Chindarkar Nandkishor S, Chawla Lakhmir S, Straseski Joely A, Jortani Saeed A, Uettwiller-Geiger Denise, Orr Robert R, Kellum John A, Fitzgerald Robert L
Department of Pathology, Center for Advanced Laboratory Medicine, University of California-San Diego Health Systems, San Diego, CA, United States.
Department of Anesthesiology and Critical Care Medicine, George Washington University Medical Center, Washington, DC, United States.
Clin Chim Acta. 2016 Jan 15;452:32-7. doi: 10.1016/j.cca.2015.10.029. Epub 2015 Nov 10.
Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) have demonstrated significantly improved diagnostic performance in assessing risk for acute kidney injury (AKI) compared with existing biomarkers. We present the findings of a multi-site trial to determine the reference intervals for these biomarkers in apparently healthy adults and those with stable chronic morbid conditions without AKI.
A urine specimen was collected from apparently healthy subjects (N=378) and subjects with at least one stable chronic morbidity (N=372). Specimens were kept frozen until analysis with the NephroCheck® Test (Astute Medical). The test is comprised of fluorescence immunoassays for IGFBP7 and TIMP-2 and is used with the Astute140® Meter which quantifies the concentration of each biomarker. The meter multiplies the concentrations of IGFBP7 and TIMP-2 and displays the result as a numerical value ([IGFBP7]∙[TIMP-2]) expressed in (ng/ml)(2)/1000 which is called the AKIRisk™ Score.
The reference intervals (inner 95%) for [IGFBP7]∙[TIMP-2] in all subjects (N=750), apparently healthy subjects, and subjects with stable chronic morbidities were 0.04-2.22, 0.04-2.25, and 0.05-2.20 (ng/ml)(2)/1000 respectively. There was no statistical difference between reference intervals for apparently healthy and chronic stable morbid cohorts (p=0.42).
Our investigation showed that urine [IGFBP7]∙[TIMP-2] values were not elevated in patients with stable chronic morbidities who did not have AKI.
与现有生物标志物相比，胰岛素样生长因子结合蛋白7（IGFBP7）和金属蛋白酶组织抑制剂-2（TIMP-2）在评估急性肾损伤（AKI）风险方面的诊断性能有显著提高。我们展示了一项多中心试验的结果，以确定这些生物标志物在表面健康的成年人以及无AKI的稳定慢性疾病患者中的参考区间。
从表面健康的受试者（N = 378）和至少有一种稳定慢性疾病的受试者（N = 372）中收集尿液样本。样本在分析前一直冷冻保存，使用NephroCheck®检测（Astute Medical公司）。该检测由针对IGFBP7和TIMP-2的荧光免疫测定组成，并与Astute140®检测仪一起使用，该检测仪可量化每种生物标志物的浓度。该检测仪将IGFBP7和TIMP-2的浓度相乘，并将结果显示为以（ng/ml）(2)/1000表示的数值（[IGFBP7]∙[TIMP-2]），这被称为AKIRisk™评分。
所有受试者（N = 750）、表面健康受试者以及患有稳定慢性疾病的受试者中，[IGFBP7]∙[TIMP-2]的参考区间（95%内）分别为0.04 - 2.22、0.04 - 2.25和0.05 - 2.20（ng/ml）(2)/1000。表面健康队列和慢性稳定疾病队列的参考区间之间无统计学差异（p = 0.42）。
我们的研究表明，在没有AKI的稳定慢性疾病患者中，尿液[IGFBP7]∙[TIMP-2]值并未升高。
