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QNatal® TGSCA
Test Code93321
CPT Codes
81420<br><strong>This test is not available for California patient testing</strong><br>Restricted Client Code
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.
Transport Temperature
Room temperature
Specimen Stability
Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Shipping refrigerated unacceptable • Shipping frozen unacceptable
Methodology
Next Generation Sequencing
FDA Status
QNatal Advanced is a laboratory developed test that has been developed and validated, pursuant to the Clinical Laboratory Improvements Amendments of 1988 (CLIA), and as such it has not been reviewed by FDA.
Setup Schedule
Set up: Daily; Report available: 6-8 days
Clinical Significance
QNatal® Advanced 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, Trisomy 13, and certain sex chromosome 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).
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).
