4.2 Article

Comparison of serum and plasma SDMA measured with point-of-care and reference laboratory analysers: implications for interpretation of SDMA in cats

Journal

JOURNAL OF FELINE MEDICINE AND SURGERY
Volume 23, Issue 10, Pages 906-920

Publisher

SAGE PUBLICATIONS LTD
DOI: 10.1177/1098612X20983260

Keywords

Symmetric dimethylarginine; method comparison; sigma metrics; dispersion; quality goal; imprecision; bias; test interpretation

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SDMA reflects the GFR in humans, dogs, and cats. A veterinary immunoassay has been developed for commercial laboratories and point-of-care equipment. Results showed consistent bias between point-of-care and commercial laboratory analysers, with high numbers of results falling outside performance goals. The analyser-specific reference intervals are likely needed for accurate interpretation of SDMA concentration changes.
Objectives Symmetric dimethylarginine (SDMA) reflects the glomerular filtration rate (GFR) in people, dogs and cats. Initial assays used a liquid chromatography-mass spectroscopy (LC-MS) technique. A veterinary immunoassay has been developed for use in commercial laboratories and point-of-care (POC) laboratory equipment. This study sought to: determine POC and commercial laboratory (CL) SDMA assay imprecision; determine any bias of the POC assay compared with the CL assay; calculate observed total error of the POC assay and compare with analytical performance goals; and calculate dispersion and sigma metrics (sigma) for POC and CL SDMA methods. Methods Two separate studies were performed that assessed: (1) imprecision, determined by evaluation of pooled feline plasma or serum; and (2) bias, assessed by comparing pooled plasma and serum results, as well as paired analyses of clinical samples from a single venepuncture measured using both analysers. Results were assessed in relation to performance goals. Dispersion and sigma were calculated for both analysers. Results Bias between CL and POC analysers was consistent and high numbers of clinical results were outside performance goals across both studies. Imprecision was poor for both analysers for study 1 and improved to within quality goals for the CL analyser for study 2. Dispersion was at least 40%, meaning a measured result of 14 mu g/dl represents a range of possible results from 8 mu g/dl to 20 mu g/dl. Conclusions and relevance Clinicians should be careful ascribing medical significance to small changes in SDMA concentration, as these may reflect analytical and biological variability. Analyser-specific reference intervals are likely required.

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