Ordering Recommendations

Evaluation of individuals, aged 50 years and older, presenting with cognitive impairment who are being assessed for Alzheimer disease and other causes of cognitive decline
 
This test is not intended as a screening test for Alzheimer disease in asymptomatic individuals.
 

Collect

Lavender top (EDTA)

Specimen Preparation

Centrifuge and aliquot 0.6 mL plasma into plastic vial. Do not submit in original tube.

Storage/Transport Temperature

Store refrigerated/Ship refrigerated

Unacceptable Conditions

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Stability (from collection to initiation)

Temperature Time
Refrigerated (preferred) 7 days
Frozen 7 days
Ambient 72 hours

Minimum Requirements

0.5 mL

Lab Section

Send-out lab

Performing Lab

Mayo Clinic Laboratories

Methodology

Chemiluminescent Enzyme Immunoassay

Performed

Tuesday, Thursday

Reported

1 to 5 days

Synonyms

  • pTau217
  • PhosphoTau217
  • Alzheimer Disease

Reference Lab Number

PT217

Performing Laboratory Website (click below)

https://www.mayocliniclabs.com/

Reference Interval

Negative: < or =0.185 pg/mL
Intermediate: 0.186-0.324 pg/mL
Positive: > or =0.325 pg/mL
 

Interpretive Data

Negative: A normal (negative) phosphorylated Tau217 (p-Tau217) result is consistent with a negative (normal) amyloid-positron emission tomography (PET) scan result. This result indicates a reduced likelihood that an individual has neuropathological changes associated with Alzheimer disease.
 
Intermediate: An intermediate p-Tau217 result cannot accurately differentiate between the presence or absence of neuropathological changes associated with Alzheimer disease. Further testing, such as amyloid-positron emission tomography (PET) or cerebrospinal fluid Abeta42 and tau biomarkers, is needed to determine the likelihood of neuropathological changes associated with Alzheimer disease being present.
 
Positive: An elevated (positive) p-Tau217 result is consistent with a positive (abnormal) amyloid-positron emission tomography (PET) scan result. This result is consistent with the presence of neuropathological changes associated with Alzheimer disease. In the proper clinical context this test is supportive of Alzheimer disease being related to current clinical symptoms. This test has not been demonstrated to provide information on the risk of an asymptomatic individual developing symptoms related to Alzheimer disease in the future.
 
Clinical performance of this test was established in a study of 427 individuals aged 50 years and older with mild cognitive impairment or early dementia with a 64% prevalence of amyloid pathology defined by an amyloid-PET and a Centiloid scale value of 25 or more. For detection of an abnormal amyloid-PET, pTau217 test sensitivity at the lower cutpoint (< or =0.185 pg/mL) was 92% and the specificity at the upper cutpoint (> or =0.325 pg/mL) was 96%. The diagnostic performance of this test has not been established in asymptomatic individuals.

 

Cautions 
 
Phosphorylated Tau217 (p-Tau217) results must be interpreted in conjunction with other diagnostic tools, such as neurological examination, neurobehavioral tests, imaging, and routine laboratory tests.
 
This assay should not be ordered for individuals younger than 50 years.
 
Elevations of p-Tau217 may be seen in individuals with impaired kidney function associated with chronic kidney disease and should be interpreted with caution in these situations.
 
False-positive or false-negative test results may occur.
 
The performance of this test was evaluated using specimens obtained from a US White population. At this time, it is uncertain if similar clinical performance will be observed in other racial and ethnic groups.
 
This assay should not be used for cognitively unimpaired (asymptomatic) individuals to predict the development of dementia or other neurological conditions.
 
The safety and effectiveness of this test have not been established for monitoring the effect of disease monitoring therapies or for predicting development of dementia or other neurologic conditions.
 
p-Tau217 concentrations have not been established to correlate with disease severity.
 
Results obtained with different assay methods or kits may be different and cannot be used interchangeably.
 
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies or heterophile antibodies) that may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.

CPT Codes

83520

LOINC Mapping

Test Id Test Order Name Order LOINC Value
PT217 Phospho-Tau(217), P 104663-0
Result Id Test Result Name Result LOINC Value 
217PT pTau217, P 104663-0
PTINT pTau217 Interpretation 69048-7

Order Type (Individual or Group)

G

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric)
217PT Y pTAU 217 I Alphanumeric
PTINT Y pTAU 217 Interpretation I Alphanumeric

CPT Codes

83520

LOINC Mapping

Test Id Test Order Name Order LOINC Value
PT217 Phospho-Tau(217), P 104663-0
Result Id Test Result Name Result LOINC Value 
217PT pTau217, P 104663-0
PTINT pTau217 Interpretation 69048-7

Pricing

Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu
Specimen Requirements

Ordering Recommendations

Evaluation of individuals, aged 50 years and older, presenting with cognitive impairment who are being assessed for Alzheimer disease and other causes of cognitive decline
 
This test is not intended as a screening test for Alzheimer disease in asymptomatic individuals.
 

