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EURORealTime APOE
| Test Code | D5137 |
|---|---|
| Test Summary |
This test aims to determine the ε2, ε3, and ε4 genotypes in the APOE gene by real-time PCR and provide the risk assessment and treatment of Alzheimer's disease. |
| Turn Around Time | 2 weeks |
| Acceptable Sample Types | Dried Blood Spots , Saliva , Whole Blood (EDTA) |
| NY Approved | No |
| Self (patient) Price | $350.00 |
| Institutional Price | $350.00 |
*TAT starts after the sample and all required sample information is received at the processing laboratory.
**The CPT codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association, and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.
**The CPT codes listed are in accordance with Current Procedural Terminology, a publication of the American Medical Association, and are provided for informational purposes only. CPT coding is the sole responsibility of the billing party.
This testing service has not been cleared or approved by the U.S. Food and Drug Administration. Testing services may not be licensed in accordance with the laws in all countries. The availability of specific test offerings is dependent upon laboratory location.
Test Code:
D5137
Test Description
Apolipoprotein E (ApoE) is a component of various lipoproteins such as VLDL, LDL and HDL to transport lipids in the blood and central nervous system (CNS). In the CNS, ApoE is mainly involved in nerve growth and regeneration. It binds amyloid-β peptides and plays a role in their degradation. Accumulation and deposition of amyloid-β peptides in CNS is known to be a molecular cause of Alzheimer's disease.
Three alleles of the APOE gene, ε2, ε3, and ε4, give rise to the major ApoE isoforms, which differ by 2 amino acids: ApoE2 contains Cys112/Cys158, ApoE3 Cys112/Arg158, and ApoE4 Arg112/Arg158. There are 3 homozygous phenotypes (E2/2, E3/3, E4/4) and 3 heterozygous (E2/3, E3/4, E2/4). The assay is based on PCR amplification and fluorescence-based real-time detection of defined sections within the APOE gene using specific primers and probes.
Three alleles of the APOE gene, ε2, ε3, and ε4, give rise to the major ApoE isoforms, which differ by 2 amino acids: ApoE2 contains Cys112/Cys158, ApoE3 Cys112/Arg158, and ApoE4 Arg112/Arg158. There are 3 homozygous phenotypes (E2/2, E3/3, E4/4) and 3 heterozygous (E2/3, E3/4, E2/4). The assay is based on PCR amplification and fluorescence-based real-time detection of defined sections within the APOE gene using specific primers and probes.
Indications for Testing
The EURORealTime APOE test provides qualitative molecular testing of the e2/e2, e2/e3, e3/e3, e2/e4, e3/e4 and e4/e4 genotypes in the APOE gene by real-time PCR. The product can be used as an aid in the proactive evaluation of risk factors for the anti-amyloid-beta (Aβ) antibody treatment in patients with Alzheimer's disease. The results should always be interpreted together with those of further laboratory diagnostic procedures and based on the clinical picture.
Genes
APOE
Test Methods and Limitations
Real-time PCR
Detailed Sample Requirements
Dried Blood Spots
| Collection Container(s) | Dried blood spot card |
|---|---|
| Collection | Follow kit instructions. Briefly, allow blood to saturate the card until indicated areas are filled and blood has soaked through the card. Air dry the card at ambient temperature for at least 3 hours.
|
| Sample Condition | Follow the instructions provided with the collection set. Store the dried blood at ambient temperature for up to two days. If the specimen cannot be sent as soon as it is dry, the filter paper should be placed in a sealable plastic bag and stored in a refrigerator (≤ 8°C) or preferably in a freezer. |
| Shipping | Follow kit instructions. Double bag and ship overnight at ambient temperature. |
Saliva
| Collection Container(s) | Oragene™ Saliva Collection Kit or ORAcollect-Dx kit |
|---|---|
| Collection | Collect saliva on an Oragene™ Saliva Collection Kit ORAcollect-Dx kit according to the manufacturer's instructions. |
| Sample Condition | Store at ambient temperature. Do not refrigerate or freeze. |
| Shipping | Ship overnight at ambient temperature. |
| Special Sample Instructions | Please contact Revvity Omics to request the saliva collection kit for patients who cannot provide a blood sample as whole blood is the preferred sample. Testing using Saliva swabs is currently not available for customers in India. Contact the Revvity Omics laboratory for more information. |
Whole Blood (EDTA)
| Collection Container(s) | EDTA (purple top) |
|---|---|
| Collection | Infants (< 2-years): 2 to 3 mL; Children (>2-years): 3 to 5 mL; Older children and adults: Minimum 5mL. The blood tube should be inverted several times immediately after blood collection to prevent coagulation. |
| Sample Condition | Store at ambient temperature. Do not refrigerate or freeze. |
| Shipping | Ship overnight at ambient temperature ensuring receipt within 5-days of collection. |
| Special Sample Instructions | Clotted or hemolyzed samples are not accepted. |