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Test Id : ASYNC

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Alpha-Synuclein Protein Aggregates, Spinal Fluid

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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
A short description of the method used to perform the test

Seed Amplification Assay (SAA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

No

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Alpha-Synuclein Aggregates, CSF

Aliases
Lists additional common names for a test, as an aid in searching

Parkinson disease

PD

Dementia with Lewy bodies

DLB

Lewy body disease

LBDCSF

Alzheimer disease

AD

Mild cognitive impairment

MCI

Multiple system atrophy

MSA

RT-QuIC

SAA

Seed Amplification Assay

SNYTap

Synucleinopathy

ZW336

AMP1200

SAAmplify-aSYN (CSF)

Specimen Type
Describes the specimen type validated for testing

CSF

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Forms

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.3 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis Reject
Icterus Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Synucleinopathies are a family of neurodegenerative disorders diagnosed pathologically based on the presence of inclusions composed of aggregates of misfolded alpha-synuclein protein in the brain. Synucleinopathies are divided into two major subgroups: Lewy body disease (LBD) and multiple system atrophy (MSA). LBD is characterized by deposits of aggregated alpha-synuclein that develop in neurons (Lewy bodies or Lewy neurites); LBDs include Parkinson disease, dementia with Lewy bodies, and Parkinson disease dementia. MSA is characterized by deposits of aggregated alpha-synuclein that develop in oligodendrocytes (called glial cytoplasmic inclusions). Synuclein pathology is often also present as a co-pathology in other neurodegenerative disorders, including Alzheimer disease and mixed dementias. Therefore, the presence or absence of synuclein pathology is an important factor influencing diagnosis and disease course across a spectrum of motor and cognitive neurodegenerative disorders.

 

Historically, synucleinopathies have been diagnosed during life based on clinical symptoms, sometimes augmented by dopamine transporter single-photon emission computed tomography imaging, with definitive diagnosis only possible through identification of synuclein aggregates in the brain at autopsy. The alpha-synuclein seed amplification assay detects aggregates of alpha-synuclein in cerebrospinal fluid (CSF). Studies have shown that detection of alpha-synuclein aggregates in CSF during life by SAA correlates with high sensitivity and specificity to the presence of synuclein pathology identified in the brain at autopsy.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

An interpretive report will be provided

Interpretation
Provides information to assist in interpretation of the test results

Detection of alpha-synuclein aggregates in cerebrospinal fluid is consistent with the presence of a synucleinopathy (eg, Parkinson disease, dementia with Lewy bodies, Alzheimer disease with Lewy body pathology, and multiple system atrophy).

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Results must be interpreted in conjunction with other patient clinical information.

 

The alpha-synuclein (aSyn) protein test utilizes fluorescence to detect increases in aSyn aggregate formation. Validation studies have determined that certain substances such as blood, hemoglobin, and conjugated bilirubin may affect results at concentrations where visible discoloration is evident in the CSF. The laboratory will evaluate all specimens submitted for suitability for testing. Sensitivity for detection of alpha-synuclein aggregates with a Detected-2 profile is low; therefore, results should be interpreted with caution for the purposes of rule in/rule out multiple system atrophy.

 

This test is for professional use only.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Rizzo G, Copetti M, Arcuti S, Martino D, Fontana A, Logroscino G. Accuracy of clinical diagnosis of Parkinson disease: A systematic review and meta-analysis. Neurology. 2016;86(6):566-576. doi:10.1212/WNL.0000000000002350

2. Rizzo G, Arcuti S, Copetti M, et al. Accuracy of clinical diagnosis of dementia with Lewy bodies: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2018;89(4):358-366. doi:10.1136/jnnp-2017-316844

3. Wenning GK, Stankovic I, Vignatelli L, et al. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022;37(6):1131-1148. doi:10.1002/mds.29005

Method Description
Describes how the test is performed and provides a method-specific reference

This test is a seed amplification assay (SAA). The novel SAA strategy essentially mimics the biological process in which in vivo protein misfolding and aggregation follows a seeding/nucleation mechanism. Briefly, CSF samples are incubated with an excess of monomeric human recombinant (rec) alpha Syn (aSyn) and subjected to intermittent shaking/incubation cycles. If soluble misfolded aSyn aggregates are present in the sample, these aggregates are amplified using rec-aSyn as substrate. aSyn aggregates formed in the reaction are detected as an increase in fluorescence due to the presence of the amyloid-specific binding dye, thioflavin T. In the absence of aSyn seeds, fluorescence remains below the validated assay cutoff.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

Referral

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Varies

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

15 to 18 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Amprion Inc.

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

0393U

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ASYNC Alpha-Synuclein Aggregates, CSF Not Provided
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
ASYNC Alpha-Synuclein Aggregates, CSF Not Provided

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2025-03-25