Maternal Cell Contamination Study, STR Analysis

Test Code
10262

CPT Codes
81265<br /> <strong>This test is not available for New York patient testing. For New York patient testing use test code 10477.</strong>

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
5 mL whole blood collected in an EDTA (lavender-top) tube

Minimum Volume
3 mL

Other Acceptable Specimens
Whole blood collected in: ACD solution (yellow-top), or sodium heparin (green-top) tube

Instructions
This test is run in conjunction with either a fetal specimen (amniotic fluid, dissected chorionic villus (CVS) biopsy or products of conception) or a cord blood sample.

The assay cannot be run until fetal cultures are ready. The TAT is therefore dependent on the TAT of the fetal DNA test on the same patient.

Transport Temperature
Room temperature

Specimen Stability
Room temperature: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Methodology
Multiplex Polymerase Chain Reaction • Fragment Analysis by Capillary Electrophoresis

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 the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Run in conjunction with fetal clinical assay; Report available: 1 week after set up

Reference Range
See Laboratory Report

Clinical Significance
Maternal Cell Contamination Study, STR Analysis, provides assurance that test results from fetal specimens are not influenced by contaminating maternal material. This test also allows for establishing the proper maternal-fetal relationship between specimens by using sophisticated analysis of 15 highly polymorphic STR loci.

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.