For individuals with suspected CF. This test is NOT indicated for routine carrier screening. If individual is not symptomatic, order Cystic Fibrosis (CFTR) Expanded Variant Panel (2013661).
Matrix-Assisted Laser Desorption Ionization-Time of Flight (MALDI-TOF)
New York DOH Approval Status
Fetal Specimen: Two T-25 flasks of cultured amniocytes at 80 percent confluency. *If the client is unable to culture amniocytes, this can be arranged by contacting ARUP Client Services at (800) 522-2787.
Maternal Whole Blood Specimen: Lavender (EDTA), pink (K2EDTA).
Cultured Amniocytes: Fill flasks with culture media. Backup cultures must be retained at the client's institution until testing is complete.
Maternal Whole Blood Specimen: Transport 3 mL whole blood. (Min. 1 mL)
Cultured Amniocytes: CRITICAL ROOM TEMPERATURE. Must be received within 48 hours of shipment due to lability of cells.
Maternal Whole Blood Specimen: Refrigerated.
Maternal Whole Blood Specimen: Plasma or serum. Specimens collected in sodium heparin, yellow (ACD solution), or lithium heparin tubes. Frozen specimens in glass collection tubes.
Maternal whole blood sample is recommended for proper test interpretation; order Maternal Cell Contamination, Maternal Specimen. Patient History Form is available on the ARUP Web site or by contacting ARUP Client Services.
Fetal Specimen: Ambient: 48 hours; Refrigerated: Unacceptable; Frozen: Unacceptable
Maternal Whole Blood Specimen: Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month
Refer to report.
For quality assurance purposes, ARUP Laboratories will confirm the above result at no charge following delivery. Order Confirmation of Fetal Testing and include a copy of the original fetal report (or the mother's name and date of birth) with the test submission. Please contact an ARUP genetic counselor at (800) 242-2787 extension 2141 prior to specimen submission.
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.
Laboratory Developed Test (LDT)
The Cystic Fibrosis (CFTR) Expanded Variant Panel includes 23 pathogenic CFTR variants recommended by the American College of Medical Genetics for population carrier screening.
81220; 81265 Fetal Cell Contamination (FCC)
|Component Test Code*||Component Chart Name||LOINC|
|0050548||Maternal Contamination Study Fetal Spec||59266-7|
|0050612||Maternal Contam Study, Maternal Spec||66746-9|
|2013675||Cystic Fibrosis, Allele 1||42938-1|
|2013676||Cystic Fibrosis, Allele 2||42939-9|
|2013680||CF, Expanded Var Pan Fetal, Interp||38404-0|
|2013692||Cystic Fibrosis 5T Variant||21654-9|
- Fetal CF screening test