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Test ID C2AD2 PrecivityAD2, 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. Specimens must be shipped frozen on dry ice.

2. Place labeled aliquot tubes 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: Two 2-mL screw cap micro tubes

Specimen Volume: 3 mL in 2 tubes, each containing 1.5 mL

Collection Instructions:

1. Centrifuge within two hours of collection.

2. Label two 2-mL screw-cap micro tubes.

3. Aliquot 1.5 mL of plasma into each labeled micro tube.

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


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 PrecivityAD2 blood test measures amyloid beta (Abeta) 42/40 ratio and percent tau phosphorylated at threonine-217 (%p-tau217). The results are then combined and used in a proprietary statistical algorithm to calculate the Amyloid Probability Score 2 (APS2). The APS2, Abeta 42/40 ratio and %p-tau217 are reported, however, individual Abeta42, Abeta40, phosphorylated tau217 and non-phosphorylated tau217 concentrations are not reported.

Method Name

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

Reporting Name

PrecivityAD2

Specimen Type

Plasma

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Plasma Frozen

Reference Values

Amyloid Probability Score 2 (APS2) (range of 0-100):

Negative: 0-47

Positive: 48-100

 

Abeta42/40 Ratio:

≥0.095 Consistent with absence of amyloid plaques

 

Percent p-tau217:

<4.2% consistent with absence of brain 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

0503U

LOINC Code Information

Test ID Test Order Name Order LOINC Value
C2AD2 PrecivityAD2 Not Provided

 

Result ID Test Result Name Result LOINC Value
AD2C Amyloid Probability Score 2 (APS2) Not Provided
AD2CF APS2 Result Not Provided
AD2D APS2 Result Interpretation Not Provided
AD2E APS2 Result Reference Interval Not Provided
AD2F APS2 Description Not Provided
AD2G Percent p-tau217 Not Provided
AD2H Percent p-tau217 Reference Interval Not Provided
AD2HD Percent p-tau217 Description Not Provided
AD2I Abeta42/40 Ratio Not Provided
AD2J Abeta42/40 Ratio Reference Interval Not Provided
AD2JD Abeta42/40 Ratio Description Not Provided
AD2K Test Description Not Provided
AD2L Limitations of Test Result Not Provided
AD2M Methods and Assay Category Not Provided
AD2N References Not Provided
AD2O Report Comment Not Provided
AD2P Performing Site Not Provided

NY State Approved

No