Prequel® Prenatal Screen with AMPLIFY™ Technology
Use
Prequel® Prenatal Screen with AMPLIFY™ Technology is a non-invasive prenatal screening test that analyzes cell-free DNA (cfDNA) from a maternal blood sample to estimate the risk for fetal chromosomal abnormalities, including common trisomies (e.g., Down [T21], Edwards [T18], Patau [T13]), sex chromosome aneuploidies, expanded aneuploidies, and select microdeletions such as 22q11.2. AMPLIFY technology enriches the fetal fraction to support reliable results — even at earlier gestational ages (as early as eight weeks) and in patients with high BMI — and delivers results for >99.9% of patients on the first draw. Results describe risk estimates and are intended to support prenatal care and decision-making in conjunction with other clinical and diagnostic information.
Special Instructions
A simple maternal blood draw is performed, and plasma containing cfDNA is isolated and shipped to the laboratory for analysis. Providers should use the Prequel Prenatal requisition form and adhere to specimen collection and shipping instructions to ensure sample integrity. Genetic counseling is recommended pre- and post-test to help patients interpret results and options.
Limitations
Prequel is a screening test and not diagnostic; it provides a risk assessment rather than definitive detection of chromosomal abnormalities — follow-up diagnostic testing (e.g., CVS or amniocentesis) may be indicated for pregnancies with elevated risk scores. Performance may vary with gestational age, fetal fraction, and biological factors, and false positives/negatives can occur. The test’s predictive values depend on background population risk and condition prevalence; results should be interpreted in the context of clinical findings and patient history.
Methodology
NGS (CGP)
Biomarkers
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen Collection Options
This test supports the following collection methods
- Physician Office
- Kit
- Mobile Phlebotomy
Specimen
Plasma
Volume
One 10mL STRECK
Minimum Volume
Not provided
Collection Instructions
Maternal blood draw conducted per standard prenatal screening protocol; plasma separated and processed according to laboratory instructions.
Causes for Rejection
Hemolysis, improper collection/transport, or insufficient sample volume