| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
QNatal® Chr 13,18,21, SCA, 22q Microdel
Test Code14302
CPT Codes
81420, 81422
Preferred Specimen
10 mL whole blood collected in a Streck cell-free (black/tan tiger top) glass tubes
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
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: 5-7 days
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).
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).
