Open AccessLEGO Plot for Simultaneous Application of Multiple Quality Requirements During Trueness Verification of Quantitative Laboratory Tests
Author(s) -
Park Haeil,
Chae Hyojin,
Kim Myungshin,
Lee Jehoon,
Kim Yonggoo
Publication year - 2014
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.21659
Subject(s) - header , certified reference materials , statistics , mathematics , confidence interval , plot (graphics) , quality (philosophy) , external quality assessment , chromatography , analytical chemistry (journal) , chemistry , engineering , detection limit , operations management , physics , quantum mechanics
Background We developed a two‐dimensional plot for viewing trueness that takes into account potential shift and variable quality requirements to verify trueness using certified reference material (CRM). Methods Glucose, total cholesterol (TC), and creatinine levels were determined by two kinds of assay in two levels of a CRM. Available quality requirements were collected, codified, and sorted in an ascending order in the plot's header row. Centering on the mean of measured values from CRM, the “mean ± US CLIA '88 allowable total error” was located in the header of the leftmost and rightmost columns. Twenty points were created in intervening columns as potential shifts. Uncertainties were calculated according to regression between certified values and uncertainties of CRM, and positioned in the corresponding columns. Cells were assigned different colors where column and row intersected based on comparison of the 95% confidence interval of the percentage bias with each quality requirement. Results A glucose assay failed to meet the highest quality criteria, for which shift of +0.13–0.14 mmol/l was required. A TC assay met the quality requirement and a shift of ±0.03 mmol/l was tolerable. A creatinine assay also met the quality requirement but any shift was not tolerable. Conclusion The plot provides a systematic view of the trueness of quantitative laboratory tests.