Evaluation of three automated human immunoturbidimetric assays for the detection of C-reactive protein in dogs

Abstract

C-reactive protein (CRP) is a major, acute-phase protein in dogs; however, there is a need for automated assays to ensure in-time patient monitoring. Three automated immunoturbidimetric assays (Randox, Thermo, and Wako) developed for human beings were evaluated for their ability to detect canine CRP, including method validation, evaluation of diagnostic use, and establishment of exploratory reference intervals. Sera from 36 healthy dogs and 82 diseased dogs were included for method comparison with the enzyme-linked immunosorbent assay (ELISA; Tridelta) serving as the reference method. A nonparametric estimate of the 1-sided 95% reference interval was established (n 5 36). Precision study revealed good intraassay coefficients of variation (CVs) of 1-10%, 0-9%, and 2-13% for the Randox, Thermo, and Wako assays, respectively. Interassay CVs were 18%, 24%, and 19% respectively. Because of a low linear range, the Thermo test was considered unsuitable for use with canine specimens. No significant differences were present between the results obtained with the Randox and Wako assays with CRP concentrations less than 15 mg/l; however, median CRP results differed significantly between the Thermo test and the ELISA (P 5 0.03). Bland-Altman analysis detected a proportional bias of 0.28, 20.59, and 0.61 mg/l for the Randox, Thermo, and Wako assays, respectively. For all tests, median CRP values were significantly different between healthy dogs and dogs with neoplasia. The upper limit of the reference intervals were 8.2 and 9.9 mg/l for the Randox and Wako assays, respectively. In contrast to the Thermo test, the Randox and Wako assays were suitable for detection of abnormally high canine CRP concentrations; however, improvement of assay precision and evaluation of accuracy are warranted before their clinical use with canine specimens.