9. Biomarker Analysis

Blood and CSF samples will be stored according to a strict protocol and standard operating procedure (SOP). Analysis of CSF research samples will take place in the Department of Immunology Laboratory, Central Pathology Laboratory, St. James’s Hospital. ELISA Testing will be performed to measure the levels of the biomarkers T-Tau, P- Tau and Aβ 42. 

Blood samples will also be analysed in The Department of Immunology Laboratory, St James Hospital   and samples will be stored and transported at the end of the study, to an appropriate lab for APOE genotyping.

A portion of each CSF and blood sample will be provided to European collaborating laboratories as part of the BIOMARKAPD project to aid in the standardisation process for CSF biomarkers across Europe and to support the development of a clinical reference laboratory at St. James's Hospital.

As part of BIOMARKAPD, some samples will also be provided to a central biobank in Luxembourg which is ISO certified to aid in the future development of biomarkers for AD across Europe.

9.1 BIOMARKAPD Biobanking Requirements

The Central Biobank is located in Luxembourg (Integrated Biobank of Luxembourg). A number of BIOMARKAPD partners will  each contribute samples for 20-40 subjects. Samples to be stored and collected according to pre-analytical SOPs.

Materials to be collected by each partner:       Overall Consortium Collection:
- Four 0.5 mL aliquots of CSF                           -200 healthy controls
- Two 0.5 mL aliquots of serum                         -200 subjects with (MCI)

Two 0.5 mL aliquots of plasma and whole blood: 200 subjects with Alzheimer’s disease (AD) and 200 with Parkinson’s disease (PD).

For each subject, demographics and clinical characteristics (de- identified) will be entered into the biobank informatics system.