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Analytical performance and method comparison of a quantitative point-of-care immunoassay for measurement of bile acids in cats and dogs
The Journal of Veterinary Diagnostic Investigation ( IF 1.2 ) Pub Date : 2020-10-28 , DOI: 10.1177/1040638720968784
Kristina Weiler 1 , Katharina Kleber 1 , Sabine Zielinsky 1 , Andreas Moritz 1 , Natali Bauer 1
Affiliation  

Point-of-care analyzers (POCAs) for quantitative assessment of bile acids (BAs) are scarce in veterinary medicine. We evaluated the Fuji Dri-Chem Immuno AU10V analyzer and v-BA test kit (Fujifilm) for detection of feline and canine total serum BA concentration. Results were compared with a 5th-generation assay as reference method and a 3rd-generation assay, both run on a bench-top analyzer. Analytical performance was assessed at 3 different concentration ranges, and with interferences. For method comparison, samples of 60 healthy and diseased cats and 64 dogs were included. Linearity was demonstrated for a BA concentration up to 130 µmol/L in cats (r = 0.99) and 110 µmol/L in dogs (r = 0.99). The analyzer showed high precision near the lower limit of quantification of 2 µmol/L reported by the manufacturer. Intra- and inter-assay coefficients of variation were < 5% for both species and all concentrations. Interferences were observed for bilirubin (800 mg/L) and lipid (4 g/L). There was excellent correlation with the reference method for feline (rs = 0.98) and canine samples (rs = 0.97), with proportional biases of 6.7% and −1.3%, respectively. However, a large bias (44.1%) was noted when the POCA was compared to the 3rd-generation assay. Total observed error was less than total allowable error at the 3 concentrations. The POCA reliably detected feline and canine BA in clinically relevant concentrations.



中文翻译:


用于测量猫和狗胆汁酸的定量护理点免疫测定的分析性能和方法比较



用于定量评估胆汁酸 (BA) 的即时分析仪 (POCA) 在兽医学中很少见。我们评估了 Fuji Dri-Chem 免疫 AU10V 分析仪和 v-BA 检测试剂盒(Fujifilm)用于检测猫科动物和犬科动物血清总 BA 浓度。将结果与作为参考方法的第五代测定和第三代测定进行比较,两者均在台式分析仪上运行。在 3 个不同的浓度范围和干扰情况下评估分析性能。为了进行方法比较,纳入了 60 只健康和患病的猫以及 64 只狗的样本。猫中 BA 浓度高达 130 µmol/L ( r = 0.99) 和狗中 BA 浓度高达 110 µmol/L ( r = 0.99) 时均表现出线性。该分析仪显示出接近制造商报告的 2 µmol/L 定量下限的高精度。两个物种和所有浓度的测定内和测定间变异系数均< 5%。观察到胆红素 (800 mg/L) 和脂质 (4 g/L) 的干扰。猫科动物 ( rs = 0.98) 和犬科动物样本 ( rs = 0.97) 与参考方法具有极好的相关性,比例偏差分别为 6.7% 和 -1.3%。然而,当 POCA 与第三代检测进行比较时,发现存在较大偏差 (44.1%)。 3 个浓度下的总观察误差小于总允许误差。 POCA 可靠地检测出临床相关浓度的猫科动物和犬科动物 BA。

更新日期:2020-10-29
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