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.

中文翻译：

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整体代谢组学实验室开发的测试（LDT）：帕金森氏病早期诊断的开发和应用

实验室开发的测试（LDT）是一种体外诊断测试，在单个实验室中开发和使用。完整的代谢组学LDT结合了人类代谢途径的当前可用数据，疾病和其他条件下人类血液中低分子量化合物浓度的变化及其在人体中的普遍位置。也就是说，LDT将所有与疾病诊断和高分辨率质谱法相关的累积代谢数据与内部软件进行的数据处理一起使用。在这项研究中，LDT用于诊断早期帕金森氏病（PD），目前尚缺乏可用的实验室检查。对血浆样品使用LDT证实了其诊断能力为73％。诊断是基于相关数据，例如检测与PD和其他神经退行性疾病相关的代谢物集合。另外，证明了LDT检测血液中低分子量化合物正常组成的能力，从而在分子水平上提供了健康的定义。这种LDT方法作为一种筛查工具，可以用于其他疾病的进一步广泛检测，因为代谢组学LDT所属的“组学”检测涵盖了多种疾病。