Objective: To validate in serum and/or cerebrospinal fluid (CSF) diagnostic biomarker candidates identified from a systematic literature search including markers on axonal and synaptic integrity, microglia and synuclein in a single-center cross-sectional cohort of subjects with Parkinson’s disease (PD), neurological and healthy controls (NC and HC).

Background: Objective diagnostic biomarkers are needed to support the clinical diagnosis and clinical trials.

Method: Commercially available kits or published protocols for the quantification of the candidate markers were validated by determining the lower limit of detection, precision, parallelism, spike recovery, dilution linearity, and plate to plate variabilty. Upon validation we selected assays for the following marker candidates: neurofilament light chain (NfL), phosphorylated neurofilament heavy chain (pNfH), tau protein (tau), Chitinase-3-like protein 1 (YKL-40), glial fibrillary acidic protein (GFAP), Calcium-binding protein B (S100B), total and phosphorylated α-synuclein (aSyn and phospho-aSyn) and triggering receptor expressed on myeloid cells 2 (Trem-2) as well as Ubiquitin C-terminal hydrolase L1 (UCHL1). The cohort comprised 358 PD subjects, 80 neurological controls with tau-protein aggregation disorders including PSP, AD, CBD and FTD/ALS, and 20 matched healthy control subjects.

Results: The markers and group comparisons are shown in Table [1]

Conclusion: Most marker candidates validated here showed significant difference to the healthy controls, but the stratification of PD versus clinically relevant neurological controls remain challenging. The levels of NfL, Trem-2 and S100B were also interesting as a serum marker.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/systematic-assessment-of-10-diagnostic-marker-candidates-in-biological-fluids-for-parkinsons-disease/