National Dementia Diagnostics Laboratory
The National Dementia Diagnostics Laboratory (NDDL), located at The Florey, is a NATA/ILAC accredited pathology testing laboratory.
The NDDL is the only accredited pathology testing laboratory in Australia that provides cerebrospinal fluid (CSF) diagnostic testing for Alzheimer’s disease (AD) and Creutzfeldt-Jakob disease (CJD).
The NDDL provides diagnostic services to the medical community, scientific researchers and the pharmaceutical industry and is a collaboration between The Florey and the University of Melbourne.
CSF test for AD
The Cerebrospinal Fluid (CSF) Assay for Alzheimer’s Disease (AD) is an ante-mortem diagnostic test that detects alterations in biomarker protein levels, Abeta1-42, phospho-tau (P-tau), and total Tau (T-tau) in fresh CSF, which are reported to be directly related to the pathophysiology of the disease. These CSF biomarkers offer ~90% sensitivity and specificity for early diagnosis of Alzheimer’s disease.
Neurofilament Light
Neurofilament light chain (NfL) is a non-specific biomarker of central nervous system neuronal injury. It is used together with clinical correlation and is seeking NATA accreditation.
CSF tests for CJD
These tests include the National Association of Testing Authorities (NATA) accredited CJD biomarker panel ( 14-3-3 ELISA and RT-QuIC assay).
As CSF 14-3-3 and total-tau proteins provide similar sensitivity and specificity for the diagnosis of CJD, from 1 June 2024 CSF total-tau measurement is no longer included as part of the CJD CSF biomarker panel.
Samples
- Must be accompanied by the CSF Specimen Data Sheet (PDF, 336KB).
- Must be collected directly into the blue capped tube (Sarstedt 63.614.625), following the guidelines on the CSF Specimen Data Sheet (PDF, 336KB). DO NOT FREEZE the sample under any circumstance. CSF collected into any other tube type is considered unsuitable for Abeta1-42.
- CSF in the blue capped tube is also suitable for NfL and CJD biomarker testing.
Samples transportation
- A pathology laboratory that is referring a CSF sample for testing is responsible for organizing a courier service to collect and deliver the sample with cool pack (not frozen) to NDDL.
- If the CSF specimen is collected in a private imaging facility/theatre and is being forwarded directly to the NDDL for testing and not via a pathology laboratory, the collecting facility is responsible to send the specimen secured in double specimen bags with padding to NDDL, using overnight express service such as prepaid Australian Post, which has a tracking number.
- Each CSF sample must be accompanied by a signed copy of the doctor’s request and a completed CSF Specimen Data Sheet (PDF, 336KB) with details pertinent to the sample and invoice details. The sender must send an email to [email protected] notifying the tracking number.
Testing fees
There is currently no Medicare rebate for the NDDL AD Biomarker testing. For private patients, a signed payment agreement for the test on the request form is required.
The Alzheimer’s disease biomarker test includes Abeta1-42, P-tau and T-tau and the cost is $400 (effective from July 2023).
The cost for the Neurofilament Light chain testing is $200.
CJD Biomarker testing for domestic samples incurs no fee. International samples incur a fee of $AUD 500.00.
Testing schedule
The AD test is performed weekly. Neurofilament light is 1–2 weeks.
The 14-3-3 ELISA is performed weekly on a Monday and the RT-QuIC is performed weekly on a Thursday.
Clinician resources
Australian-registered healthcare professionals can visit the ADBioHub to access educational resources including:
- Podcast: Explore biomarker testing for Alzheimer’s disease
- Podcast: Unravel the neuropathology of Alzheimer’s disease
In May 2024, Roche hosted a series of educational evenings around Australia to shine a spotlight on the changing landscape of Alzheimer’s disease in Australia. Several Australian Alzheimer’s disease experts shared the latest information on the importance of early and accurate diagnosis, upcoming treatments and Australia’s readiness for their arrival. Visit the Roche website to access the recordings.
Find out more about CJD testing at the Australian National CJD Registry.
Contact
NDDL – AD Biomarker Test
E [email protected]
P +61 3 9035 7243
F +61 3 9349 5105
CJD Biomarker Test
E [email protected]
P +61 3 8344 1949 (8am–4pm, Monday – Friday)
F +61 3 9349 5105
Delivery
Attn: NDDL-AD and/or ANCJDR
National Dementia Diagnostics Laboratory
The Florey
Kenneth Myer Building
30 Royal Parade (corner of Genetics Lane)
Enter via Gate 11, rear loading dock
Parkville Victoria 3010
The NDDL is closed on public holidays. Please hold all diagnostic samples for AD biomarker testing at 4 degrees Celsius during affected periods. CJD diagnostic samples should be stored frozen during closure periods. Contact the relevant testing group for further information.
NDDL management
Professor Steven Collins – Director/Designated person
Professor Colin Masters – Delegated Medical Specialist
Associate Professor Qiao-Xin Li – Co-Manager AD
Dr Christiane Stehmann – Co-Manager CJD
Dr Ian Birchall – Quality Manager
Ms Shannon Sarros – Quality Manager
Research and postdoctoral fellows
Dr Vicki Lewis –Research Scientist
Dr Matteo Senesi – Research Scientist
Research and technical staff
Ms Amelia McGlade – Research Assistant CJD
Ms Shiji Varghese – Research Assistant AD
Ms Priscilla Agustina – Research Assistant CJD
Complaints
Complaints about the NDDL operations can be forwarded to the NDDL Directors, Professor Steven Collins and/or Professor Colin Masters.
Complaints related to the NDDL research specific operations or potential breaches of ethical responsibilities can be forwarded to the University of Melbourne’s Human Research Ethics Committee:
Manager
Human Research Ethics Office for Research Ethics and Integrity
The University of Melbourne VIC 3010
T 03 8344 2073
E [email protected]
