Rapid and sensitive detection of L-FABP for prediction and diagnosis of acute kidney injury in critically ill patients by chemiluminescent immunoassay

化学发光免疫分析法快速灵敏地检测L-FABP以预测和诊断危重患者急性肾损伤

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作者:Tao Sun, Shufang Qu, Tiancha Huang, Ying Ping, Qinyan Lin, Ying Cao, Weiwei Liu, Danhua Wang, Piaoping Kong, Zhihua Tao

Background

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

Conclusions

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.

Methods

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.

Results

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. Conclusions: 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.

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