NTD Laboratories, Inc.
403 Oakwood Road
Huntington Station, NY 11746
Phone: 1.888.NTDLABS (683.5227)
ntdlabs@perkinelmer.com
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NTD Laboratories, Inc.




Is Ultra-Screen® A Screening Test?
Yes. In the field of prenatal testing, screening is especially applicable since the diagnostic tests for Down Syndrome and trisomy 18 (Chorionic Villus sampling or Amniocentesis) can cause pregnancy complications or in rare cases a miscarriage. Therefore, it is not practical to provide diagnostic testing to all pregnant women. Instead, the screening test is performed first. The screening test provides the patient with a risk that their pregnancy may be associated with Down Syndrome or trisomy 18. If the risk is high, the patient may then decide that they are interested in a more definitive result by undergoing the diagnostic test. It is important to remember, however, that patients with an elevated risk have not been diagnosed as having a pregnancy associated with Down Syndrome or trisomy 18. The vast majority of such patients give birth to a healthy child. Patients with a low risk for Down Syndrome and trisomy 18 can be reassured about the health of the baby.

What Is Ultra-Screen®?
Ultra-Screen® is a First-trimester prenatal screening protocol designed to provide patient specific risk for Down Syndrome, trisomy 18 and other chromosomal abnormalities. Ultra-Screen® combines ultrasound measurement of the fluid accumulation behind the neck of the fetus (nuchal translucency) with maternal serum markers and is the earliest and most effective Down Syndrome screen available.

How Is Ultra-Screen® Performed?
Ultra-Screen® consists of a combination of ultrasound exam and a blood test performed between 11 weeks 1 day, and 13 weeks 6 days of pregnancy. The ultrasound demonstrates a fetal heartbeat and determines gestational age. Then, the amount of fluid accumulation behind the neck of the baby, called nuchal translucency (NT) is measured. The blood sample is analyzed for two chemicals called free Beta human chorionic gonadotropin, and pregnancy associated plasma protein-A(PAPP-A) which are normally found in the blood of all pregnant women. The results of the ultrasound exam will be combined with the results of the blood test to estimate a specific risk for Down Syndrome and Trisomy 18.

What Does Ultra-Screen® Tell Me And My Doctor?
Ultra-Screen® can provide helpful information about your pregnancy. In most cases, the test can reassure you that your baby is not likely to be at increased risk for certain chromosomal disorders. In some cases, however, the test can alert you and your doctor that your baby may have one of these disorders. Please remember that if your test result does not fall within normal range, it only means that further testing may be indicated.

How Accurate Is Ultra-Screen®?
Ultra-Screen® has been extensively studied and is shown to detect 91%1 of Down Syndrome pregnancies at a 5% false positive rate and 98% of Trisomy 18 pregnancies with a 1% false positive rate.

Who Should Be Tested?
Screening is recommended for patients under 35 years of age. Women age 35 and over and those with a previous child with Down Syndrome are more likely to have a baby affected with Down Syndrome therefore many physicians offer their patients the opportunity to undergo a diagnostic test (CVS or amniocentesis). However, since these diagnostic tests are associated with a small risk of pregnancy complications or miscarriage, many patients prefer to wait and learn their risk of Down Syndrome and trisomy 18 through the Ultra-Screen® test prior to deciding whether to undergo diagnostic testing.

When Should The Test Be Done?
The test should be performed between 11 weeks 1 day and 13 weeks 6 days of pregnancy. In some cases, the patient may elect to have the blood test performed at a different time than the ultrasound exam. The blood test can be performed at anytime between 9 weeks 0 days and 13 weeks 6 days.

* Footnotes

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