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Cystic Fibrosis DNA Analysis, Fetus

Test code

10226

CPT code(s)*

81220, 88235
Notices
**CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide Service area information to confirm Test Code for the lab that services your account or to find available tests you can order.
In-home collection is not available in your area through Quest Mobile.

Clinical significance

Cystic Fibrosis DNA Analysis, Fetus - Cystic fibrosis (CF) is the most common recessive lethal genetic disorder affecting primarily Caucasians of Northern European descent, with an incidence of approximately 1 in 3300 births and a carrier rate of 1 in 29. This test is appropriate to determine if the fetus has inherited known mutations, limited to the general cystic fibrosis mutation panel, from both parents.
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Test resources

Test guide

Cystic Fibrosis Test Selection Guide

Details

Test details

Methodology

Multiplex PCR • Massively Parallel Sequencing

Assay category

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.

Alternative name(s)

CF DNA Fetus

Specimen requirements
Patient preparationNone Specified
Preferred specimen(s)10 mL amniotic fluid collected in a sterile plastic leak-proof container
Alternative specimen(s)Amniocyte or chorionic villus (CVS) culture cells collected in each of two sterile T25 flasks • 10 mg dissected chorionic villus (CVS) biopsy collected in a sterile tube filled with sterile culture media
Minimum volume10 mL amniotic fluid • 10 mg dissected chorionic villus biopsy
Collection instructions

Do not hold specimen; forward to laboratory when specimen arrives.

For fetal testing:
1) Please call 1-866-GENE-INFO (1-866-436-3463) prior to submission
2) Documentation of parental carrier status must be provided
3) It is required that maternal cell contamination study, STR analysis be ordered in conjunction with fetal testing. A separate tube of maternal blood (EDTA) is required for this test.

Amniotic fluid: Normal collection procedure. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.

Amniocyte or chorionic villus (CVS) culture: Two sterile T25 flasks, 75% confluent, filled with culture medium. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when cells arrive.

Dissected chorionic villus (CVS) biopsy: 10-20 mg dissected chorionic villi collected in a sterile tube, filled with sterile culture media. Specimen stability is crucial. Store and ship at room temperature immediately. Do not refrigerate or freeze; forward to laboratory when sample arrives.

Note: Do not reject. Forward to performing laboratory for evaluation of sample.

Transport containerSterile plastic leak-proof container
Transport temperatureRoom temperature
Specimen stabilityRoom temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Service Area Information
Service Area Information

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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