Department of Clinical Sciences, College of Veterinary Medicine, Mississippi State University, Mississippi State, Mississippi, USA.
Gastrointestinal Laboratory, Department of Small Animal Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Texas A&M University, College Station, Texas, USA.
J Vet Intern Med. 2020 May;34(3):1150-1156. doi: 10.1111/jvim.15763. Epub 2020 Apr 6.
Sensitivity and specificity for commercial and in-house pancreatic lipase immunoreactivity (cPLI) assays have been reported, but repeatability under routine clinical conditions is unknown.
To determine: Coefficient of variation (CV) between replicates of a commercial assay (Spec cPL) and 2 in-house assays (VetScan cPL, Vcheck cPL) under routine conditions. Effects of sample condition or personnel on results. Potential directional bias between assays.
Serum from 12 canine clinical patients.
Prospective study. Serum Spec cPL, VetScan cPL, and Vcheck cPL (6 aliquots each) were measured, and CVs were calculated, effects of sample condition and personnel were assessed using a linear mixed model, and direction of bias was assessed using least square mean cPLI concentration.
Mean %CVs for Spec cPL, VetScan cPL, and Vcheck cPL were 5.5, 17.0, and 23.7%. Three of 6 VetScan cPL samples and 5/9 Vcheck cPL samples had an unacceptably high %CV (>20%). Transportation (Spec cPL) and sample condition or personnel (VetScan cPL, Vcheck cPL) did not affect repeatability. Least square mean cPL was higher for Spec cPL (807.9 μg/L) than for VetScan cPL (558.5 μg/L) or Vcheck cPL (399.8 μg/L).
For clinical use, the commercial Spec cPL has the highest repeatability, and Vcheck cPL has significantly lower repeatability. Both in-house assays evaluated may provide discrepant categorical results ("pancreatitis" versus "equivocal" versus "not pancreatitis") for the same sample. In-house pancreatic lipase concentrations may be lower than those determined by the Spec cPL assay.
商业和内部胰脂肪酶免疫活性（cPLI）检测的敏感性和特异性已经有报道，但在常规临床条件下的可重复性尚不清楚。
确定：在常规条件下，商业检测（Spec cPL）和 2 种内部检测（VetScan cPL、Vcheck cPL）的重复检测的变异系数（CV）。样本条件或人员对结果的影响。检测之间潜在的方向性偏差。
12 例犬临床患者的血清。
前瞻性研究。测量血清 Spec cPL、VetScan cPL 和 Vcheck cPL（每个 6 个等分试样），并计算 CV，使用线性混合模型评估样本条件和人员的影响，使用最小二乘平均 cPLI 浓度评估偏差方向。
Spec cPL、VetScan cPL 和 Vcheck cPL 的平均%CV 分别为 5.5%、17.0%和 23.7%。3 个 VetScan cPL 样本和 5/9 个 Vcheck cPL 样本的%CV 过高（>20%）。运输（Spec cPL）和样本条件或人员（VetScan cPL、Vcheck cPL）不影响重复性。最小二乘平均 cPL 浓度，Spec cPL（807.9μg/L）高于 VetScan cPL（558.5μg/L）或 Vcheck cPL（399.8μg/L）。
对于临床使用，商业 Spec cPL 的重复性最高，Vcheck cPL 的重复性显著较低。评估的 2 种内部检测可能会为同一样本提供不一致的分类结果（“胰腺炎”与“不确定”与“非胰腺炎”）。内部胰脂肪酶浓度可能低于 Spec cPL 检测的结果。
