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

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 (σ) for POC and CL SDMA 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 σ were calculated for both analysers.

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 μg/dl represents a range of possible results from 8 μg/dl to 20 μg/dl.

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.