Whole blood samples will be collected from high-risk pregnant women to validate the clinical performance of the SEQureDx Trisomy 21 Test.
Study Type
OBSERVATIONAL
Enrollment
3,062
Clinical Assay Performance
Each subject will provide a single blood sample prior to undergoing an amniocentesis/CVS that will be processed to plasma and stored frozen until the end of the study. Frozen plasma samples will then be analyzed using the SEQureDx Trisomy Test and the sensitivity and specificity of the assay will be determined by comparing the plasma test results to the fetal karyotyping results obtained via aminiocentesis or CVS. A subject's participation ends after the results of the fetal karyotype are obtained and recorded.
Time frame: Performance of the assay will be based upon a single blood sample collected during the only study visit from a high risk pregnancy prior to the subject undergoing an invasive procedure (amniocentesis or CVS) to confirm fetal karyotype.
Subject selection bias assessment
All subjects that enter the study are at high risk for fetal aneuploidy. However, sensitivity and specificity of the assay will be based upon those subjects that have a confirmed fetal karyotype obtained by amniocentesis/CVS. Subject selection bias assessment will be done by comparing SEQureDx Trisomy T21 Test results between women who agree to undergo an invasive procedure to obtain fetal karyotype and women who elect not to undergo an invasive procedure.
Time frame: A single blood sample will be collected at a single clinic visit from high risk pregnancies that refuse to undergo an invasive procedure.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of South Alabama
Mobile, Alabama, United States
Visions Clinical Research Tuscon
Tucson, Arizona, United States
Obstetrix Medical Group of California
Campbell, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
San Gabriel Valley Perinatal Medical Center
Monterey Park, California, United States
Scripps Clinic Carmel Valley
San Diego, California, United States
South Florida Perinatal
Miami, Florida, United States
Southeast Perinatal Associates - Miramar
Miramar, Florida, United States
Southeast Perinatal Associates - Weston
Sunrise, Florida, United States
...and 19 more locations