Abstract

Background: A blood-test that could serve as a potential first step in a multi-tiered neurodiagnostic process for ruling out Parkinson’s disease (PD) in primary care settings would be of tremendous value. This study therefore sought to conduct a large-scale cross-validation of our Parkinson’s disease Blood Test (PDBT) for use in primary care settings.

Methods: Serum samples were analyzed from 846 PD and 2291 volunteer controls. Proteomic assays were run on a multiplex biomarker assay platform using Electrochemiluminescence (ECL). Diagnostic accuracy statistics were generated using area under the receiver operating characteristic curve (AUC), Sensitivity (SN), Specificity (SP) and Negative Predictive Value (NPV).

Results: In the training set, the PDBT reached an AUC of 0.98 when distinguishing PD cases from controls with a SN of 0.84 and SP of 0.98. When applied to the test set, the PDBT yielded an AUC of 0.96, SN of 0.79 and SP of 0.97. The PDBT obtained a negative predictive value of 99% for a 2% base rate.

Conclusion: The PDBT was highly successful in discriminating PD patients from control cases and has great potential for providing primary care providers with a rapid, scalable and cost-effective tool for screening out PD.