FISH, Products of Conception (POC) Panel

Test Code

14820

CPT Codes
88274 (x3), 88271 (x7)

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.

Includes

Chromosomes 13, 16, 18, 21, 22, X, Y

Preferred Specimen

5x5 mm fetal tissue collected in a sterile container in Hanks', Ringer's solution or culture medium with antibiotics

Minimum Volume

2x3 mm fetal tissue

Other Acceptable Specimens

5x5 mm fetal tissue in saline solution submitted in a sterile leak-proof container • POC formalin-fixed, paraffin-embedded tissue block • Cultured cells collected in two T-25 flasks • 5 unstained, positively (+) charged slides prepared from formalin-fixed, paraffin-embedded tissue block

Instructions

Fetal tissue sample minimum of 2x3 mm collected in a sterile container with Hanks', Ringer's solution, culture medium with antibiotics, or saline solution.
Transport media should be refrigerated before use, but can be shipped 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
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.

Setup Schedule

Set up: Daily; Report available: 8 days

Limitations

The FISH test is limited in that it only counts the number of each of the included chromosomes (13, 16, 18, 21, 22, X, and Y). 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

Approximately 15% of all clinically recognized pregnancies are spontaneously aborted (SAB). A significant number of these samples in culture do not yield metaphase cells to perform cytogenetic studies. Using FISH probes will allow for detecting common cytogenetic abnormalities.

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.