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Qnatal(TM) Advanced
MessageDo not draw before 10 weeks gestation.
Use Streck tubes only. Volume 20 mL (16 mL minimum)
whole blood collected in two Streck cell-free (black/tan tiger top)
glass tubes (10 mL in each tube).
Test Code
QNATL
Alias/See Also
NIPT
LAB12395
CPT Codes
81420
Preferred Specimen
10 mL whole blood collected in (x2) each of two separate Streck
cell-free (black/tan tiger-top)
Minimum Volume
8 mL (x2)
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 Refrigerate: Unacceptable Frozen:
Unacceptable
Methodology
Next Generation Sequencing
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.
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
Daily
Report Available
6-8 days
Reference Range
See Laboratory Report
Clinical Significance
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).
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).
Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano 33608 Ortega Highway San Juan Capistrano, CA 92675
Last Updated: February 17, 2023