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 collected in a sterile, screw-cap container

Minimum Volume

5 mL amniotic fluid • 10 mg chorionic villi

Other Acceptable Specimens

30 mg chorionic villi collected in sterile container with Hanks', Ringer's solution or culture medium with antibiotics

Instructions

Clinical history/reason for referral is required with test order.

Ship at room temperature. Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable

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

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

14225 Newbrook Drive

Chantilly, VA 20153

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.