背景:猫胰腺炎的诊断可能具有挑战性。临床表现通常包括轻度,非特异性临床体征,比如呕吐,厌食症,和减肥。据报道,血清中猫胰脂肪酶免疫反应性(fPLI)浓度的测量对于诊断猫胰腺炎是敏感且特异的。然而,尚未公布用于测量fPLI浓度的广泛可用的商业测定的分析验证。
目的:我们旨在分析验证SpecfPL测定(IDEXX实验室,威斯布鲁克,ME),用于测量FPLI浓度的商业ELISA,并重新评估其诊断猫胰腺炎的参考区间和决策阈值。
方法:稀释线性,准确度,精度,并评估了干扰物质的效果。参考区间的上限是根据临床健康猫的第95百分位数(n=107)的结果计算的,计算出诊断胰腺炎的决策阈值,预期特异性为99%.
结果:分析验证显示良好的线性,准确度,和精度,以及没有脂血的干扰,溶血,或者黄疸.SpecfPL的参考区间的上限确定为4.4μg/L,根据所需的99%特异性,诊断胰腺炎的决策阈值(理论临界值)确定为8.8μg/L。
结论:SpecfPL测定在分析上是有效的,结果表明,8.8μg/L的决策阈值对于排除临床健康猫具有很高的诊断特异性。
BACKGROUND: The diagnosis of feline pancreatitis can be challenging. The clinical presentation often includes mild, nonspecific clinical signs, such as vomiting, anorexia, and weight loss. Measurement of feline pancreatic lipase immunoreactivity (
fPLI) concentration in serum has been reported to be sensitive and specific for a diagnosis of pancreatitis in cats. However, analytical validation for a widely available commercial assay for the measurement of
fPLI concentration has not been published.
OBJECTIVE: We aimed to analytically validate the Spec fPL assay (IDEXX Laboratories, Westbrook, ME), a commercial ELISA for the measurement of
fPLI concentration, and re-evaluate its reference interval and decision threshold for diagnosing pancreatitis in cats.
METHODS: Dilutional linearity, accuracy, precision, and the effect of interfering substances were assessed. The upper limit of the reference interval was calculated based on the 95th percentile of results from clinically healthy cats (n = 107), and a decision threshold for diagnosing pancreatitis was calculated with an expected specificity of 99%.
RESULTS: Analytical validation demonstrated good linearity, accuracy, and precision, as well as the absence of interference from lipemia, hemolysis, or icterus. The upper limit of the reference interval for Spec fPL was determined to be 4.4 μg/L, and the decision threshold (a theoretical cut-off) for diagnosing pancreatitis was determined to be 8.8 μg/L based on a desired specificity of 99%.
CONCLUSIONS: The Spec fPL assay is analytically valid, and results suggest that a decision threshold of 8.8 μg/L would have high diagnostic specificity for excluding clinically healthy cats.