Analytical and Clinical validation of rapid chemiluminescence enzyme immunoassay for urinary thioredoxin, an oxidative stress-dependent early biomarker of acute kidney injury.

Seiji Yokoi,Kenji Kasuno,Kazuhisa Nishimori,Sho Nishikawa,Yudai Nishikawa,Sayu Morita,Mamiko Kobayashi,Sachiko Fukushima,Daisuke Mikami,Naoki Takahashi,Yumiko Oota,Hideki Kimura,Yoshihiro Soya,Shinsuke Kimata,Kengo Nishimura,Takahiko Ono,Eri Muso,Haruyoshi Yoshida,Junji Yodoi,Masayuki Iwano

Analytical and Clinical validation of rapid chemiluminescence enzyme immunoassay for urinary thioredoxin, an oxidative stress-dependent early biomarker of acute kidney injury.

2020

BACKGROUND: Oxidative stress is now recognized to be an important therapeutic target in kidney diseases. However, there are currently no biomarkers that can be used clinically to diagnose renal oxidative stress. METHODS: A rapid assay system for urinary thioredoxin 1, an oxidative stress-dependent biomarker of acute kidney injury (AKI), was developed as a chemiluminescence enzyme immunoassay and validated analytically and clinically. RESULTS: Analytic evaluation revealed that hemolytic hemoglobin caused measurements to be abnormally high, above the detectable range. However, urine sediment containing red blood cells did not affect the measurements. Assays using our proposed chemiluminescence enzyme immunoassay were completed within as little as 6 min, whereas a conventional ELISA >4 h. Aciduria

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