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Test Code LAB5799 PrecivityAD2, Plasma

Important Note

GOES LIVE 5/6, ORDER MISCLM IF ORDERED BEFORE GO LIVE DATE.

Additional Codes

SQ:C2AD2M


Ordering Guidance


This blood test is intended for use in patients aged 50 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.


Secondary ID

621652

Useful For

Assisting in the evaluation of adult patients, aged 50 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 50 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.

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
Plasma Frozen

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject
Outside of age range
Specimen collected outside of testing range (too long in storage before arrival to testing facility)
Insufficient volume
Incorrect labeling
Reject

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

Method Description

Plasma specimens undergo immunoprecipitation followed by liquid chromatography tandem mass spectrometry (LC-MS/MS) for the quantification of amyloid beta (Abeta) 42 and Abeta 40 peptide isoform concentrations and phosphorylated and non-phosphorylated tau at amino acid threonine, position 217 (p-tau271 and np-tau217) peptide concentrations. The percent tau phosphorylated at threonine-217 (%p-tau217) is calculated using the following equation: p-tau271/np-tau217*100. A statistical algorithm combines the Abeta42/40 and %p-tau217 to generate the Amyloid Probability Score 2 (APS2).(Meyer MR, Kirmess KM, Eastwood S, et al. Clinical validation of the PrecivityAD2 blood test: A mass spectrometry-based test with algorithm combining %p-tau217 and Abeta42/40 ratio to identify presence of brain amyloid. Alzheimers Dement.2024;20[5]:3179-3192. doi:10.1002/alz.13764)

Day(s) Performed

Monday through Friday

Report Available

13 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