Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia
While the positive association between automated intact fibroblast growth factor (FGF) 23 measurement kit (Determinar CL FGF23 [CL]) and the former assay (Kainos [KI]), and clinical utility of CL was well established, the clinical performance of Medfrontier FGF23 (MED), which was the manual intact F...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-06-01
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| Series: | Bone Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352187223000074 |
| _version_ | 1797798048398573568 |
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| author | Hajime Kato Hiromi Miyazaki Takehide Kimura Yoshitomo Hoshino Naoko Hidaka Minae Koga Masaomi Nangaku Noriko Makita Nobuaki Ito |
| author_facet | Hajime Kato Hiromi Miyazaki Takehide Kimura Yoshitomo Hoshino Naoko Hidaka Minae Koga Masaomi Nangaku Noriko Makita Nobuaki Ito |
| author_sort | Hajime Kato |
| collection | DOAJ |
| description | While the positive association between automated intact fibroblast growth factor (FGF) 23 measurement kit (Determinar CL FGF23 [CL]) and the former assay (Kainos [KI]), and clinical utility of CL was well established, the clinical performance of Medfrontier FGF23 (MED), which was the manual intact FGF23 measurement kit with same antibody set as CL, has not yet been validated. Therefore, this study aims to compare MED FGF23 levels to KI FGF23 levels. A total of 380 samples were collected from healthy individuals, and 200 samples were collected from 20 patients with chronic hypophosphatemia. The intact FGF23 level of each sample was measured by KI and MED. Among the healthy individuals, the reference range of MED FGF23 levels was 18.6–59.8 pg/mL when calculated as the average ± 2 standard deviations. When compared with KI FGF23 levels, MED FGF23 levels were lower than KI levels both among samples from healthy individuals (KI FGF23, 40.9 [interquartile (IQR), 31.1–50.6]; MED FGF23, 38.0 [IQR, 31.5–45.7]; p value = 0.02) and among samples from patients with chronic hypophosphatemia (KI FGF23, 172.5 [IQR, 115.8–290.7]; MED FGF23, 130.2 [IQR, 93.6–247.0]; p value = 0.003). The linear regression analysis showed that the correlation between KI FGF23 and MED FGF23 was interpreted as a slope of 0.83 with a y-intercept of 0.53, revealing good linearity (R2 = 0.99). This study showed that the discrepancy between KI and MED was very similar to the previously reported data between KI and CL. |
| first_indexed | 2024-03-13T03:57:35Z |
| format | Article |
| id | doaj.art-14d5828947fa4cd498b80311e39904f3 |
| institution | Directory Open Access Journal |
| issn | 2352-1872 |
| language | English |
| last_indexed | 2024-03-13T03:57:35Z |
| publishDate | 2023-06-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Bone Reports |
| spelling | doaj.art-14d5828947fa4cd498b80311e39904f32023-06-22T05:03:12ZengElsevierBone Reports2352-18722023-06-0118101659Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemiaHajime Kato0Hiromi Miyazaki1Takehide Kimura2Yoshitomo Hoshino3Naoko Hidaka4Minae Koga5Masaomi Nangaku6Noriko Makita7Nobuaki Ito8Division of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanMinaris Medical Co., Ltd., 600-1, Minami-ishiki, Nagaizumi-cho, Sunto-gun, Shizuoka 411-0932, JapanMinaris Medical Co., Ltd., 600-1, Minami-ishiki, Nagaizumi-cho, Sunto-gun, Shizuoka 411-0932, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, JapanDivision of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Osteoporosis Center, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan; Corresponding author at: Division of Nephrology and Endocrinology, The University of Tokyo Hospital, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan.While the positive association between automated intact fibroblast growth factor (FGF) 23 measurement kit (Determinar CL FGF23 [CL]) and the former assay (Kainos [KI]), and clinical utility of CL was well established, the clinical performance of Medfrontier FGF23 (MED), which was the manual intact FGF23 measurement kit with same antibody set as CL, has not yet been validated. Therefore, this study aims to compare MED FGF23 levels to KI FGF23 levels. A total of 380 samples were collected from healthy individuals, and 200 samples were collected from 20 patients with chronic hypophosphatemia. The intact FGF23 level of each sample was measured by KI and MED. Among the healthy individuals, the reference range of MED FGF23 levels was 18.6–59.8 pg/mL when calculated as the average ± 2 standard deviations. When compared with KI FGF23 levels, MED FGF23 levels were lower than KI levels both among samples from healthy individuals (KI FGF23, 40.9 [interquartile (IQR), 31.1–50.6]; MED FGF23, 38.0 [IQR, 31.5–45.7]; p value = 0.02) and among samples from patients with chronic hypophosphatemia (KI FGF23, 172.5 [IQR, 115.8–290.7]; MED FGF23, 130.2 [IQR, 93.6–247.0]; p value = 0.003). The linear regression analysis showed that the correlation between KI FGF23 and MED FGF23 was interpreted as a slope of 0.83 with a y-intercept of 0.53, revealing good linearity (R2 = 0.99). This study showed that the discrepancy between KI and MED was very similar to the previously reported data between KI and CL.http://www.sciencedirect.com/science/article/pii/S2352187223000074Fibroblast growth factor 23ImmunoassayHypophosphatemiaX-linked hypophosphatemic rickets/osteomalaciaTumor-induced osteomalacia |
| spellingShingle | Hajime Kato Hiromi Miyazaki Takehide Kimura Yoshitomo Hoshino Naoko Hidaka Minae Koga Masaomi Nangaku Noriko Makita Nobuaki Ito Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia Bone Reports Fibroblast growth factor 23 Immunoassay Hypophosphatemia X-linked hypophosphatemic rickets/osteomalacia Tumor-induced osteomalacia |
| title | Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| title_full | Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| title_fullStr | Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| title_full_unstemmed | Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| title_short | Clinical performance of a new intact FGF23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| title_sort | clinical performance of a new intact fgf23 immunoassay in healthy individuals and patients with chronic hypophosphatemia |
| topic | Fibroblast growth factor 23 Immunoassay Hypophosphatemia X-linked hypophosphatemic rickets/osteomalacia Tumor-induced osteomalacia |
| url | http://www.sciencedirect.com/science/article/pii/S2352187223000074 |
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