Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer

Frontiers in Bioengineering and Biotechnology

Bioengineering and Biotechnology

Hisashi Ichikawa¹  Atsushi Kai¹  Yoshiyuki Arai¹  Ryotaro Chiba¹  Sosuke Utsunomiya¹  Dong Wang¹  Miki Takeuchi¹  Takuma Degawa¹  Toru Yoshimura² 

[1] Research and Development, Abbott Japan LLC, Chiba, Japan;null;

关键词: digital ELISA;    quantitative;    small sample volume;    TSH;    ultrasensitive;   

DOI  :  10.3389/fbioe.2023.1227357

 received in 2023-05-23, accepted in 2023-09-04,  发布年份 2023

来源: Frontiers

【 摘 要 】

Regular checkups for thyroid-stimulating hormone (TSH) levels are essential for the diagnosis of thyroid disease. The enzyme-linked immunosorbent assay (ELISA) technique is a standard method for detecting TSH in the serum or plasma of hospitalized patients. A recently developed next-generation ELISA, the digital immunoassay (d-IA), has facilitated detection of molecules with ultra-high-sensitivity. In this study, we developed a TSH assay system using the d-IA platform. By utilizing the ultrasensitivity of d-IA, we were able to use a sample volume of as little as 5 µL for each assay (the dead volume was 5 µL). The limits of blank, detection, and quantification (i.e., functional sensitivity), were 0.000346, 0.001953, and 0.002280 μIU/mL, respectively, and the precision of the total coefficient of variation did not exceed 10%. The correlation between serum and plasma levels indicated good agreement. Thus, our system successfully measured TSH using d-IA with a small sample volume and equal functional sensitivity to the current third generation like ARCHITECT TSH assay, which has a functional sensitivity of 0.0038 μIU/mL.

【 授权许可】

Unknown   
Copyright © 2023 Arai, Wang, Takeuchi, Utsunomiya, Degawa, Kai, Ichikawa, Chiba and Yoshimura.