CKR-5 Gene, DNA Mutation Analysis (38956X)

Test Code

83485N

CPT Codes
81400<br />

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.

Preferred Specimen

5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume

3 mL

Other Acceptable Specimens

ACD solution B (yellow-top) • EDTA (royal blue-top) • Sodium heparin (green-top)

Instructions

Whole blood: Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Call laboratory if blood samples received frozen

Methodology
Polymerase Chain Reaction (PCR) • Single Nucleotide Primer Extension

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

Setup Schedule

Set up: Wed, Sat; Report available: 5 days

Limitations

This analysis detects only the 32-bp deletion and cannot detect other mutations in the CCR5 gene, or other genetic or non-genetic causes of HIV-1 resistance. Some individuals with HIV1 resistance or slower disease progression may have other genetic or environmental factors not detected by this test. Individuals with one or two copies of the CKR5 gene 32-bp deletion are still at risk for HIV infection and AIDS and should follow the same preventative strategies to reduce or eliminate exposure to the virus that is recommended to the general public.

Clinical Significance

The CKR-5 gene encodes a protein critical for HIV-1 infection. Patients who are heterozygous for a deletion of the CKR-5 gene have prolonged AIDS-free survival. Patients with two defective copies are resistant to HIV-1 infection.

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.