Analytical performance of a dry chemistry analyzer designed for in-clinic use.
Abstract: 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. Objective: 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 13s control rule. Methods: Sixteen analytes were measured using plasma from dogs, cats, and horses. Coefficient of variation (CV), bias, and observed total error (TEobs ) were calculated. TEobs was compared with allowable total error (TEa ). Sigma metric and quality goal index were calculated where relevant. QC validation was performed. Results: Bias and TEobs calculated using quality control material (QCM) data were smaller than those calculated using method comparison data. Using TEobs calculated from species-specific CV and QCM-based bias, 100% of analytes in each species met ASVCP-recommended TEa . Desired error detection and false rejection rates were achievable using the 13s control rule and ASVCP-recommended TEa 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.
© 2014 American Society for Veterinary Clinical Pathology and European Society for Veterinary Clinical Pathology.
Publication Date: 2014-03-03 PubMed ID: 24588622DOI: 10.1111/vcp.12122Google Scholar: Lookup
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- Comparative Study
- Evaluation Study
- Journal Article
Summary
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This study evaluates the analytical performance of the Heska Dri-Chem 4000, a dry slide technology analyzer for serum or plasma, focusing on its precision and bias, and the possibility of implementing statistical quality control (QC) rules for improved accuracy.
Objective and Methods of the Study
- The objectives of the study were threefold: to measure precision and bias of the Dri-Chem 4000, to stack its performance against predetermined quality requirements, and explore the plausibility of using the 13s control rule for its statistical QC.
- Multiple tests were conducted as part of the study—analytes were measured using plasma from dogs, cats, and horses. Various mathematical properties such as the coefficient of variation (CV), bias, and total observed error (TEobs) were calculated from the results, which were then compared with the allowable total error (TEa). Other measurements included the sigma metric and quality goal index.
- The performance of 16 different analytes was evaluated, and quality control validation was performed.
Results Obtained
- In terms of bias and TEobs using quality control material (QCM) data, smaller values were observed compared to those derived from comparison data methods.
- The total observed error (TEobs), calculated using species-specific coefficients of variation and QCM-based bias, met the TEa values as recommended by the American Society for Veterinary Clinical Pathology (ASVCP), for 100% of the analysed substances in each species (dogs, cats, and horses).
- The 13s control rule and ASVCP-recommended TEa values were found to be effective in catching errors and minimizing false rejection rates for approximately 60% of the tested analytes for each of the three species.
Conclusions
- The study concludes that the analytical performance of the Dri-Chem 4000 aligns well with those of other benchtop biochemistry analyzers, as suggested by previous studies.
- Implementing the 13s control rule for statistical QC is possible for most tested substances in dogs, cats, and horses, thus enhancing the analyzer’s reliability.
Cite This Article
APA
Flatland B, Breickner LC, Fry MM.
(2014).
Analytical performance of a dry chemistry analyzer designed for in-clinic use.
Vet Clin Pathol, 43(2), 206-217.
https://doi.org/10.1111/vcp.12122 Publication
Researcher Affiliations
- Department of Biomedical and Diagnostic Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, TN, USA.
MeSH Terms
- Animals
- Blood Chemical Analysis / instrumentation
- Blood Chemical Analysis / standards
- Blood Chemical Analysis / veterinary
- Cats
- Diagnostic Errors / veterinary
- Dogs
- Horses
- Point-of-Care Systems / standards
- Quality Control
- Reproducibility of Results
- Species Specificity
Citations
This article has been cited 7 times.- Carlton C, Norris JM, Hall E, Ward MP, Blank S, Gilmore S, Dabydeen A, Tran V, Westman ME. Clinicopathological and Epidemiological Findings in Pet Cats Naturally Infected with Feline Immunodeficiency Virus (FIV) in Australia. Viruses 2022 Sep 30;14(10).
- Korchia J, Freeman KP. Total observed error, total allowable error, and QC rules for canine serum and urine cortisol achievable with the Immulite 2000 Xpi cortisol immunoassay. J Vet Diagn Invest 2022 Mar;34(2):246-257.
- Flatland B, Baral RM, Freeman KP. Current and emerging concepts in biological and analytical variation applied in clinical practice. J Vet Intern Med 2020 Nov;34(6):2691-2700.
- Sato T, Ohno K, Tamamoto T, Oishi M, Kanemoto H, Fukushima K, Goto-Koshino Y, Takahashi M, Tsujimoto H. Assessment of severity and changes in C-reactive protein concentration and various biomarkers in dogs with pancreatitis. J Vet Med Sci 2017 Jan 20;79(1):35-40.
- Reeve J, Warman S, Lewis D, Watson N, Papasouliotis K. Evaluation of a handheld point-of-care analyser for measurement of creatinine in cats. J Feline Med Surg 2017 Feb;19(2):207-215.
- Baral RM, Dhand NK, Morton JM, Krockenberger MB, Govendir M. Bias in feline plasma biochemistry results between three in-house analysers and a commercial laboratory analyser: results should not be directly compared. J Feline Med Surg 2015 Aug;17(8):653-66.
- Baral RM, Dhand NK, Krockenberger MB, Govendir M. Assessments of feline plasma biochemistry reference intervals for three in-house analysers and a commercial laboratory analyser. J Feline Med Surg 2015 Aug;17(8):667-79.
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