Huth Stacey P, Relford Roberta, Steiner Jörg M, Strong-Townsend Marilyn I, Williams David A
IDEXX Laboratories Inc., One IDEXX Drive, Westbrook, ME 04096, USA.
Vet Clin Pathol. 2010 Sep;39(3):346-53. doi: 10.1111/j.1939-165X.2010.00245.x. Epub 2010 Aug 2.
The diagnosis of canine pancreatitis is challenging. Clinical presentation often includes nonspecific clinical signs, such as vomiting, anorexia, and abdominal discomfort. Increased serum lipase activity can be indicative of pancreatitis; however, it can also be increased with other conditions. An immunoassay for measurement of canine pancreas-specific lipase in canine serum that would be suitable for commercial application and provide rapid results would be beneficial.
The goal of this study was to validate the Spec cPL assay, a commercially available ELISA for the quantitative measurement of canine pancreas-specific lipase.
Dynamic range, dilutional linearity, precision, interfering substances, assay stability, and reproducibility were investigated for analytical validation. The method was compared with the reference assay, canine pancreatic lipase immunoreactivity (cPLI), and included evaluation of a sample population of dogs and bias.
Analytical validation showed a dynamic range of 36-954 μg/L; good precision (intra- and interassay coefficient of variation <12%); absence of interference from lipid, hemoglobin, or bilirubin; 12-month kit stability; and good reproducibility. Method comparison showed a positive bias relative to the cPLI reference method; however, the bias can be accommodated by adjustment of decision limits. The upper limit of the reference interval for Spec cPL was determined to be 216 μg/L based on the upper 97.5th percentile of results from 93 clinically healthy, kennel-housed dogs.
Validation data demonstrated that the Spec cPL assay provides reproducible results for canine pancreas-specific lipase. A readily available assay for measurement of this enzyme allows broader clinical utilization of this analytical tool, generating timely results to aid in the diagnosis of canine pancreatitis.
犬胰腺炎的诊断具有挑战性。临床表现通常包括非特异性临床症状，如呕吐、厌食和腹部不适。血清脂肪酶活性升高可能提示胰腺炎；然而，在其他情况下也可能升高。一种用于测量犬血清中犬胰腺特异性脂肪酶的免疫测定法，若适用于商业应用并能提供快速结果将是有益的。
本研究的目的是验证Spec cPL测定法，一种用于定量测量犬胰腺特异性脂肪酶的市售酶联免疫吸附测定法。
对动态范围、稀释线性、精密度、干扰物质、测定稳定性和重现性进行研究以进行分析验证。将该方法与参考测定法犬胰腺脂肪酶免疫反应性（cPLI）进行比较，并对犬样本群体进行评估和偏差分析。
分析验证显示动态范围为36 - 954μg/L；精密度良好（批内和批间变异系数<12%）；不受脂质、血红蛋白或胆红素干扰；试剂盒稳定性为12个月；重现性良好。方法比较显示相对于cPLI参考方法存在正偏差；然而，通过调整判定限可以适应该偏差。根据93只临床健康、饲养在犬舍中的犬的结果的第97.5百分位数，确定Spec cPL参考区间的上限为216μg/L。
验证数据表明Spec cPL测定法可为犬胰腺特异性脂肪酶提供可重现的结果。一种易于获得的该酶测量方法可使这种分析工具在临床上得到更广泛的应用，产生及时的结果以辅助犬胰腺炎的诊断。
