Abstract
BackgroundA canine-specific immunoturbidimetric CRP assay, Gentian Canine CRP Immunoassay) with species-specific controls and calibrators was introduced and recently evaluated on the clinical chemistry analyzer Abbott Architect c4000 as well as on the Olympus AU600.Aims of our study were 1) to independently evaluate the canine-specific CRP assay on the ABX Pentra 400 clinical chemistry analyzer in comparison to the previously validated human-based immunoturbidimetric assay (Randox Canine CRP assay) and 2) to assess the impact of different sample types (serum versus heparinized plasma) on the results.Imprecision, accuracy, interference and the prozone effect were determined using samples from healthy and diseased dogs (n = 278). The Randox Canine CRP assay calibrated with canine specific control calibration material served as a reference method. Additionally, the impact of the sample type (serum and lithium heparin) was evaluated based on samples of healthy and diseased dogs (n = 49) in a second part of the study.ResultsLinearity was present for CRP concentrations ranging from 4 to 281 mg/l. For clinically relevant CRP concentrations of 7–281 mg/l, recovery ranged between 90 and 105% and intra- and inter-assay CVs ranged between 0.68% - 12.12% and 0.88% - 7.84%, respectively. CV was thus lower than 12.16%, i.e. the desired CV% based on biological variation. Interference was not present up to a concentration of 5 g/l hemoglobin, 800 mg/l bilirubin and 10 g/l triglycerides. No prozone effect occurred up to 676 mg/l CRP. Method comparison study revealed a Spearman’s rank correlation coefficient of rs = 0.98 and a mean constant bias of 5.2%. The sample type had a significant (P = 0.008) but clinically not relevant impact on the results (median CRP of 30.9 mg/l in lithium heparin plasma versus 31.4 mg/l in serum).ConclusionsThe species-specific Gentian Canine CRP Immunoassay reliably detects canine CRP on the ABX Pentra 400 clinical chemistry analyzer whereby both serum and heparin plasma can be used. The quality criteria reached on the Abbott Architect c4000 and Olympus AU600 could be met.
Highlights
A canine-specific immunoturbidimetric C-reactive protein (CRP) assay, Gentian Canine CRP Immunoassay) with speciesspecific controls and calibrators was introduced and recently evaluated on the clinical chemistry analyzer Abbott Architect c4000 as well as on the Olympus AU600
Measurement of C-reactive protein Both the Gentian Canine CRP Immunoassay and the Randox Canine CRP assay were run on the ABX Pentra 400 clinical chemistry analyzer (Horiba ABX SAS, Montpellier, France)
For CRP concentrations of 2.5 mg/l, a coefficient of variation (CV) markedly exceeding the desired CV was noted, so that the LoQ was set above the lowest concentrations still fulfilling the quality specifications i.e., 3.8 mg/l (≈ 4 mg/l)
Summary
A canine-specific immunoturbidimetric CRP assay, Gentian Canine CRP Immunoassay) with speciesspecific controls and calibrators was introduced and recently evaluated on the clinical chemistry analyzer Abbott Architect c4000 as well as on the Olympus AU600. Aims of our study were 1) to independently evaluate the canine-specific CRP assay on the ABX Pentra 400 clinical chemistry analyzer in comparison to the previously validated human-based immunoturbidimetric assay (Randox Canine CRP assay) and 2) to assess the impact of different sample types (serum versus heparinized plasma) on the results. In contrast to classic inflammatory markers such as the white blood cell count, APPs react more rapidly and with a shorter half-life period [1, 5]. Minor APPs react with a mild 1.5- to 2-fold increase [3] Due to their marked, rapid increase, especially major APPs are sensitive diagnostic and prognostic measurands [6, 7] to monitor systemic inflammation. An increase of CRP was shown in several conditions including infectious diseases [8,9,10,11], immune mediated diseases [12,13,14], neoplasias [12, 15, 16], and surgery [17]
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