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      Effect of storage temperature and time on measurement of serum symmetric dimethylarginine concentration using point‐of‐care and commercial laboratory analyzers in cats and dogs

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          Abstract

          Background

          Stability of serum symmetric dimethylarginine (sSDMA) during short‐ and long‐term storage has not been assessed for the immunoassay of the Point‐of‐Care IDEXX Catalyst DX (POC) analyzer and the Enzyme Multiplied Immunoassay Technique of IDEXX commercial laboratory (CL). Also, the agreement between both analyzers is questioned.

          Objectives

          To determine (a) the effect of storage time and temperature on sSDMA measured by POC and CL; (b) the agreement between sSDMA measured by POC and CL; and (c) the imprecision of the POC.

          Animals

          Serum of cats (n = 17) and dogs (n = 18) with a range of SDMA concentrations (6 to >100 μg/dL).

          Methods

          Based on an equivalence trial with predefined equivalence range (−3.0 to +3.0 μg/dL) and using T0 as baseline, stability was evaluated after 24 hours at 22°C and 4°C (POC); after 7 days at 4°C (POC and CL) and after 10 and 24 months at −24°C and −80°C (CL). Bland‐Altman plots enabled method comparison. Imprecision of the POC was assessed by duplicate sSDMA measurements at T0.

          Results

          The POC analyzer produced equivalent sSDMA measurements if samples were stored for 24 hours at 4°C (95% confidence interval [CI]: −2.5‐2.0 μg/dL), but not when stored for 24 hours at room temperature (RT; 95% CI: −4.1 to 0.5 μg/dL) or after 7 days at 4°C (95% CI: −3.6‐1.0 μg/dL). The CL analyzer was less affected by preanalytical variation with clinically similar results obtained when samples were stored for 7 days at 4°C (95% CI: −2.2 to 2.4 μg/dL) and for at least 24 months at −24°C (95% CI: −1.7 to 2.9 μg/dL) and −80°C (95% CI: −1.5 to 3 μg/dL). A relevant mean difference of −2.3 μg/dL between both analyzers was found. Duplicate POC measurements were equivalent (95% CI: −2.6 to 2.0 μg/dL).

          Conclusions

          Delayed analysis may significantly change sSDMA depending on storage and measurement conditions. Interchangeable use of assays should be done with caution because analytical variation could be interpreted as clinically relevant change.

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          Most cited references38

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          Understanding Bland Altman analysis

          In a contemporary clinical laboratory it is very common to have to assess the agreement between two quantitative methods of measurement. The correct statistical approach to assess this degree of agreement is not obvious. Correlation and regression studies are frequently proposed. However, correlation studies the relationship between one variable and another, not the differences, and it is not recommended as a method for assessing the comparability between methods.
In 1983 Altman and Bland (B&A) proposed an alternative analysis, based on the quantification of the agreement between two quantitative measurements by studying the mean difference and constructing limits of agreement.
The B&A plot analysis is a simple way to evaluate a bias between the mean differences, and to estimate an agreement interval, within which 95% of the differences of the second method, compared to the first one, fall. Data can be analyzed both as unit differences plot and as percentage differences plot.
The B&A plot method only defines the intervals of agreements, it does not say whether those limits are acceptable or not. Acceptable limits must be defined a priori, based on clinical necessity, biological considerations or other goals.
The aim of this article is to provide guidance on the use and interpretation of Bland Altman analysis in method comparison studies.
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            Understanding equivalence and noninferiority testing.

            Increasingly, the goal of many studies is to determine if new therapies have equivalent or noninferior efficacies to the ones currently in use. These studies are called equivalence/noninferiority studies, and the statistical methods for their analysis require only simple modifications to the traditional hypotheses testing framework. Nevertheless, important and subtle issues arise with the application of such methods. This article describes the concepts and statistical methods involved in testing equivalence/noninferiority. The aim is to enable the clinician to understand and critically assess the growing number of articles utilizing such methods.
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              Correlation, agreement, and Bland-Altman analysis: statistical analysis of method comparison studies.

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                Author and article information

                Contributors
                dominique.paepe@ugent.be
                Journal
                J Vet Intern Med
                J Vet Intern Med
                10.1111/(ISSN)1939-1676
                JVIM
                Journal of Veterinary Internal Medicine
                John Wiley & Sons, Inc. (Hoboken, USA )
                0891-6640
                1939-1676
                11 August 2023
                Sep-Oct 2023
                : 37
                : 5 ( doiID: 10.1111/jvim.v37.5 )
                : 1794-1805
                Affiliations
                [ 1 ] Small Animal Department, Faculty of Veterinary Medicine Ghent University Ghent Belgium
                [ 2 ] Department of Morphology, Imaging, Orthopedics, Rehabilitation, and Nutrition Ghent University Ghent Belgium
                Author notes
                [*] [* ] Correspondence

                Dominique Paepe, Small Animal Department, Faculty of Veterinary Medicine, Ghent University, Salisburylaan 133, B9820 Merelbeke, Ghent, Belgium.

                Email: dominique.paepe@ 123456ugent.be

                Author information
                https://orcid.org/0000-0003-1183-2892
                https://orcid.org/0000-0002-1884-9366
                https://orcid.org/0000-0003-2093-2561
                https://orcid.org/0000-0001-6733-7925
                https://orcid.org/0000-0003-2919-1712
                Article
                JVIM16811
                10.1111/jvim.16811
                10472997
                37565515
                d086d9ef-ad14-4188-9635-a897373ba3d0
                © 2023 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals LLC on behalf of American College of Veterinary Internal Medicine.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

                History
                : 13 October 2022
                : 03 July 2023
                Page count
                Figures: 4, Tables: 3, Pages: 12, Words: 8423
                Categories
                Standard Article
                SMALL ANIMAL
                Standard Articles
                Nephrology/Urology
                Custom metadata
                2.0
                September/October 2023
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.3 mode:remove_FC converted:01.09.2023

                Veterinary medicine
                bias,clinical equivalence,imprecision,method comparison,stability,temperature,time
                Veterinary medicine
                bias, clinical equivalence, imprecision, method comparison, stability, temperature, time

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