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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 screening available.

How is Ultra-Screen® performed?

Ultra-Screen® consists of a combination of an ultrasound exam and a blood test performed between 11 weeks 1 day and 13 weeks 6 days gestational age. The ultrasound demonstrates a fetal heartbeat and determines gestational age, measurement of the length of and by the early fetus called Crown Rump Length (LRL) 45-84. 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.

Why is Ultra-Screen® so significant?

  • Ultra-Screen® offers 91% detection in the first trimester.
  • Provides you with answers much earlier in pregnancy than all other Down syndrome screening tests.
  • Ultra-Screen® offers earlier reassurance for most patients.
  • Patients who are shown to be at increased risk will have added time to consider if they want to have a diagnostic procedure done, such as amniocentesis or CVS.

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 is Ultra-Screen® different from amniocentesis or CVS?

Ultra-Screen® is a non-invasive screening test to determine how likely it is that your baby has Down syndrome or trisomy 18. Amniocentesis and CVS are invasive procedures that determine definitely the presence or absence of Down syndrome, trisomy 18 and other less common birth defects. However, since these procedures are invasive and there is a slight chance they could harm your baby, they are not routinely offered.

How accurate is Ultra-Screen®?

Ultra-Screen® has been extensively studied and is shown to detect about 90% of Down syndrome pregnancies at a 5% false positive rate and 98% of trisomy 18 pregnancies with a 1% false positive rate. In addition, patients carrying babies with other chromosomal disorders or birth defects may have a positive Ultra-Screen®. However, a normal Ultra-Screen® does not eliminate the possibility that the baby may have Down syndrome, trisomy 18 or other chromosomal abnormalities, nor does the test eliminate the possibilities of birth defects, mental retardation and other disorders not detectable by Ultra-Screen®. In the majority of cases, no increased risk is found and patients can be reassured that it is unlikely that their baby has Down syndrome or trisomy 18.

What is Down syndrome?

Down syndrome is a chromosomal disorder that causes physical and mental retardation and birth defects, which may involve the heart and/or digestive tract. The degree of physical and mental retardation for individuals affected by Down syndrome varies greatly. For some, it is minimal; for others, it is substantial. Down syndrome affects approximately one in every 800 babies. 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. However, most cases of Down syndrome occur in women under age 35 because they have more babies overall.

What is trisomy 18?

Trisomy 18 is a more severe chromosomal disorder that causes profound mental retardation and multiple birth defects. Few trisomy 18 babies live longer than one year, though some do survive into childhood. Like Down syndrome, the chance to have a pregnancy with trisomy 18 increases with increased maternal age.

What happens if Ultra-Screen® shows that I am at increased risk?

If the Ultra-Screen® test indicates an increased risk for chromosomal abnormalities, you will receive genetic counseling to explain the test results and your options for further testing. These options may include CVS (a test in which a small amount of placental tissue is collected) or amniocentesis (a test in which a small amount of fluid from around the baby is collected) for chromosomal analysis.

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 any time between 9 weeks 0 days and 13 weeks 6 days.

Early Screening Patient Pamphlet (For California Residents Only)

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