FISH, Prenatal Screen

Test Code

14604

CPT Codes
88271 (x5), 88274 (x2)

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

20 mL amniotic fluid in a sterile, screw-cap container OR 30 mg chorionic villus sample in culture media

Minimum Volume

5 mL amniotic fluid • 10 mg chorionic villus sampling

Instructions

Amniotic fluid: 20 mL in a sterile container
Chorionic villus sample: 30 mg chorionic villi in sterile container with Hanks', Ringer's solution or culture medium with antibiotics. CVS media available upon request.

Transport Container

Sterile container
Culture media

Transport Temperature

Room temperature

Specimen Stability

Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not Reject.

Methodology
Fluorescence in situ Hybridization (FISH)

FDA Status
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

p.m. Daily

Report Available

24-48 hours from receipt of sample in laboratory

Limitations

This assay will not detect chromosome mosaicism, duplications, deletions, or structural rearrangements and does not identify all birth and/or developmental abnormalities.

Reference Range

See Laboratory Report

Clinical Significance

This fluorescence in situ hybridization (FISH) prenatal screening test is used for numerical abnormalities of chromosomes X, Y, 13, 18, and 21 in amniotic fluid and chorionic villus samples. Since this is a screening test, the results MUST be evaluated in conjunction with a standard chromosome study or a chromosomal microarray (CMA) study. Medical decisions should not be based solely on FISH screen results. The American College of Medical Genetics recommends that irreversible therapeutic action should not be taken based on the results of FISH analysis alone (Am. J. Hum. Genet. 53: 526-527, 1993).

Performing Laboratory

Quest Diagnostics Nichols Institute-Chantilly VA

14225 Newbrook Drive

Chantilly, VA 20151-2228

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.