Abstract
A laboratory-developed test (LDT) is a type of in vitro diagnostic test that is developed and used within a single laboratory. The holistic metabolomic LDT integrating the currently available data on human metabolic pathways, changes in the concentrations of low-molecular-weight compounds in the human blood during diseases and other conditions, and their prevalent location in the body was developed. That is, the LDT uses all of the accumulated metabolic data relevant for disease diagnosis and high-resolution mass spectrometry with data processing by in-house software. In this study, the LDT was applied to diagnose early-stage Parkinson’s disease (PD), which currently lacks available laboratory tests. The use of the LDT for blood plasma samples confirmed its ability for such diagnostics with 73% accuracy. The diagnosis was based on relevant data, such as the detection of overrepresented metabolite sets associated with PD and other neurodegenerative diseases. Additionally, the ability of the LDT to detect normal composition of low-molecular-weight compounds in blood was demonstrated, thus providing a definition of healthy at the molecular level. This LDT approach as a screening tool can be used for the further widespread testing for other diseases, since ‘omics’ tests, to which the metabolomic LDT belongs, cover a variety of them.
Highlights
Metabolomics studies have demonstrated the possibility of using the identification of metabolites for the successful diagnosis of many diseases [1]
The measured masses were submitted to the bioinformatic treatment block of the laboratory-developed test (LDT) that resulted in the annotation of 709 compounds (Table 1)
The developed LDT is based on direct mass spectrometry of laboratory routines
Summary
Metabolomics studies have demonstrated the possibility of using the identification of metabolites for the successful diagnosis of many diseases [1]. These data give hope for the successful application of metabolomics methods in medicine. Considering omics tests as in-house laboratory-developed tests (LDTs) is the most evident solution to this problem. An LDT is a type of in vitro diagnostic test that is developed and used within the same laboratory [4] and is used to measure a wide range of substances, including nucleic acids, proteins, and low-molecular-weight compounds in different biological samples. An LDT comprising the latest advancements in metabolomics was developed
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