Evidence map›Paper›PMID 34351500›Full record

ArticleJournal of bone and mineral metabolism2022

Performance evaluation of the new chemiluminescent intact FGF23 assay relative to the existing assay system.

Hajime Kato, Naoko Hidaka, Minae Koga, Noriyuki Ogawa, Shichihiro Takahashi, Hiromi Miyazaki, Masaomi Nangaku, Noriko Makita, Nobuaki Ito

Abstract read
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Article in Journal of bone and mineral metabolism, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Fibroblast Growth Factor 23, Urinary Phosphate, and Risk of Progression of CKD.Clinical journal of the American Society of Nephrology : CJASN · 2026
    Article
  3. Article
  4. Article
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  9. Article
  10. Determination of FGF23 Levels for the Diagnosis of FGF23-Mediated Hypophosphatemia.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Article
  11. Identification of ENPP1 Haploinsufficiency in Patients With Diffuse Idiopathic Skeletal Hyperostosis and Early-Onset Osteoporosis.Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 2022
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Hajime KatoDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Naoko HidakaDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Minae KogaDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Noriyuki OgawaMinaris Medical Co., Ltd., 600-1, Minami-ishiki, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-0932, Japan.
Shichihiro TakahashiMinaris Medical Co., Ltd., 600-1, Minami-ishiki, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-0932, Japan.
Hiromi MiyazakiMinaris Medical Co., Ltd., 600-1, Minami-ishiki, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-0932, Japan.
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Noriko MakitaDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
Nobuaki ItoDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. nobitotky@gmail.com.ORCID http://orcid.org/0000-0002-4071-5372

Funding

Hitachi Chemical Diagnostic systems Co., Ltd. 207100000460
6 · The paper itself

Abstract

introductionThis study assessed the performance of a new fully automated immunoassay for fibroblast growth factor (FGF) 23 (Determinar CL FGF23 CL) among healthy individuals and those with chronic hypophosphatemia compared with the previous assay (Kainos FGF23 KI). MATERIALS AND

methodsA total of 380 serum samples from healthy participants were collected to determine the reference range of FGF23 levels with CL. A total of 200 serum samples from 22 hypophosphatemic patients were collected simultaneously to compare the difference in FGF23 levels between CL and KI. The Mann-Whitney U test and linear regression analysis were adopted to assess the differences and linearity between the two assays.

resultsThe median FGF23 levels among healthy individuals was 31.7 (interquartile: 26.4-37.5) pg/mL. When the reference range was calculated as the mean  ± 2 standard deviation (2SD), it was 16.1-49.3 pg/mL. A total of 363 individuals (96%) among normal cases fell in this range. Among 200 samples from patients with chronic hypophosphatemic disorder, the median FGF23 levels analyzed by CL and KI were 123.0 (90.2-237.7) and 172.5 (115.8-290.7) pg/mL. KI yielded significantly higher FGF23 values than CL (p < 0.001). A linear regression model revealed the correlation between KI (x) and CL (y), which had a slope of 0.76 with a y-intercept of -0.32 and high linearity (R

conclusionThe new measurement kit yielded lower FGF23 values when compared with the previous assay. Clinicians should consider this discrepancy when they assay intact FGF23 values with CL.

Indexed as

HypophosphatemiaOsteomalaciaFibroblast Growth FactorsHealth StatusHumansReference ValuesStatistics, NonparametricFibroblast Growth FactorsFanconi syndromeFibroblast growth factor 23HypophosphatemiaTumor-induced osteomalaciaX-linked hypophosphatemic rickets

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.