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Test ID C2NAD PrecivityAD, Plasma


Ordering Guidance


This blood test is intended for use in patients aged 55 and older with signs or symptoms of mild cognitive impairment or dementia who are undergoing evaluation for Alzheimer disease or other forms of cognitive decline.



Shipping Instructions


1. Specimen should be shipped frozen on dry ice

2. Place labeled aliquot tube inside a larger tube or vial for transport.



Specimen Required


Supplies: Screw cap micro tube, 2 mL, PCR Performance Tested, Low protein-binding (T983)

Collection Container/Tube: 10 mL Purple top (K EDTA)

Submission Container/Tube: 2-mL screw cap micro tubes

Specimen Volume: 1.5 mL

Collection Instructions:

1. Centrifuge within two hours of collection.

2. Aliquot plasma into a 2 mL micro tube.

3. Freeze plasma (no longer than 2 hours after collection) at -20° C or below.


Useful For

Assisting in the evaluation of adult patients, aged 55 years and older, with signs or symptoms of mild cognitive impairment or dementia who are being assessed for Alzheimer disease and other causes of cognitive decline

 

This is not intended for patients younger than 55 years, or for use as a screening test in patients without signs or symptoms of cognitive impairment, or for serial testing for assessment of longitudinal changes.

Highlights

The PrecivityAD test identifies whether a patient with signs or symptoms of cognitive decline is likely to have amyloid plaques in the brain, a pathological hallmark of Alzheimer disease.

 

This blood test measures amyloid beta (Abeta) 42/40 ratio and apolipoprotein E isoforms E2, E3, and E4. Individual Abeta42 and Abeta40 concentrations are not reported.

Method Name

Immunoprecipitation/Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

PrecivityAD

Specimen Type

Plasma

Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma Frozen

Reference Values

Amyloid Probability Score (APS): 0-100

Low (0-35): Consistent with absence of amyloid plaques

Intermediate (36-57)

High (58- 100): Consistent with presence of amyloid plaques

 

Abeta42/40 Ratio

≥0.095: Consistent with absence of amyloid plaques

 

ApoE Proteotype

E2/E2, E2/E3, E2/E4, E3/E3, E3/E4, E4/E4

-E3 is the most common allele.

-E4 allele is associated with increased risk of amyloid plaques.

-E2 allele is associated with lower risk of amyloid plaques.

Day(s) Performed

Monday through Friday

Report Available

10 days post sample receipt from MCL.

Performing Laboratory

C2N Diagnostics LLC

Test Classification

C2N Diagnostics has developed and determined the analytical and clinical validity performance characteristics of this Laboratory Developed Test (LDT). This assay has been validated pursuant to CLIA regulations and is used for clinical purposes. This assay has not been cleared or approved by the FDA.

CPT Code Information

0412U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
C2NAD PrecivityAD Not Provided

 

Result ID Test Result Name Result LOINC Value
ND2B Amyloid Probability Score (APS) Not Provided
ND2BF APS Result Not Provided
ND2C Interpretation Not Provided
ND2D APS Reference Interval Not Provided
ND2E Patient Age Not Provided
ND2F Abeta42/40 Ratio Not Provided
ND2G Abeta42/40 Ratio Reference Interval Not Provided
ND2H Abeta42/40 Ratio Description Not Provided
ND2I ApoE Proteotype Not Provided
ND2J ApoE Proteotype Reference Interval Not Provided
ND2K Test Description Not Provided
ND2L Limitations of Test Result Not Provided
ND2M Methods and Assay Category Not Provided
ND2N References Not Provided
ND2O Report Comment Not Provided
ND2P Performing Site Not Provided

NY State Approved

No