Comparison between a new assay system, Elecsys® Anti‑p53, and conventional MESACUP™ for the detection of serum anti‑p53 antibodies: A multi‑institutional study

Suzuki,Takashi; Oshima,Yoko; Shiratori,Fumiaki; Nanami,Tatsuki; Yajima,Satoshi; Sumazaki,Makoto; Ushigome,Mitsunori; Sugita,Hironobu; Eberl,Magdalena; Ogata,Hideaki; Hayashida,Tetsu; Nakamura,Seigo; Nakagawa,Tsuyoshi; Shimada,Hideaki

doi:10.3892/mco.2022.2563

August-2022 Volume 17 Issue 2

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August-2022 Volume 17 Issue 2

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Comparison between a new assay system, Elecsys® Anti‑p53, and conventional MESACUP™ for the detection of serum anti‑p53 antibodies: A multi‑institutional study

Authors:
- Takashi Suzuki
- Yoko Oshima
- Fumiaki Shiratori
- Tatsuki Nanami
- Satoshi Yajima
- Makoto Sumazaki
- Mitsunori Ushigome
- Hironobu Sugita
- Magdalena Eberl
- Hideaki Ogata
- Tetsu Hayashida
- Seigo Nakamura
- Tsuyoshi Nakagawa
- Hideaki Shimada
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Affiliations: Department of Surgery, School of Medicine, Graduate School of Medicine, Toho University, Tokyo 142‑8541, Japan, Roche Diagnostics K.K., Tokyo 108‑0075, Japan, Department of Biostatistics and Advanced Data Analytics, Roche Diagnostics GmbH, Penzberg, D‑82377 Bavaria, Germany, Department of General and Gastroenterological Surgery, Keio University, Tokyo 160‑8582, Japan, Division of Breast Surgical Oncology, Showa University, Tokyo 142‑8666, Japan, Division of Breast Surgery, Tokyo Medical and Dental University, Tokyo 113‑8519, Japan

Copyright: © Suzuki et al. This is an open access article distributed under the terms of Creative Commons Attribution License.
Article Number: 130
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Published online on: June 22, 2022

https://doi.org/10.3892/mco.2022.2563
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Abstract

The sensitivity and specificity of a new automated electrochemiluminescence immunoassay system, Elecsys® Anti‑p53 (Elecsys), were compared with that of the conventional serum anti‑p53 antibody (s‑p53‑Ab) enzyme‑linked immunosorbent assay kit [MESACUP anti‑p53 test (MESACUP)]. Elecsys and MESACUP were used to analyze the levels of s‑p53‑Abs in patients with esophageal, colorectal and breast cancer. A total of 532 controls and 288, 235 and 329 patients with esophageal, colorectal and breast cancer, respectively, were enrolled. Additionally, the sera of patients with benign diseases of the esophagus, colorectal system and breast, patients with autoimmune diseases and healthy volunteers were analyzed as controls. Sensitivity and specificity were compared between the two assay systems. Positive agreement rates were 58.7% in all samples, 71.2% in esophageal samples, 73.6% in colorectal samples and 35.1% in breast samples. Negative agreement rates for the different cancer types were ≥97.1% and the overall agreement rates were ≥92.3%. When the specificities of the two assays were aligned for all samples, Elecsys demonstrated higher sensitivities for all types of analyzed cancer together, as well as for esophageal, colorectal and breast cancer, respectively. Although positive concordance between the two assay systems was low in terms of specificity, Elecsys had a higher sensitivity than the MESACUP.

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Journals

International Journal of Molecular Medicine

International Journal of Oncology

Molecular Medicine Reports

Oncology Reports

Experimental and Therapeutic Medicine

Oncology Letters

Biomedical Reports

Molecular and Clinical Oncology

World Academy of Sciences Journal

International Journal of Functional Nutrition

International Journal of Epigenetics

Medicine International

Comparison between a new assay system, Elecsys® Anti‑p53, and conventional MESACUP™ for the detection of serum anti‑p53 antibodies: A multi‑institutional study

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