Collect

Lavender top (EDTA)

Specimen Preparation

Centrifuge and aliquot 0.6 mL plasma into plastic vial. Do not submit in original tube.

Storage/Transport Temperature

Store refrigerated/Ship refrigerated

Unacceptable Conditions

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Stability (from collection to initiation)

Temperature Time
Refrigerated (preferred) 7 days
Frozen 7 days
Ambient 72 hours

Minimum Requirements

0.5 mL
Testing

Lab Section

Send-out lab

Performing Lab

Mayo Clinic Laboratories

Methodology

Chemiluminescent Enzyme Immunoassay

Performed

Tuesday, Thursday

Reported

1 to 5 days

Synonyms

  • pTau217
  • PhosphoTau217
  • Alzheimer Disease

Reference Lab Number

PT217

Performing Laboratory Website (click below)

https://www.mayocliniclabs.com/
Result Interpretation

Reference Interval

Negative: < or =0.185 pg/mL
Intermediate: 0.186-0.324 pg/mL
Positive: > or =0.325 pg/mL
 

Interpretive Data

Negative: A normal (negative) phosphorylated Tau217 (p-Tau217) result is consistent with a negative (normal) amyloid-positron emission tomography (PET) scan result. This result indicates a reduced likelihood that an individual has neuropathological changes associated with Alzheimer disease.
 
Intermediate: An intermediate p-Tau217 result cannot accurately differentiate between the presence or absence of neuropathological changes associated with Alzheimer disease. Further testing, such as amyloid-positron emission tomography (PET) or cerebrospinal fluid Abeta42 and tau biomarkers, is needed to determine the likelihood of neuropathological changes associated with Alzheimer disease being present.
 
Positive: An elevated (positive) p-Tau217 result is consistent with a positive (abnormal) amyloid-positron emission tomography (PET) scan result. This result is consistent with the presence of neuropathological changes associated with Alzheimer disease. In the proper clinical context this test is supportive of Alzheimer disease being related to current clinical symptoms. This test has not been demonstrated to provide information on the risk of an asymptomatic individual developing symptoms related to Alzheimer disease in the future.
 
Clinical performance of this test was established in a study of 427 individuals aged 50 years and older with mild cognitive impairment or early dementia with a 64% prevalence of amyloid pathology defined by an amyloid-PET and a Centiloid scale value of 25 or more. For detection of an abnormal amyloid-PET, pTau217 test sensitivity at the lower cutpoint (< or =0.185 pg/mL) was 92% and the specificity at the upper cutpoint (> or =0.325 pg/mL) was 96%. The diagnostic performance of this test has not been established in asymptomatic individuals.

 

Cautions 
 
Phosphorylated Tau217 (p-Tau217) results must be interpreted in conjunction with other diagnostic tools, such as neurological examination, neurobehavioral tests, imaging, and routine laboratory tests.
 
This assay should not be ordered for individuals younger than 50 years.
 
Elevations of p-Tau217 may be seen in individuals with impaired kidney function associated with chronic kidney disease and should be interpreted with caution in these situations.
 
False-positive or false-negative test results may occur.
 
The performance of this test was evaluated using specimens obtained from a US White population. At this time, it is uncertain if similar clinical performance will be observed in other racial and ethnic groups.
 
This assay should not be used for cognitively unimpaired (asymptomatic) individuals to predict the development of dementia or other neurological conditions.
 
The safety and effectiveness of this test have not been established for monitoring the effect of disease monitoring therapies or for predicting development of dementia or other neurologic conditions.
 
p-Tau217 concentrations have not been established to correlate with disease severity.
 
Results obtained with different assay methods or kits may be different and cannot be used interchangeably.
 
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies or heterophile antibodies) that may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Coding

CPT Codes

83520

LOINC Mapping

Test Id Test Order Name Order LOINC Value
PT217 Phospho-Tau(217), P 104663-0
Result Id Test Result Name Result LOINC Value 
217PT pTau217, P 104663-0
PTINT pTau217 Interpretation 69048-7
URM Labs Internal
Test Build

Order Type (Individual or Group)

G

Group Test Information

Result Test ID Reportable Result Test Name Result Type Type (Alpha or Numeric)
217PT Y pTAU 217 I Alphanumeric
PTINT Y pTAU 217 Interpretation I Alphanumeric

CPT Codes

83520

LOINC Mapping

Test Id Test Order Name Order LOINC Value
PT217 Phospho-Tau(217), P 104663-0
Result Id Test Result Name Result LOINC Value 
217PT pTau217, P 104663-0
PTINT pTau217 Interpretation 69048-7

Pricing

Refer to Lab Account Manager. email: labservicesoutreach@urmc.rochester.edu

Important Information

Lab Section
Send-out lab
Restricted Test Information
RESTRICTED TEST: This test is restricted to board-certified, subspecialty trained physicians with Staff Privileges at Strong Memorial Hospital, Highland Hospital or F.F. Thompson Hospital. For exceptions: Please refer to the LDC Appeal Process.

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