Special Instructions
This test is not approved for use in New York state.
If you have questions, please call Consumer Genetics (CG) customer service at 336-436-7089 for assistance or email [email protected].
Expected Turnaround Time
5 - 7 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Whole blood; extracted DNA
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Whole blood |
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Whole blood; extracted DNA |
Volume
1 tube whole blood; 0.025 mL extracted DNA
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1 tube whole blood; 0.025 mL extracted DNA |
Minimum Volume
1 tube whole blood; 0.025 mL extracted DNA
Container
Lavender-top (EDTA) tube (preferred), yellow-top (ACD) tube or green-top (heparin) tube; extracted DNA: DNA extracted in a CLIA certified lab [all extracted DNA samples will be processed and quantified upon receipt in order to evaluate for sufficient DNA quantity (minimum 15 ng/µl needed for assay after quantification)]
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Lavender-top (EDTA) tube |
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Lavender-top (EDTA) tube (preferred), yellow-top (ACD) tube or green-top (heparin) tube; extracted DNA: DNA extracted in a CLIA certified lab [all extracted DNA samples will be processed and quantified upon receipt in order to evaluate for sufficient DNA quantity (minimum 15 ng/µl needed for assay after quantification)] |
Collection
Invert tube immediately eight to 10 times once tube is filled at time of collection.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 3 days (whole blood and extracted DNA) |
| Refrigerated | 60 days (whole blood); 7 days (extracted DNA) |
| Frozen | 90 days (extracted DNA) |
| Freeze/thaw cycles | Stable x2 (extracted DNA) |
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Causes for Rejection
Wrong specimen container; mislabeled specimen
Test Details
Use
Alzheimer's disease is a progressive neurodegenerative disorder that affects more than 6.7 million Americans ages 65 and older and is the most common form of dementia in the elderly. Signs and symptoms may include cognitive decline, memory loss, loss of problem-solving skills and personality changes. Clinical symptoms appear after 60-65 years in 95% of cases. The development of late-onset disease may be influenced by age, sex, family history, level of education, history of head trauma and other factors including cardiovascular risk factors. Approximately 15-20% of late-onset disease may be familial. The APOE gene is a known susceptibility gene for Alzheimer's disease. The APOE gene encodes apolipoprotein E, which has a role in lipid metabolism. APOE has three common alleles: E2, E3 and E4. The presence of the E4 allele increases the lifetime risk of Alzheimer's disease but is neither necessary nor sufficient for the development of Alzheimer's disease. APOE E2 may have some protective effect against development of late-onset disease.1 APOE also has a rate allele: E1 (legacy name E3r). There is insufficient evidence to assess the clinical association of APOE E1 with Alzheimer's disease.2
Limitations
APOE E2, E3 and E4 are validated for this analysis. The rare APOE E1/E1, E1/E2 and E1/E3 genotypes are reported as failed results. E2/E4 and E1/E3 genotypes cannot be distinguished by this assay. Molecular-based testing is highly accurate, but as in any laboratory test, rare errors may occur. False positive or false negative results may occur for reasons that include genetic variants, blood transfusions, bone marrow transplantation, somatic or tissue-specific mosaicism, mislabeled samples or erroneous representation of family relationships. This test was developed and its performance characteristics determined by Labcorp.
Methodology
Illumina SNP Array
Footnotes
1. Goldman JS, Hahn SE, Catania JW, et al. Genetic counseling and testing for Alzheimer disease: joint practice guidelines of the American College of Medical Genetics and the National Society of Genetic Counselors. Genet Med. 2011 Jun;13(6):597-605.21577118
2. Murrell JR, Price BM, Baiyewu O, et al. The fourth apolipoprotein E haplotype found in the Yoruba of Ibadan. Am J Med Genet B Neuropsychiatr Genet. 2006 Jun 5;141B(4):426-427.16583434
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