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A new diagnostic indication device of a biomarker growth differentiation factor 15 for mitochondrial diseases: From laboratory to automated inspection
Author(s) -
Koga Yasutoshi,
Povalko Nataliya,
Inoue Eisuke,
Ishii Akiko,
Fujii Katsunori,
Fujii Tatsuya,
Murayama Kei,
Mogami Yukiko,
Hata Ikue,
Ikawa Masamichi,
Fukami Kei,
Fukumoto Yoshihiro,
Nomura Masatoshi,
Ichikawa Kazuki,
Yoshida Kaori
Publication year - 2021
Publication title -
journal of inherited metabolic disease
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.462
H-Index - 102
eISSN - 1573-2665
pISSN - 0141-8955
DOI - 10.1002/jimd.12317
Subject(s) - gdf15 , interquartile range , biomarker , quartile , medicine , confidence interval , immunoassay , gastroenterology , receiver operating characteristic , immunology , antibody , biology , biochemistry
Mitochondrial diseases (MDs) are occasionally difficult to diagnose. Growth differentiation factor 15 (GDF15) has been reported as a biomarker useful for not only diagnosing MDs, but also evaluating disease severity and therapeutic efficacy. To enable the measurement of serum GDF15 concentrations at medical institutions, we developed a new latex‐enhanced turbidimetric immunoassay (LTIA) as an automated diagnostic indication test for MDs. We also examined the equivalency of specificity and sensitivity in measuring serum GDF15 concentrations between a commercially available enzyme‐linked immunosorbent assay (ELISA) kit and a novel LTIA device in patients with MDs, disease controls, and healthy controls. A clinical performance study used a newly developed LTIA device and an existing ELISA kit to measure the concentrations of GDF15 in 35 MD patients, 111 disease controls, and 86 healthy controls. The median (first quartile‐third quartile) of serum GDF15 concentrations measured with the LTIA device was significantly higher ( P < .001) in MD patients (1389.0 U/mL [869.5‐1776.0 U/mL]) than in healthy controls (380.5 U/mL [330.2‐471.8 U/mL]); the interquartile ranges did not overlap between MD patients and healthy controls. The areas under the curve in disease and healthy controls were 0.812 (95% confidence interval [CI]: 0.734‐0.886) and 0.951 (95% CI: 0.910‐0.992), respectively. The automated, high‐throughput technology‐based LTIA device has definite advantages over the ELISA kit in shorter processing time and lower estimated cost per sample measurement. The LTIA device of GDF15 may be a sufficiently reliable, frontline, diagnostic indicator of individuals with suspected MDs in the general population.