Merck & Co., Inc., Clinical Development Laboratory, RY 50-100, 126 East Lincoln Avenue, Rahway, NJ 07065, United States.
J Immunol Methods. 2013 Apr 30;390(1-2):30-4. doi: 10.1016/j.jim.2013.01.002. Epub 2013 Jan 10.
Interleukin-22 (IL-22) is a key mediator of inflammatory processes associated with diseases such as psoriasis, inflammatory bowel disease and rheumatoid arthritis. The measurement of this cytokine in human plasma may provide insight into safety, pharmacodynamics and efficacy of drugs targeting inflammatory pathways. However, commonly used immunoassays are not sufficiently sensitive to measure baseline concentrations of IL-22. Here we describe the analytical validation of an ultrasensitive assay for the measurement of IL-22 in human serum using the Erenna® system by Singulex (Alameda, CA). The lower limit of quantification (LLOQ) of the Erenna assay estimated at 0.2pg/mL was sensitive enough to measure IL-22 in all human serum samples tested. The assay ranged from 0.2 to 100.0pg/mL and showed good dilution linearity. The inter-assay and intra-assay imprecision were <9% and <7% CV respectively. The accuracy determined by spiked recovery in serum samples was >86%. In addition, the results using Erenna assay correlated well with those using the IL-22 Quantikine immunoassay (R&D Systems, Minneapolis, MN) with a coefficient R(2) of 0.9285. However the Erenna assay showed an improved sensitivity by approximately 2 logs. These results show that this novel assay offers a significant improvement over previous methods for high-sensitive quantitative measurement of IL-22 in human serum samples.
白细胞介素-22 (IL-22) 是与银屑病、炎症性肠病和类风湿关节炎等疾病相关的炎症过程的关键介质。该细胞因子在人血浆中的测量可能有助于了解靶向炎症途径的药物的安全性、药效学和疗效。然而，常用的免疫测定法不够灵敏，无法测量 IL-22 的基线浓度。在这里，我们描述了使用 Singulex（加利福尼亚州阿拉米达）的 Erenna®系统测量人血清中 IL-22 的超灵敏测定法的分析验证。Erenna 测定法的定量下限 (LLOQ) 估计为 0.2pg/mL，足够灵敏，可以测量所有测试的人血清样本中的 IL-22。该测定范围为 0.2 至 100.0pg/mL，显示出良好的稀释线性。批内和批间精密度分别<9%和<7%CV。通过在血清样本中添加回收物确定的准确性>86%。此外，Erenna 测定法的结果与使用 IL-22 Quantikine 免疫测定法（明尼苏达州明尼阿波利斯的 R&D Systems）的结果非常相关，相关系数 R(2)为 0.9285。然而，Erenna 测定法的灵敏度提高了约 2 个对数。这些结果表明，与以前用于人血清样本中 IL-22 的高灵敏度定量测量的方法相比，该新型测定法提供了显著的改进。
