Test Details
Methodology
Illumina SNP Array
Result Turnaround Time
5 - 7 days
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
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 cgservices@labcorp.com.
Specimen Requirements
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.
Specimen
Whole blood; extracted DNA
Whole blood |
Whole blood; extracted DNA |
Volume
1 tube whole blood; 0.025 mL extracted DNA
|
1 tube whole blood; 0.025 mL extracted DNA |
Minimum Volume
1 tube whole blood; 0.025 mL extracted DNA
|
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)]
Lavender-top (EDTA) tube |
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)] |
Causes for Rejection
Wrong specimen container; mislabeled specimen
Collection Instructions
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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Footnotes
LOINC® Map
Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
---|---|---|---|---|---|---|
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125537 | APOE Genotyping Result: | 21619-2 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125539 | Additional Comments | 77202-0 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125538 | Limitations | 53097-9 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125547 | Methodology | 49549-9 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125549 | Background Information | 62364-5 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125553 | References | 75608-0 | |
125536 | APOE Alzheimer's Disease Risk | 21619-2 | 125554 | Result release: | 18771-6 | |
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125537 | |||||
Result Code Name | APOE Genotyping Result: | |||||
UofM | ||||||
Result LOINC | 21619-2 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125539 | |||||
Result Code Name | Additional Comments | |||||
UofM | ||||||
Result LOINC | 77202-0 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125538 | |||||
Result Code Name | Limitations | |||||
UofM | ||||||
Result LOINC | 53097-9 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125547 | |||||
Result Code Name | Methodology | |||||
UofM | ||||||
Result LOINC | 49549-9 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125549 | |||||
Result Code Name | Background Information | |||||
UofM | ||||||
Result LOINC | 62364-5 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125553 | |||||
Result Code Name | References | |||||
UofM | ||||||
Result LOINC | 75608-0 | |||||
Order Code | 125536 | |||||
Order Code Name | APOE Alzheimer's Disease Risk | |||||
Order Loinc | 21619-2 | |||||
Result Code | 125554 | |||||
Result Code Name | Result release: | |||||
UofM | ||||||
Result LOINC | 18771-6 |