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Test Directory FISH, Prenatal Screen

FISH, Prenatal Screen

Order Code: PNTLF

Test Summary

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).

Aliases

Specimen Collection

Special Instructions

N/A

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.

Patient Preparation

N/A

Storage

N/A

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.

Limitations

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

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

PNTLF

EPIC (Premier) Code

LAB3181

Includes

Includes Chromosomes: 13,18,21,X,Y

**Test may be replaced by Cytogenetics Communication**

CPT Code

88271 (x5)
88274 (x2)

Billing Code

671048
671049

CPT Statement

Methodology

Fluorescence In Situ Hybridization (FISH)

FDA Status

The analytical performance characteristics of this assay have been determined by Quest Diagnostics Nichols Institute. 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.

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.

Testing Laboratory

Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675

Department

Reference Testing

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Mornings; 7 days a week.