National Dementia Diagnostics Laboratory

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-tau181), 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.

Elecsys^® quantitative immunoassays are used with National Association of Testing Authorities (NATA) accreditation. Values determined on samples by different assay methods may not be used interchangeably.

Plasma test for the exclusion of AD

Elecsys Phospho‑Tau (181P) Plasma is an in vitro quantitative immunoassay intended for the determination of the phosphorylated Tau 181 protein in human plasma.

The Elecsys Phospho‑Tau (181P) plasma assay result is intended to be used for the early detection of amyloid pathology in adult subjects aged 55‑80 years with subjective complaints or non-specific cognitive impairment (subjective cognitive decline) or whom their physician suspects of having mild cognitive impairment and who are being evaluated for Alzheimer’s disease and other causes of cognitive decline in primary, secondary, or tertiary care settings. A negative Elecsys Phospho‑Tau (181P) Plasma assay result indicates a high likelihood of having a negative amyloid positron emission tomography/cerebrospinal fluid result and, therefore, a low likelihood of having amyloid pathology. Investigation is recommended for other potential causes of cognitive impairment.

Limitations of use: The Elecsys Phospho‑Tau (181P) Plasma assay result must be considered as an aid in the diagnosis of Alzheimer’s disease in conjunction with other clinical information.

Plasma sample handling and transportation: Please refer to the Plasma specimen data sheet

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.

CJD testing specifications

Samples

• Must be accompanied by AD CSF Specimen Data Sheet (PDF, 303KB).
• Must be collected directly into the blue capped tube (Sarstedt 63.614.625), following the guidelines on page 2 of the AD CSF Specimen Data Sheet (PDF, 303KB).  DO NOT FREEZE the sample under any circumstance. CSF collected into any other tube type is considered unsuitable for Abeta1-42 only.
• 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 organising 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 AD CSF Specimen Data Sheet (PDF, 303KB) with details pertinent to the sample and invoice details. The sender must send an email to [email protected] notifying the tracking number.

The AD CSF, Neurofilament and Plasma Phospho-tau (181P) tests are performed weekly. Plasma pTau181P test is pending for NATA accreditation.

The 14-3-3 ELISA and RT-QuIC is performed weekly on a Monday.

Holiday period closures: NDDL is closed on the below days. Please hold all diagnostic samples for AD biomarker testing at 4° Celsius during affected periods.

• National and Victorian public holidays
• Christmas and New Year period: 25 December to early January
• Easter: Good Friday to the following Tuesday
• Melbourne Cup Carnival: Monday and Tuesday of the first week in November

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
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 sample reception at the loading dock is open from 8am-4pm. 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
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]