Banner Image

Test Directory

QNatal® Advanced

Test Summary

QNatal® Advanced is a cell-free DNA test that screens for increased risk of certain fetal chromosomal abnormalities (i.e., 45,X, 47,XXY, 47,XXX, and 47,XYY). In addition, if selected as an option, QNatal Advanced can screen for certain microdeletions (ie., 22q, 5p, 1p36, 15q, 11q, 8q, and 4p) 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 Advanced is not recommended before 10 weeks gestation due to a significantly increased risk of a failed result.

QNatal Advanced 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 a cfDNA 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 the QNatal Advanced may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463).

Aliases

  • N/A

Specimen Collection

Special Instructions

N/A

Preferred Specimen

10 mL whole blood collected in a 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 tubes only.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerate: Unacceptable
  • Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Order Code

QNATAL

EPIC (Premier) Code

LAB5988

Includes

N/A

CPT Code

  • 81420

Billing Code

  • 670859

CPT Statement

Methodology

Next Generation Sequencing

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. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Physician Attestation of Informed Consent

N/A

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

Daily; Report available: 6 - 8 days

Specimen Collection

Special Instructions

N/A

Preferred Specimen

10 mL whole blood collected in a 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 tubes only.

Patient Preparation

N/A

Storage

N/A

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 7 days
  • Refrigerate: Unacceptable
  • Frozen: Unacceptable

Limitations

N/A

Other Acceptable Specimens

N/A

Unacceptable Specimens

N/A

Billing

CPT Code

  • 81420

Billing Code

  • 670859

CPT Statement

Result Information

Methodology

Next Generation Sequencing

Testing Laboratory

N/A

Reference Range

See Laboratory Report

Setup Schedule / Expected Turnaround Time

Daily; Report available: 6 - 8 days