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QNatal® Chr 13,18, 21
Test Code14315
CPT Codes
<br><strong>Restricted use: This code is available to 58130 only</strong>
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. Volume 10 mL (8 mL minimum) whole blood collected in a Streck cell-free (black/tan tiger-top) tube.
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?)
Whole blood collected in other than Streck tube
Methodology
Next Generation Sequencing
Setup Schedule
Set up: Daily; Report available: 5-7 days
Clinical Significance
QNatal Chr 13,18,21 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/or 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 is not recommended before 10 weeks of gestation due to a significantly increased risk of a failed result.
QNatal Chr 13,18,21 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. All results should be interpreted in the context of pertinent clinical findings, relevant obstetric history and laboratory data based on a clear understanding of the value and limitations of the test data.
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, may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463).
This test does not assess the risk of fetal anomalies such as neural tube defects or ventral wall defects. QNatal Chr 13,18,21 is not recommended before 10 weeks of gestation due to a significantly increased risk of a failed result.
QNatal Chr 13,18,21 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. All results should be interpreted in the context of pertinent clinical findings, relevant obstetric history and laboratory data based on a clear understanding of the value and limitations of the test data.
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, may be obtained by contacting Quest Diagnostics at 1.866.GENE.INFO (1.866.436.3463).
