Cystic Fibrosis D1152H Mutation Analysis [15335X]

Test Code
15335

CPT Codes
81221<br /> ** This test code is for non-New York patient testing. For New York patient testing, use test code 15336X.**

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), or acid citrate dextrose ACD-B (yellow-top) tube

Minimum Volume
3 mL

Other Acceptable Specimens
Whole blood collected in an acid citrate dextrose ACD-A (yellow-top), or sodium or lithium heparin (green-top) tube • Amniotic fluid in a sterile leak-proof container

Instructions
Please indicate ethnicity of the patient.

Whole Blood: Use normal phlebotomy procedure. Do not transfer to other containers. Specimen stability is crucial. Store and transport ambient immediately. Do not freeze specimens.

Extracted DNA: Please call 1-866-GENE-INFO (1-866-436-3463) for additional information.

Transport Temperature
Room temperature

Specimen Stability
Whole Blood:
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Amniotic Fluid (acceptable):
Room temperature: 8 days
Refrigerated: Unacceptable
Frozen: Unacceptable

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: Thurs a.m.; Report available: 9 days

Reference Range
See Laboratory Report

Clinical Significance
This test detects a mutation primarily present in Ashkenazi-Jewish individuals. It can be detected in asymptomatic carriers as well as symptomatic (mild) CF patients.

Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130



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.