QNatal® Chr 13,18,21, SCA, 22q Microdel

Test Code

14302

CPT Codes
81420

Preferred Specimen

10 mL whole blood collected in Streck cell-free (black/tan tiger-top) glass tube

Minimum Volume

8 mL

Instructions

Do not draw before 10 weeks gestation. Sample collection using a straight needle (not a butterfly needle) is preferred. Use Streck tube only.

Transport Temperature

Room temperature

Specimen Stability

Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable

Methodology
Next Generation Sequencing (NGS)

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: 6-8 days

Reference Range

See Laboratory Report

Clinical Significance

QNatal Chr 13,18,21, SCA, 22q Microdel is a cell-free DNA test that screens for increased risk of certain fetal chromosomal abnormalities that may cause birth defects, including Trisomy 21 (Down Syndrome), Trisomy 18 (Edwards Syndrome), Trisomy 13 (Patau Syndrome) and certain sex chromosome abnormalities (i.e., 45,X, 47,XXY, 47,XXX, and 47,XYY). In addition, QNatal Chr 13,18,21, SCA, 22q Microdel can screen for 22q microdeletions that may cause birth defects, and/or for fetal sex.

This test does not assess the risk of fetal anomalies such as neural tube defects or ventral wall defects. QNatal Chr 13,18,21, SCA, 22q Microdel is not recommended before 10 weeks of gestation due to a significantly increased risk of a failed result.

QNatal Chr 13,18,21, SCA, 22q Microdel is a screening test, not a diagnostic test, and therefore all positive/increased risk results should be followed by genetic counseling and further diagnostic testing and procedures, when clinically indicated. Pregnancy management decisions should not be based on the results of this screening test alone. As with any test, there may be false positives or false negatives.

The positive predictive value varies by patient risk factors as well as by genetic marker, and may be lower for rare conditions. Performance data for QNatal Chr 13,18,21, SCA, 22q Microdel may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463).

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.