CFvantage® Cystic Fibrosis Expanded Screen
Test code
CPT code(s)*
Test resources
Details
Includes
If amniotic fluid or chorionic villi sampling (CVS) is received, then an additional charge will be added for cell culture work (CPT code(s): 88235) if not already ordered
Methodology
Multiplex PCR • Next Generation 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 Expanded Mutation Carrier Screen,CFTR Expanded Mutation Screen,Cystic Fibrosis Expanded Panel,CF155 Mutations,CF Carrier Screen,CF Mutation Screen,Cystic Fibrosis Mutation Screen,Cystic Fibrosis Carrier Screen,CFTR Screen
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 5 mL whole blood collected in an EDTA (lavender-top) tube |
| Alternative specimen(s) | Whole blood collected in: ACD (yellow-top) tube or sodium heparin (green-top) tube Fetal specimens: 10 mL amniotic fluid collected in a sterile plastic leak-proof container • Amniocyte or chorionic villus (CVS) culture cells collected in each of two sterile T-25 flasks • 10 mg dissected chorionic villus (CVS) biopsy collected in a sterile tube filled with sterile culture media |
| Minimum volume | 3 mL whole blood • 10 mL amniotic fluid • 10 mg dissected chorionic villus biopsy |
| Collection instructions | Do not hold specimen; forward to laboratory when specimen arrives. Whole blood: Specimen stability is crucial. Store and ship at room temperature immediately. Do not freeze. 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 sample arrives. 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 container | EDTA (lavender-top) tube |
| Transport temperature | Room temperature |
| Specimen stability | Whole blood Room temperature: 8 days Refrigerated: 8 days Frozen: Unacceptable Fetal specimens Room temperature: 48 hours Refrigerated: Unacceptable Frozen: Unacceptable |
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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