What is the Ultra-Screen® protocol?
The Ultra-Screen protocol is a first-trimester prenatal screening procedure that provides patient specific risk assessment for Down syndrome and trisomy 18/13. The Ultra-Screen protocol combines ultrasound measurement of the fluid accumulation behind the neck of the fetus (nuchal translucency) with maternal serum markers to deliver the earliest and most reliable Down syndrome screen available, with a detection rate of 91% and a false positive rate of just 5%.
What is the detection rate?
The Ultra-Screen protocol has been extensively studied and validated by numerous investigational studies and two NIH-sponsored trials. It is proven to detect 91% of Down syndrome pregnancies with a 5% false positive rate and 95% of trisomy 13 pregnancies with a 0.3% false positive rate. References
Who should be screened?
Women age 35 and older and those with a family history of Down syndrome are more likely to have a pregnancy affected by Down syndrome. However, most cases of Down syndrome occur in women younger than 35. Leading medical professional organizations recommend first trimester Down syndrome screening for all pregnant women. References
At what gestational age should the Ultra-Screen protocol be performed?
The Ultra-Screen protocol consists of two parts: a blood test between 9 weeks to 13 weeks, 1 day; and an ultrasound examination performed between 11 weeks, 1 day to 13 weeks, 6 days gestation. The blood test can be performed as early as nine weeks after conception. The ultrasound window of 11 weeks, 1 day to 13 weeks, 6 days is consistent with a crown rump length of 45-84 mm.
How is the Ultra-Screen protocol performed?
Performed from 9 to 13 weeks, and 6 days from conception, the Ultra-Screen free Beta/PAPP-A/NT screen provides a care path for Down syndrome risk assessment that is simple to follow.
In the earlier stages of the protocol (9 to 11 weeks, 1 day), you will provide a dried blood sample obtained from a simple, safe finger stick procedure. Venous blood from a venipuncture may also be used, but dried blood sampling provides a more effective way to collect, store and process maternal serum specimens. Maternal blood specimens are spotted onto an absorbent test card either at your physician’s practice or at your home.
Immediately after the blood spot is done, the cards are sent directly to NTD Labs where they are processed, tested and archived according to protocol.
That data and the results of the blood screen are maintained at NTD Labs and made available to the physician when you undergo your NT (and optional fetal nasal bone assessment) ultrasound exam between 11 weeks, 1 day and 13 weeks, 6 days.
What are the advantages of the Ultra-Screen protocol?
- For those shown to be at low risk, Ultra-Screen® reduces the use of unnecessary diagnostic procedures that increase health risks to patient and fetus
- For those shown to be at high risk, Ultra-Screen® gives the patient and physician more time to consider follow-up diagnostic options such as CVS (chorionic villus sampling) or amniocentesis
- Safe, simple and non-invasive, so patients are more likely to undergo the screening
- Provides separate twin reports
- Provides separate trisomy 18/13 results