Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)

A laboratory-developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used in the same laboratory (i.e., an in-house test). In this study, a metabolomics-based LDT was developed. This test involves a blood plasma preparation, direct-infusion mass spectrometry ana...

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Main Authors: Petr G. Lokhov, Oxana P. Trifonova, Dmitry L. Maslov, Steven Lichtenberg, Elena E. Balashova
Format: Article
Language:English
Published: MDPI AG 2020-05-01
Series:Diagnostics
Subjects:
Online Access:https://www.mdpi.com/2075-4418/10/5/332
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author Petr G. Lokhov
Oxana P. Trifonova
Dmitry L. Maslov
Steven Lichtenberg
Elena E. Balashova
author_facet Petr G. Lokhov
Oxana P. Trifonova
Dmitry L. Maslov
Steven Lichtenberg
Elena E. Balashova
author_sort Petr G. Lokhov
collection DOAJ
description A laboratory-developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used in the same laboratory (i.e., an in-house test). In this study, a metabolomics-based LDT was developed. This test involves a blood plasma preparation, direct-infusion mass spectrometry analysis with a high-resolution mass spectrometer, alignment and normalization of mass peaks using original algorithms, metabolite annotation by a biochemical context-driven algorithm, detection of overrepresented metabolic pathways and results in a visualization in the form of a pathway names cloud. The LDT was applied to detect early stage Parkinson’s disease (PD)—the diagnosis of which currently requires great effort due to the lack of available laboratory tests. In a case–control study (<i>n</i> = 56), the LDT revealed a statistically sound pattern in the PD-relevant pathways. Usage of the LDT for individuals confirmed its ability to reveal this pattern and thus diagnose PD at the early-stage (1–2.5 stages, according to Hoehn and Yahr scale). The detection of this pattern by LDT could diagnose PD with a specificity of 64%, sensitivity of 86% and an accuracy of 75%. Thus, this LDT can be used for further widespread testing.
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spelling doaj.art-77a3ff95971344c1aba8e58eda3a64392023-11-20T01:13:12ZengMDPI AGDiagnostics2075-44182020-05-0110533210.3390/diagnostics10050332Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)Petr G. Lokhov0Oxana P. Trifonova1Dmitry L. Maslov2Steven Lichtenberg3Elena E. Balashova4Institute of Biomedical Chemistry, 10 building 8, Pogodinskaya Street, 119121 Moscow, RussiaInstitute of Biomedical Chemistry, 10 building 8, Pogodinskaya Street, 119121 Moscow, RussiaInstitute of Biomedical Chemistry, 10 building 8, Pogodinskaya Street, 119121 Moscow, RussiaMetabometrics, Inc., 651 N Broad St., Suite 205 #1370, Middletown, DE 19709, USAInstitute of Biomedical Chemistry, 10 building 8, Pogodinskaya Street, 119121 Moscow, RussiaA laboratory-developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used in the same laboratory (i.e., an in-house test). In this study, a metabolomics-based LDT was developed. This test involves a blood plasma preparation, direct-infusion mass spectrometry analysis with a high-resolution mass spectrometer, alignment and normalization of mass peaks using original algorithms, metabolite annotation by a biochemical context-driven algorithm, detection of overrepresented metabolic pathways and results in a visualization in the form of a pathway names cloud. The LDT was applied to detect early stage Parkinson’s disease (PD)—the diagnosis of which currently requires great effort due to the lack of available laboratory tests. In a case–control study (<i>n</i> = 56), the LDT revealed a statistically sound pattern in the PD-relevant pathways. Usage of the LDT for individuals confirmed its ability to reveal this pattern and thus diagnose PD at the early-stage (1–2.5 stages, according to Hoehn and Yahr scale). The detection of this pattern by LDT could diagnose PD with a specificity of 64%, sensitivity of 86% and an accuracy of 75%. Thus, this LDT can be used for further widespread testing.https://www.mdpi.com/2075-4418/10/5/332metabolomicsParkinson’s diseasediagnosticslaboratory-developed testmass spectrometryblood plasma
spellingShingle Petr G. Lokhov
Oxana P. Trifonova
Dmitry L. Maslov
Steven Lichtenberg
Elena E. Balashova
Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
Diagnostics
metabolomics
Parkinson’s disease
diagnostics
laboratory-developed test
mass spectrometry
blood plasma
title Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
title_full Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
title_fullStr Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
title_full_unstemmed Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
title_short Diagnosis of Parkinson’s Disease by A Metabolomics-Based Laboratory-Developed Test (LDT)
title_sort diagnosis of parkinson s disease by a metabolomics based laboratory developed test ldt
topic metabolomics
Parkinson’s disease
diagnostics
laboratory-developed test
mass spectrometry
blood plasma
url https://www.mdpi.com/2075-4418/10/5/332
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