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Test ID ASYNC Alpha-Synuclein Protein Aggregates, Spinal Fluid


Specimen Required


Supplies: Sterile Specimen Tube, 6 mL (T485)

Container/Tube: Sterile polypropylene tube

Note: Polypropylene collection tubes must be used.

Specimen Volume: 1 mL

Collection Instructions:

1. Perform lumbar puncture and discard the first 1 to 2 mL of cerebrospinal fluid (CSF).

2. Collect CSF directly into a sterile polypropylene tube.

3. Inspect specimen for visible discoloration. Specimen must be clear and colorless to perform testing. Do not centrifuge.

4. Freeze sample upright prior to placing in transport container.


Useful For

Detection of pathogenic alpha-synuclein (alpha-synuclein aggregates) in adult patients being assessed for clinically uncertain cognitive decline or clinically uncertain parkinsonian syndromes

Highlights

The SAAmplify-aSYN test is a cerebrospinal fluid biomarker test that benefits adult patients exhibiting signs and symptoms of clinically uncertain cognitive decline or clinically uncertain parkinsonian syndromes, such as Parkinson disease, atypical parkinsonism, dementia with Lewy bodies, Alzheimer disease, mild cognitive impairment, and multiple system atrophy.

Method Name

Seed Amplification Assay (SAA)

Reporting Name

Alpha-Synuclein Aggregates, CSF

Specimen Type

CSF

Specimen Minimum Volume

0.3 mL

Specimen Stability Information

Specimen Type Temperature Time
CSF Frozen (preferred) 60 days
  Refrigerated  14 days

Reference Values

An interpretive report will be provided

Day(s) Performed

Varies

Report Available

15 to 18 days

Performing Laboratory

Amprion Inc.

Test Classification

This test was developed and its performance characteristics determined by Amprion, Inc. This test is used for clinical purposes. It should not be regarded as investigational or for research. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing.

CPT Code Information

0393U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ASYNC Alpha-Synuclein Aggregates, CSF Not Provided

 

Result ID Test Result Name Result LOINC Value
ASYNC Alpha-Synuclein Aggregates, CSF Not Provided

NY State Approved

No