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It must be able to withstand repeated use. It must be primarily and customarily used to serve a medical purpose. It must be generally not useful to a person in the absence of an illness or injury. It must be appropriate for use in the home. All E codes fall under the jurisdiction of the DME MAC unless otherwise noted.
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Ordering Recommendation
Recommendations when to order or not order the test. May include related or preferred tests.Diagnostic confirmation for Huntington disease (HD) in a symptomatic individual. Presymptomatic testing for adults with a family history of HD.
Polymerase Chain Reaction/Fragment Analysis
Varies
Reported
Expected turnaround time for a result, beginning when ARUP has received the specimen.7-10 days after receipt of fully completed HD consent form
New York DOH Approval Status
Indicates test has been approved by the New York State Department of Health.Specimen Required
Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).
Transport 5 mL whole blood. (Min: 3 mL)
Refrigerated.
A completed HD specific consent form, signed by the patient (or legal guardian) and physician, is required for all specimens. Testing for patients under the age of 18 years or fetal specimens is not offered. Presymptomatic patients are strongly encouraged to be tested through a counseling program approved by the Huntington Disease Society of America at (800) 345-4372. Call Genetics Processing with additional questions at 800-242-2787 ext 3301.
Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.Negative: This individual has two normal alleles; and therefore, is neither a carrier nor will be affected with Huntington disease.
Interpretive Data
Background information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.Background Information for Huntington Disease (HD) Mutation by PCR:
Characteristics: Neurodegenerative disorder causing progressive cognitive, motor, and psychiatric disturbances typically beginning at 35-44 years of age
(Although, 5 percent are affected as juveniles and 25 percent affected after age 50).
Incidence: 1 in 15,000.
Inheritance: Autosomal dominant.
Cause: Expanded number of CAG repeats in the HD gene (27-35 repeats-unaffected, intermediate; 36-39 repeats-reduced penetrance; 40+ repeats-affected, full penetrance).
Clinical Sensitivity and Specificity: 99 percent.
Methodology: Chimeric PCR followed by size analysis using capillary electrophoresis.
Analytical Sensitivity and Specificity: 99 percent.
Limitations: Other neurodegenerative disorders will not be detected. Rare, previously unreported variants may interfere with PCR amplification. Diagnostic errors can occur due to rare sequence variations.
Counseling and informed consent are required for Huntington Disease genetic testing. Consent forms are available online at www.aruplab.com.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
| Phenotype | Number of CAG Repeats |
|---|---|
| Normal allele | Less than or equal to 26 |
| Mutable normal allele | 27-35 |
| HD allele with reduced penetrance | 36-39 |
| HD allele | Greater than or equal to 40 |
Laboratory Developed Test (LDT)
Hotline History
CPT Codes
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually.CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ.
CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 0050604 | Huntington Disease (HD) Allele 1 | 49637-2 |
| 0050606 | Huntington Disease (HD) Allele 2 | 49638-0 |
| 0050607 | Huntington Disease (HD) Interpretation | 50621-2 |
| 2001353 | Huntington Disease (HD) - Specimen | 31208-2 |
Aliases
Other names that describe the test. Synonyms.Ordering Recommendation
Recommendations when to order or not order the test. May include related or preferred tests.Diagnostic confirmation for Huntington disease (HD) in a symptomatic individual. Presymptomatic testing for adults with a family history of HD.
Polymerase Chain Reaction/Fragment Analysis
Varies
Reported
Expected turnaround time for a result, beginning when ARUP has received the specimen.7-10 days after receipt of fully completed HD consent form
New York DOH Approval Status
Indicates test has been approved by the New York State Department of Health.Specimen Required
Lavender (EDTA), pink (K2EDTA), or yellow (ACD Solution A or B).
Free Cpt Install Hd App
Transport 5 mL whole blood. (Min: 3 mL)
Refrigerated.
A completed HD specific consent form, signed by the patient (or legal guardian) and physician, is required for all specimens. Testing for patients under the age of 18 years or fetal specimens is not offered. Presymptomatic patients are strongly encouraged to be tested through a counseling program approved by the Huntington Disease Society of America at (800) 345-4372. Call Genetics Processing with additional questions at 800-242-2787 ext 3301.
Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month
Reference Interval
Normal range/expected value(s) for a specific disease state. May also include abnormal ranges.Free Cpt Install Hdmi
Negative: This individual has two normal alleles; and therefore, is neither a carrier nor will be affected with Huntington disease.
Interpretive Data
Background information for test. May include disease information, patient result explanation, recommendations, details of testing, associated diseases, explanation of possible patient results.Background Information for Huntington Disease (HD) Mutation by PCR:
Characteristics: Neurodegenerative disorder causing progressive cognitive, motor, and psychiatric disturbances typically beginning at 35-44 years of age
(Although, 5 percent are affected as juveniles and 25 percent affected after age 50).
Incidence: 1 in 15,000.
Inheritance: Autosomal dominant.
Cause: Expanded number of CAG repeats in the HD gene (27-35 repeats-unaffected, intermediate; 36-39 repeats-reduced penetrance; 40+ repeats-affected, full penetrance).
Clinical Sensitivity and Specificity: 99 percent.
Methodology: Chimeric PCR followed by size analysis using capillary electrophoresis.
Analytical Sensitivity and Specificity: 99 percent.
Limitations: Other neurodegenerative disorders will not be detected. Rare, previously unreported variants may interfere with PCR amplification. Diagnostic errors can occur due to rare sequence variations.
Counseling and informed consent are required for Huntington Disease genetic testing. Consent forms are available online at www.aruplab.com.
This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.
Counseling and informed consent are recommended for genetic testing. Consent forms are available online.
| Phenotype | Number of CAG Repeats |
|---|---|
| Normal allele | Less than or equal to 26 |
| Mutable normal allele | 27-35 |
| HD allele with reduced penetrance | 36-39 |
| HD allele | Greater than or equal to 40 |
Laboratory Developed Test (LDT)
Hotline History
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CPT Codes
Free Cpt Install Hd Digital
The American Medical Association Current Procedural Terminology (CPT) codes published in ARUP's Laboratory Test Directory are provided for informational purposes only. The codes reflect our interpretation of CPT coding requirements based upon AMA guidelines published annually.CPT codes are provided only as guidance to assist clients with billing. ARUP strongly recommends that clients confirm CPT codes with their Medicare administrative contractor, as requirements may differ.
CPT coding is the sole responsibility of the billing party. ARUP Laboratories assumes no responsibility for billing errors due to reliance on the CPT codes published.
| Component Test Code* | Component Chart Name | LOINC |
|---|---|---|
| 0050604 | Huntington Disease (HD) Allele 1 | 49637-2 |
| 0050606 | Huntington Disease (HD) Allele 2 | 49638-0 |
| 0050607 | Huntington Disease (HD) Interpretation | 50621-2 |
| 2001353 | Huntington Disease (HD) - Specimen | 31208-2 |