Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer
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...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2023-09-01
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| Series: | Frontiers in Bioengineering and Biotechnology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fbioe.2023.1227357/full |
| _version_ | 1797678795474337792 |
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| author | Yoshiyuki Arai Dong Wang Miki Takeuchi Sosuke Utsunomiya Takuma Degawa Atsushi Kai Hisashi Ichikawa Ryotaro Chiba Toru Yoshimura |
| author_facet | Yoshiyuki Arai Dong Wang Miki Takeuchi Sosuke Utsunomiya Takuma Degawa Atsushi Kai Hisashi Ichikawa Ryotaro Chiba Toru Yoshimura |
| author_sort | Yoshiyuki Arai |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T23:05:07Z |
| format | Article |
| id | doaj.art-06f11e8af62e4df8b8598e84cb0ef16a |
| institution | Directory Open Access Journal |
| issn | 2296-4185 |
| language | English |
| last_indexed | 2024-03-11T23:05:07Z |
| publishDate | 2023-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Bioengineering and Biotechnology |
| spelling | doaj.art-06f11e8af62e4df8b8598e84cb0ef16a2023-09-21T13:19:11ZengFrontiers Media S.A.Frontiers in Bioengineering and Biotechnology2296-41852023-09-011110.3389/fbioe.2023.12273571227357Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzerYoshiyuki AraiDong WangMiki TakeuchiSosuke UtsunomiyaTakuma DegawaAtsushi KaiHisashi IchikawaRyotaro ChibaToru YoshimuraRegular 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.https://www.frontiersin.org/articles/10.3389/fbioe.2023.1227357/fulldigital ELISAquantitativesmall sample volumeTSHultrasensitive |
| spellingShingle | Yoshiyuki Arai Dong Wang Miki Takeuchi Sosuke Utsunomiya Takuma Degawa Atsushi Kai Hisashi Ichikawa Ryotaro Chiba Toru Yoshimura Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer Frontiers in Bioengineering and Biotechnology digital ELISA quantitative small sample volume TSH ultrasensitive |
| title | Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer |
| title_full | Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer |
| title_fullStr | Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer |
| title_full_unstemmed | Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer |
| title_short | Development of a quantitative thyroid-stimulating hormone assay system for a benchtop digital ELISA desktop analyzer |
| title_sort | development of a quantitative thyroid stimulating hormone assay system for a benchtop digital elisa desktop analyzer |
| topic | digital ELISA quantitative small sample volume TSH ultrasensitive |
| url | https://www.frontiersin.org/articles/10.3389/fbioe.2023.1227357/full |
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