Steps to Order the Elecsys® Alzheimer's Disease CSF Assays
Steps to Order the Elecsys AD CSF Assays
- Discuss ordering process/workflow with your local clinical laboratory partner
- In-house vs sendout
- Test code/EMR/diagnosis code/CPT code
- Reimbursement for Roche’s CSF test may be obtained using: 0445U (PLA code) to report the pTau181/AB42 ratio & 0459U for the tTau/AB42 ratio effective July 1, 2024. Prior to that, report 83520 x 2 (generic immunoassay CPT® code).
- Request the test package insert and any additional guidance from your lab partner
- Establish operational pathway for conducting lumbar punctures/collecting CSF samples
- Location
- Performing personnel and/or other specialties (i.e. interventional radiology)
- Patient education materials
- Establish sample collection protocols. As amyloid-beta is “sticky,” collection in a low-bind (polypropylene) tube is recommended in the Alzheimer’s Association International Guidance and the Elecsys CSF assays package inserts.
- Ensure availability of low-bind tube for CSF collection
- Tube type: 2.5 mL Low bind, False bottom tube (Sarstedt, 63.614.625). Polystyrene collection tubes are not acceptable as exposing of CSF to polystyrene tubes may decrease Abeta42 concentrations.
- Procedure and handling: The Alzheimer’s Association recommends a standardized protocol based on the drip collection method which reduces binding of Abeta42 to the syringe and instead allows for direct collecting into a low bind tube.
- Collect the sample following established protocol
- Ensure availability of low-bind tube for CSF collection
- Transport the sample to clinical lab/clinical lab partner following instructions. Samples are stable:
- At room temperature (5-25 C) for up to 5 days
- Refrigerated (2-8 C) for up to 14 days
- Frozen (-20 C) for up to 8 weeks with one freeze-thaw cycle
- At room temperature (5-25 C) for up to 5 days
- Evaluate results based on the validated cut-off and within the clinical context Elecsys AD CSF results will either be:
- Above cut-off = positive result, consistent with a positive amyloid PET scan result or
- Below cut-off = negative result, consistent with a negative amyloid PET scan result
The Elecsys pre-analytical protocol allows for reduction of variability between sites and improvement in the accuracy of biomarker measurements and inter-lab comparison5
Adherence to the pre-analytical protocol supports the implementation of CSF assays in routine clinical use.
Step 1
Perform the lumbar puncture (LP) using gravity drip collection method.
Step 2
Do not use the first 2 mL of CSF for Elecsys AD Biomarker measurement.
Step 3
Subsequently collect at least 2.5 mL of CSF directly into the CSF tube (2.5 mL Low bind False bottom tube).
Step 4
Do not process the CSF sample before transport to the measuring site (eg, no mixing/inverting, no tube transfers, no aliquoting, no freezing, and normally no centrifugation) until measurement.
Step 5
Transport the samples to the measuring site (laboratory), where the sample is placed directly on the cobas e system for measurement.5
The CSF sample can be analyzed immediately after collection by directly placing the tube with false bottom CSF, 2.5 mL onto the analyzer. If storage and/or transport is necessary, samples can be transported/stored according to the graphic above.
*Additional material required for CSF collection (but not available through Roche):
Product: 2.5 mL Low bind False bottom tube
Order Number: 63.614.625
Vendor: Sarstedt
References
- Elecsys Method Sheets: ms_08846634501; ms_08821909501; ms_08846715501; ms_08846693501; ms_08821941501.
- Cummings, J., Apostolova, L., Rabinovici, G.D. et al. Lecanemab: Appropriate Use Recommendations. J Prev Alzheimers Dis 10, 362–377 (2023).
- Hansson O. et al. Alzheimer's Dement. 2018; 14[11]:1470-1481.
- Hansson O, et al., Alzheimer’s Dement.2021;17:1575–1582.
- Hansson O, et al. Alzheimers Dement. 2020;12:e12137.