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13.07.2021 | Original Article

Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23

verfasst von: Nobuaki Ito, Takuo Kubota, Sachiko Kitanaka, Ikuma Fujiwara, Masanori Adachi, Yasuhiro Takeuchi, Hitomi Yamagami, Takehide Kimura, Tatsuya Shinoda, Masanori Minagawa, Ryo Okazaki, Keiichi Ozono, Yoshiki Seino, Seiji Fukumoto

Erschienen in: Journal of Bone and Mineral Metabolism | Ausgabe 6/2021

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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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Titel: Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23
verfasst von: Nobuaki Ito
Takuo Kubota
Sachiko Kitanaka
Ikuma Fujiwara
Masanori Adachi
Yasuhiro Takeuchi
Hitomi Yamagami
Takehide Kimura
Tatsuya Shinoda
Masanori Minagawa
Ryo Okazaki
Keiichi Ozono
Yoshiki Seino
Seiji Fukumoto
Publikationsdatum: 13.07.2021
Verlag: Springer Singapore
Erschienen in: Journal of Bone and Mineral Metabolism / Ausgabe 6/2021
Print ISSN: 0914-8779
Elektronische ISSN: 1435-5604
DOI: https://doi.org/10.1007/s00774-021-01250-1

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Abstract

Introduction

Materials and methods

Results

Conclusion

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