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Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23

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Abstract

Introduction

Measurement of fibroblast growth factor 23 (FGF23) has been reported to be clinically useful for the differential diagnosis of chronic hypophosphatemia. However, assays for research use only are available in Japan. Thus, the objective of this study was to examine the clinical utility of a novel and automated chemiluminescent enzyme immunoassay for the measurement of FGF23.

Materials and methods

Participants were recruited from July 2015 to January 2017 at six facilities in Japan. Thirty-eight patients with X-linked hypophosphatemic rickets (XLH 15 males, 23 females, age 0–66 years), five patients with tumour-induced osteomalacia (TIO 3 males, 2 females, age 60–73 years), and twenty-two patients with hypophosphatemia (11 males, 11 females, age 1–75 years) caused due to other factors participated in this study.

Results

With the clinical cut-off value of FGF23 at 30.0 pg/mL indicated in the Diagnostic Guideline of Rickets/Osteomalacia in Japan, the sensitivity and specificity of FGF23-related hypophosphatemic rickets/osteomalacia without vitamin D deficiency (disease group-1) were 100% and 81.8%, respectively, which distinguished it from non-FGF23-related hypophosphatemia (disease group-2). Furthermore, the diagnostic sensitivity of FGF23-related hypophosphatemia with vitamin D deficiency remained at 100%. Among the four patients with FGF23 levels ≥ 30.0 pg/mL in disease group-2, two patients with relatively higher FGF23 values were suspected to have genuine FGF23-related hypophosphatemia, due to the ectopic production of FGF23 in pulmonary and prostate small cell carcinomas.

Conclusion

The novel FGF23 assay tested in this study is useful for the differential diagnosis of hypophosphatemic rickets/osteomalacia in a clinical setting.

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Funding

This study was supported by Minaris Medical Co., Ltd.

Author information

Authors and Affiliations

  1. Division of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Nobuaki Ito

  2. Department of Pediatrics, Graduate School of Medicine, Osaka University, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan

    Takuo Kubota & Keiichi Ozono

  3. Department of Pediatrics, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan

    Sachiko Kitanaka

  4. Department of Pediatric Endocrinology and Environmental Medicine, Graduate School of Medicine, Tohoku University, 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan

    Ikuma Fujiwara

  5. Department of Endocrinology and Metabolism, Kanagawa Children’s Medical Center, 2-138-4 Mutsukawa, Minami-ku, Yokohama, Kanagawa, 232-8555, Japan

    Masanori Adachi

  6. Endocrine Center, Toranomon Hospital, 2-2-2, Toranomon, Minato-ku, Tokyo, 105-8470, Japan

    Yasuhiro Takeuchi

  7. Okinaka Memorial Institute for Medical Research, Toranomon, Minato-ku, Tokyo, 105-8470, Japan

    Yasuhiro Takeuchi

  8. Minaris Medical Co., Ltd., 1-8-10 Harumi, Chuo-ku, Tokyo, 104-6004, Japan

    Hitomi Yamagami, Takehide Kimura & Tatsuya Shinoda

  9. Division of Endocrinology, Chiba Children’s Hospital, 579-1 Hetacho, Midoriku, Chiba, 266-0007, Japan

    Masanori Minagawa

  10. Division of Endocrinology and Metabolism, Third Department of Medicine, Teikyo University Chiba Medical Center, Ichihara, Chiba, Japan

    Ryo Okazaki

  11. Department of Pediatrics, Osaka Hospital, Japan Community Healthcare Organization (JCHO), 4-2-78, Fukushima, Fukushima-ku, Osaka, 553-0003, Japan

    Yoshiki Seino

  12. Fujii Memorial Institute of Medical Sciences, Institute of Advanced Medical Sciences, Tokushima University, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan

    Seiji Fukumoto

Authors
  1. Nobuaki Ito
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  2. Takuo Kubota
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  3. Sachiko Kitanaka
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  14. Seiji Fukumoto
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Contributions

All authors have accepted responsibility for the entire content of this manuscript and approved its submission. Conceptualisation: NI, KO, and SF. Formal analysis and investigation: NI. Writing—original draft preparation: NI, and TK. Writing—review and editing: NI, and SF. Funding acquisition: NI, TK, SK, IF, MA, YT, MM, RO, KO, YS, and SF. Resources: NI, TK, SK, IF, MA, YT, HY, TK, TS, MM, RO, KO, YS, and SF. Supervision: NI, KO, and SF.

Corresponding author

Correspondence to Nobuaki Ito.

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Conflict of interest

The authors declare that they have no conflict of interest.

Informed consent

Informed consent was obtained from all individuals included in this study.

Ethical approval

This study was approved by the ethical review board of the six investigational sites.

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Ito, N., Kubota, T., Kitanaka, S. et al. Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23. J Bone Miner Metab 39, 1066–1075 (2021). https://doi.org/10.1007/s00774-021-01250-1

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  • DOI: https://doi.org/10.1007/s00774-021-01250-1

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