the free light chain (FLC) assay was developed and implemented in Korea. Methods: Survey data over 6 years (2010–2015) were collected retrospectively and Sigma metrics were calculated for method-specific peer groups. Results: Nineteen to 29 laboratories participated in the EQA survey, and nephelometric (20%) and turbidimetric (80%) methods were used. Using a previously published clinically relevant reference change value (RCV) of 54.5% as the tolerance limit, the method-specific median Sigma metrics of kappa (κ) and lambda (λ) FLC achieved greater than Three-Sigma for 86–97% of all EQA distributions, and Five-Sigma for 48–72% of all distributions. Conclusions: This EQA analysis of FLC assay applied clinically relevant quality specifications using Sigma metrics. During the 6-year EQA survey, we found that most of the results from participating laboratories meet clinically relevant quality specifications. In addition, method-specific differences were noted for λ FLC, at FLC concentrations above the initial measuring range that require a sample dilution.
- Subjects
SOUTH Korea; IMMUNOASSAY; IMMUNOGLOBULINS; PATHOLOGICAL laboratories; PHOTOMETRY; QUALITY assurance; REFERENCE values; SURVEYS; PILOT projects; AFFINITY groups; PEERS; RETROSPECTIVE studies
- Publication
Journal of Laboratory Medicine, 2019, Vol 43, Issue 5, p235
- ISSN
2567-9430
- Publication type
Article
- DOI
10.1515/labmed-2018-0175