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Analytical performance of a dry chemistry analyzer designed for in‐clinic use
Author(s) -
Flatland Bente,
Breickner Liesl C.,
Fry Michael M.
Publication year - 2014
Publication title -
veterinary clinical pathology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.537
H-Index - 51
eISSN - 1939-165X
pISSN - 0275-6382
DOI - 10.1111/vcp.12122
Subject(s) - analyte , coefficient of variation , analytical chemistry (journal) , spectrum analyzer , chemistry , statistics , chromatography , mathematics , computer science , telecommunications
Background The Heska Dri‐Chem 4000 uses dry slide technology to evaluate serum or plasma. No previous independent performance evaluation is published to the authors' knowledge. Objectives The objectives were to (1) characterize analytical performance of a Dri‐Chem 4000 by measuring precision and bias, (2) compare analytical performance of that Dri‐Chem 4000 unit with a predetermined quality requirement, and (3) determine whether statistical QC of the Dri‐Chem 4000 is possible using the 1 3s control rule. Methods Sixteen analytes were measured using plasma from dogs, cats, and horses. Coefficient of variation (CV), bias, and observed total error (TE obs ) were calculated. TE obs was compared with allowable total error (TE a ). Sigma metric and quality goal index were calculated where relevant. QC validation was performed. Results Bias and TE obs calculated using quality control material (QCM) data were smaller than those calculated using method comparison data. Using TE obs calculated from species‐specific CV and QCM‐based bias, 100% of analytes in each species met ASVCP‐recommended TE a . Desired error detection and false rejection rates were achievable using the 1 3s control rule and ASVCP‐recommended TE a values for 9/16 (56%) of analytes in dogs, 9/14 (64%) of analytes in cats, and 8/13 (62%) of analytes in horses. Conclusions Analytical performance of the Dri‐Chem 4000 is comparable to that reported by other authors for other small benchtop biochemistry analyzers. Statistical QC using a simple control rule is possible for most analytes in dogs, cats, and horses.