ADmark® ApoE Genotype Analysis and Interpretation (Symptomatic)

Test Code
10642


CPT Codes
81401

Physician Attestation of Informed Consent
This germline genetic test requires physician attestation that patient consent has been received if ordering medical facility is located in AK, DE, FL, GA, IA, MA, MN, NV, NJ, NY, OR, SD or VT or test is performed in MA.


Includes
ADmark ApoE Genotype Analysis and Interpretation and is useful to detect ApoE2, E3, and E4 alleles. ADmark assays should only be ordered for patients with symptoms of dementia and are not appropriate for asymptomatic individuals.


Preferred Specimen
8 mL whole blood collected in an EDTA (lavender-top) tube


Minimum Volume
6 mL


Instructions
Stability Restrictions: Specimens (and signed informed consent form) must arrive at Chantilly Monday through Thursday within 24 hours of collection. Do not submit on a day before a holiday. Do not freeze whole blood specimens.

Sample must be noted as "symptomatic" and patient must be 18 years or older. Samples not noted as "symptomatic" and samples for patients under 18 years of age will be rejected by Athena.

Higher blood volumes ensure adequate DNA quantity, which varies with WBC, specimen condition, and need for confirmatory testing.

DNA yields and quality are better in fresh specimens. However, when necessary, most genetic tests are successful from DNA purified from whole blood that is several days old. Immediate shipping is recommended to optimize DNA quality and quantity.

Please note: Athena does not perform ApoE testing for individuals under the age of 18. Pre-test and post-test genetic counseling is strongly recommended.


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 10 days
Refrigerated: 10 days
Frozen: 90 days


Methodology
Restriction Fragment Length Polymorphism (RFLP)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Athena Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Varies; Report available: 7-14 days


Reference Range
See Laboratory Report


Clinical Significance
Detection of APOE2, E3, E4 alleles.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.