Department of Laboratory Medicine, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Ningbo Yinzhou NO.2 Hospital, Ningbo, China.
J Clin Lab Anal. 2021 Nov;35(11):e24051. doi: 10.1002/jcla.24051. Epub 2021 Oct 15.
Acute kidney injury (AKI) was a common clinical complication among critically ill patients in Intensive Care Unit with high morbidity and mortality. Human liver fatty acid-binding protein (L-FABP) as a renal tubular injury biomarker was considered a predictor of AKI; however, high-throughput and sensitive detection methods were still urgently needed. We constructed a sensitive and rapid detection method for detecting L-FABP and for exploring the clinical application of L-FABP as a predictor for AKI.
We developed an automated detection method of chemiluminescent immunoassay to measure L-FABP and evaluated the analytical performance of the new methodology including analytical selectivity, analytical sensitivity, linear range, the minimum limit of detection (LOD), repeatability, and accuracy. One hundred patients were enrolled in this study to explore the predictive and diagnostic ability for AKI.
The chemiluminescent immune-based L-FABP assay had outstanding analytical sensitivity including the detection limit of 0.88 ng/ml, and a wide linear range of 2 ng/ml to 160 ng/ml. It also exhibited excellent repeatability with intra-analysis CVs of 8.73%, 4.72%, and 3.79%, respectively, and the inter-analysis CVs of 13.47%, 7.28%, and 5.94%, respectively. The recovery rate assay exhibited a good accuracy with three L-FABP concentration of 99.76%, 102.27%, and 96.92%, respectively. The reference interval of L-FABP was between 0.88 ng/ml and 5.98 ng/ml. The evaluation of predictive and diagnostic performance showed that higher concentration of L-FABP indicated higher risk of AKI occurrence and disease progression.
The clinical application of rapid and sensitive detection method of L-FABP based on the newly developed chemiluminescent immunoassay could offer benefits for patients. L-FABP was a potentially predictive and diagnostic biomarker for AKI.
急性肾损伤（AKI）是重症监护病房中危重病患者常见的临床并发症，发病率和死亡率均较高。人肝型脂肪酸结合蛋白（L-FABP）作为一种肾小管损伤生物标志物，被认为是 AKI 的预测因子；然而，仍然迫切需要高通量和敏感的检测方法。我们构建了一种灵敏、快速的 L-FABP 检测方法，探讨了 L-FABP 作为 AKI 预测因子的临床应用。
我们开发了一种化学发光免疫测定的自动化检测方法来测量 L-FABP，并评估了新方法的分析性能，包括分析选择性、分析灵敏度、线性范围、最小检测限（LOD）、重复性和准确性。本研究共纳入 100 例患者，以探讨其对 AKI 的预测和诊断能力。
基于化学发光免疫的 L-FABP 检测方法具有出色的分析灵敏度，检测限为 0.88ng/ml，线性范围为 2ng/ml 至 160ng/ml。它还具有出色的重复性，日内 CV 分别为 8.73%、4.72%和 3.79%，日间 CV 分别为 13.47%、7.28%和 5.94%。回收率试验显示出良好的准确性，三个 L-FABP 浓度的回收率分别为 99.76%、102.27%和 96.92%。L-FABP 的参考区间为 0.88ng/ml 至 5.98ng/ml。预测和诊断性能的评估表明，L-FABP 浓度越高，AKI 发生和疾病进展的风险越高。
基于新开发的化学发光免疫法的 L-FABP 快速灵敏检测方法的临床应用可为患者带来益处。L-FABP 是 AKI 的潜在预测和诊断生物标志物。
