Assessment of ELISA-based method for the routine examination of serum indoxyl sulfate in patients with chronic kidney diseaseSummary
Shuangdi Duan,
Jiayi Pi,
Chun-Hsiang Wang,
Yi-Chou Hou,
Chung-Ying Andy Lee,
Cheng-Jui Lin,
Liyang Shi,
Kung-Chia Young,
Hung-Yu Sun
Affiliations
Shuangdi Duan
College of Biology, Hunan University, Changsha 410082, China; Institute of Pathogen Biology and Immunology of College of Biology, Hunan Provincial Key Laboratory of Medical Virology, Hunan University, Changsha 410082, China
Jiayi Pi
College of Biology, Hunan University, Changsha 410082, China; Institute of Pathogen Biology and Immunology of College of Biology, Hunan Provincial Key Laboratory of Medical Virology, Hunan University, Changsha 410082, China
Chun-Hsiang Wang
Division of Gastroenterology, Tainan Municipal Hospital, Tainan 700, Taiwan
Yi-Chou Hou
Division of Nephrology, Department of Medicine, Cardinal-Tien Hospital, New Taipei City 23148, Taiwan; School of Medicine, Fu Jen Catholic University, New Taipei City 24205, Taiwan
Chung-Ying Andy Lee
Dalian Zhen-Ao Bio-Tech Co., Ltd, Dalian 116000, China
Cheng-Jui Lin
Division of Nephrology, Department of Internal Medicine, MacKay Memorial Hospital, Taipei 100, Taiwan; Department of Medicine, Mackay Medical College, New Taipei City 252, Taiwan; Mackay Junior College of Medicine, Nursing and Management, Taipei 100, Taiwan
Liyang Shi
College of Biology, Hunan University, Changsha 410082, China
Kung-Chia Young
Department of Medical Laboratory Science and Biotechnology, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan; Institute of Basic Medicine, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan; Center of Infectious Disease and Signaling Research, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan
Hung-Yu Sun
Institute of Basic Medicine, College of Medicine, National Cheng Kung University, Tainan 70101, Taiwan; Department of Physiology, College of Medicine, National Cheng Kung University, Tainan, Taiwan; Corresponding author.
Introduction: Indoxyl sulfate (IS), a protein-bound uremic toxin, is associated with kidney function and chronic kidney disease (CKD)-related complications. Currently, serum IS levels are primarily quantified using mass spectrometry-based methods, which are not feasible for routine clinical examinations. Methods: The efficiencies of three commercial ELISA kits in determination of serum IS were validated by comparing with ultra-performance liquid chromatography (UPLC)-MS/MS-based method using Bland-Altman analysis. The associations between kidney parameters and serum IS levels determined by ELISA kit from Leadgene and UPLC-MS/MS were evaluated by Spearman correlation coefficient in a CKD validation cohort. Results: ELISA kit from Leadgene showed clinical agreement with UPLC-MS/MS in the determination of serum IS levels (p = 0.084). In patients with CKD, Spearman's correlation analysis revealed a perfect correlation between the IS levels determined using the Leadgene ELISA kit and UPLC-MS/MS (r = 0.964, p < 0.0001). IS levels determined using the Leadgene ELISA kit were associated with the estimated glomerular filtration rate (r = -0.772, p < 0.0001) and serum creatinine concentration (r = 0.824, p < 0.0001) in patients with CKD, and on dialysis (r = 0.557, p = 0.006). Conclusions: The Leadgene ELISA kit exhibits comparable efficacy to UPLC-MS/MS in quantifying serum IS levels, supporting that ELISA would be a personalized method for monitoring the dynamic changes in serum IS levels in dialysis patients to prevent the progression of CKD.