Analytical performance of a new automated chemiluminescent magnetic immunoassays for soluble PD-1, PD-L1, and CTLA-4 in human plasma

Megumi Goto, Kenji Chamoto, Keiko Higuchi, Saya Yamashita, Kenta Noda, Takuya Iino, Masahiro Miura, Toshinari Yamasaki, Osamu Ogawa, Makoto Sonobe, Hiroshi Date, Junzo Hamanishi, Masaki Mandai, Yoshimasa Tanaka, Shunsuke Chikuma, Ryusuke Hatae, Manabu Muto, Sachiko Minamiguchi, Nagahiro Minato, Tasuku Honjo

Research output: Contribution to journalArticlepeer-review

34 Citations (Scopus)


Current clinically approved biomarkers for the PD-1 blockade cancer immunotherapy are based entirely on the properties of tumour cells. With increasing awareness of clinical responses, more precise biomarkers for the efficacy are required based on immune properties. In particular, expression levels of immune checkpoint-associated molecules such as PD-1, PD-L1, and CTLA-4 would be critical to evaluate the immune state of individuals. Although quantification of their soluble form leased from the membrane will provide quick evaluation of patients’ immune status, available methods such as enzyme-linked immunosorbent assays to measure these soluble factors have limitations in sensitivity and reproducibility for clinical use. To overcome these problems, we developed a rapid and sensitive immunoassay system based on chemiluminescent magnetic technology. The system is fully automated, providing high reproducibility. Application of this system to plasma of patients with several types of tumours demonstrated that soluble PD-1, PD-L1, and CTLA-4 levels were increased compared to those of healthy controls and varied among tumour types. The sensitivity and detection range were sufficient for evaluating plasma concentrations before and after the surgical ablation of cancers. Therefore, our newly developed system shows potential for accurate detection of soluble PD-1, PD-L1, and CTLA-4 levels in the clinical practice.

Original languageEnglish
Article number10144
JournalScientific reports
Issue number1
Publication statusPublished - 2019 Dec 1

ASJC Scopus subject areas

  • General


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