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A new diagnostic indication device of a biomarker growth differentiation factor 15 for mitochondrial diseases: From laboratory to automated inspection

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dc.contributor.author Koga Y.
dc.contributor.author Povalko N.
dc.contributor.author Inoue E.
dc.contributor.author Ishii A.
dc.contributor.author Fujii K.
dc.contributor.author Fujii T.
dc.contributor.author Murayama K.
dc.contributor.author Mogami Y.
dc.contributor.author Hata I.
dc.contributor.author Ikawa M.
dc.contributor.author Fukami K.
dc.contributor.author Fukumoto Y.
dc.contributor.author Nomura M.
dc.contributor.author Ichikawa K.
dc.contributor.author Yoshida K.
dc.date.accessioned 2021-02-25T20:33:54Z
dc.date.available 2021-02-25T20:33:54Z
dc.date.issued 2020
dc.identifier.issn 0141-8955
dc.identifier.uri https://dspace.kpfu.ru/xmlui/handle/net/161750
dc.description.abstract © 2020 The Authors. Journal of Inherited Metabolic Disease published by John Wiley & Sons Ltd on behalf of SSIEM. 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.
dc.relation.ispartofseries Journal of Inherited Metabolic Disease
dc.subject biomarker
dc.subject diagnostic indication device
dc.subject GDF15
dc.subject latex
dc.subject LTIA
dc.subject mitochondrial disease
dc.title A new diagnostic indication device of a biomarker growth differentiation factor 15 for mitochondrial diseases: From laboratory to automated inspection
dc.type Article
dc.collection Публикации сотрудников КФУ
dc.source.id SCOPUS01418955-2020-SID85092102093

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  • Публикации сотрудников КФУ Scopus [24551]
    Коллекция содержит публикации сотрудников Казанского федерального (до 2010 года Казанского государственного) университета, проиндексированные в БД Scopus, начиная с 1970г.

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