A
5200 Harry Hines Blvd.
,
Dallas
,
TX
75235
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General Information
Performed: M-F First Shift
Turn Around Time: 4-5 days
CPT Codes: 81420,81507
Performed By: Chemistry
Notes:
Rolling-circle-replication technology is utilized on Vanadis NIPT, rather than PCR, to reduce variability. Vanadis NIPT directly captures target chromosomal fragments and labels them for high-yield counting, enabling high-performance screening for fetal aneuploidies.
This test was developed and its performance characteristics determined by Clinical Chemistry/Parkland Health. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research
Clinical Utility:
Screening is limited to aneuploidy of chromosomes 21, 18, 13 and the presence of Y chromosome if requested. Other genomic abnormalities will not be identified by this test. This assay has not been validated on multiple gestations nor on samples gathered prior to 10 gestational weeks at this time. No irreversible clinical decisions should be made based on these screening results alone. Clinical correlation with history and other testing results is suggested.
This screening assay and a negative result does not rule out a fetal chromosome abnormality or guarantee a healthy baby.
Components
Name |
Method |
Sex |
Age Range |
Ref. Range Low |
Ref. Range High |
Units |
TRISOMY 13 |
Imaging, no sequencing, no microarray |
|
|
Screen Negative |
|
|
TRISOMY 18 |
Imaging, no sequencing, no microarray |
|
|
Screen Negative |
|
|
TRISOMY 21 |
Imaging, no sequencing, no microarray |
|
|
Screen Negative |
|
|
NON INVASIVE PRENATAL INTERPRETATIVE DATA |
Imaging, no sequencing, no microarray |
|
|
Screen Negative |
|
|
Specimen Requirements
Type |
Container |
Volume |
Units |
Collection / Delivery |
Storage / Transport |
Off Campus |
WHOLE BLOOD |
Streck Cell-Free DNA BCT* two tubes required for each patient* |
10 mL each tube |
|
Collect two Streck Cell-Free DNA BCT tubes of whole blood. Deliver to Logistics laboratory. Specimens are stable for 5 days after collection. |
Room Temperature. Do Not Spin. |
Collect two Streck Cell-Free DNA BCT tubes of whole blood. Do not spin. Deliver to Logistics laboratory at room temperature. |