Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23
Clinical performance of a novel chemiluminescent enzyme immunoassay for FGF23
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DOI：
10.1007/s00774-021-01250-1
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发表时间：
2021-07-13
影响因子：
3.3
通讯作者：
Fukumoto, Seiji
中科院分区：
文献类型：
--
作者：
Ito, Nobuaki;Kubota, Takuo;Fukumoto, Seiji
前言成纤维细胞生长因子23（FGF 23）的测量已被报道是临床上有用的慢性低磷血症的鉴别诊断。但是，日本仅提供研究用检测试剂盒。因此，本研究的目的是检查用于测量FGF 23的新型自动荧光酶免疫测定法的临床实用性。材料和方法参与者于2015年7月至2017年1月在日本的六个机构招募。38例X连锁低磷血症性佝偻病患者（XLH 15例男性，23例女性，年龄0-66岁）、5例肿瘤诱导的骨软化症患者（TIO 3例男性，2例女性，年龄60-73岁）和22例因其他因素引起的低磷血症患者（11例男性，11例女性，年龄1-75岁）参加了本研究。结果以日本佝偻病/骨软化症诊断指南中30.0 pg/mL为FGF 23的临床临界值，诊断非维生素D缺乏的FGF 23相关性低磷血症佝偻病/骨软化症（疾病组-1）的敏感性和特异性分别为100%和81.8%，与非FGF 23相关性低磷血症（疾病组-2）相区别。此外，FGF 23相关的低磷酸盐血症伴维生素D缺乏的诊断灵敏度保持在100%。在疾病组-2中FGF 23水平>= 30.0 pg/mL的四名患者中，由于肺和前列腺小细胞癌中FGF 23的异位产生，具有相对较高FGF 23值的两名患者被怀疑患有真正的FGF 23相关的低磷酸盐血症。结论新的FGF 23检测方法可用于低磷血症性佝偻病/骨软化症的鉴别诊断。
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.