UltraScreen^®
First Trimester Prenatal Screening 
freeBeta, PAPP-A with Nuchal Translucency (NT) Ultrasound

What is UltraScreen^®?
First trimester screening of a maternal dried blood sample analyzes for two proteins, freeBeta-hCG and PAPP-A, to provide a patient specific risk for Down syndrome (DS) and Trisomy-18 (T-18). UltraScreen is the protein test combined with an ultrasound measurement of nuchal translucency (NT), which is the fluid accumulation under the skin in the back of fetal neck. 

Studies have shown NT can be measured consistently only by sonographers who have special training and maintain certification from the Fetal Medicine Foundation (FMF). UltraScreen is an acceptable medical procedure when performed by sonographers who are certified by the FMF, receive NT median monitoring from GeneCare and yearly recertification from the FMF. The NT measurement is recorded on the ScreenSpot Plus requisition to be combined with the biochemistry. Reports are then called, faxed and/or mailed to your office. Genetic counseling, early amniocentesis and/or CVS should be made available to patients if diagnostic follow-up is needed.

First trimester screening is preferred by 100% of surveyed patients (Monni, et al., 1999). Early testing provides patient privacy and reduced anxiety. UltraScreen and biochemistry alone provide significantly higher detection and lower false positives than second trimester triple or quad screening.

 Why Provide UltraScreen^®?

• UltraScreen detects 91% of DS and 97% of T-18 and exceeds triple and quad DS detection by 50% . Biochemistry alone detects 68% for DS and >90% for T-18 with a low 4.5% false positive rate.

• UltraScreen significantly reduces DS false positives to 2.5%, less than 40% of triple or quad screens for safer screening
• The YIELD for both DS and T-18 is 1 identified case out of 17 CVS’ or early amniocenteses performed, more than 3 TIMES that of triple or quad screening!
• NT helps identify pregnancies at increased risk for chromosomal abnormalities, many other anomalies, and ~40% of heart defects .
• UltraScreen reduces unnecessary anxiety, saves time and cost, and decreases unnecessary diagnostic amniocenteses and CVS’s
• UltraScreen meets ACOG and FMF guidelines for clinical screening and has been fully documented in the USA (over 80,000 tests) and internationally (over 250,000 NT’s in over 60 countries) Two large USA prospective studies (Krantz, et al, 2000 and the NIH BUN Study, 2002) confirm the clinical efficacy of UltraScreen. UltraScreen is 35% more cost effective than triple screen (SMFM, 2002).
• GeneCare can assist with NT certification, genetic counseling, ultrasound, amniocentesis/CVS as needed and referrals to certified NT centers.
• Studies have conclusively shown freeBeta hCG is associated with DS (2.7MOM), Intact hCG (1.2MOM) cannot be used for accurate first trimester screening.Integrated tests and Inhibin A are still research until prospective studies are performed and published.

Follow-up for First Trimester Screens

• Patients who receive Within Normative Range results should be offered 1) GeneCare’s second trimester AFP test to screen for 98% of open spine and skull birth defects or 2) targeted fetal ultrasound
• Most women who have a Within Normative Range first trimester screen result elect to not have a follow-up second trimester chromosome screen. Those who do should have AFP/freeBeta to reduce false positives to 1-2% vs. over 10% for triple screen (NICHD-BUN,2002).
• First trimester increased risk tests should NOT be repeated. Genetic counseling, CVS and/or early amniocentesis should be offered
• All patients with an NT > 3.5mm without a fetal chromosomal abnormality should be offered a fetal targeted U/S and echocardiogram around 20 weeks to detect many other NT associated anomalies and 40% of heart defects

UltraScreen Summary

• UltraScreen with NT detects 91% of DS and 97% of T-18 with <2.5% false positives
• freeBeta/PAPP-A alone detects 68% of DS and 90% of T-18 with <2.5% false positives
• Early detection of ~40% of heart defects, many other anomalies and perinatal risks
• Earliest, most accurate screening with highest detection, lower false positives, highest yield
• Preferred by 100% of surveyed patients
• NT certification required to insure accuracy, QC
• NT should ONLY be offered with biochemistry to reduce false positives from 8.3% to <2.5%, and to increase detection by 10%
• CVS, early amniocentesis, and genetic counseling should be available for increased risk patients
• UltraScreen DS TWIN detection: 80% with 7.4% vs. 12.6% false positives with NT alone
• Covered by the majority of insurance providers. Contact us for current list
• Free Supplies & Transport
• Call GeneCare or visit "genecare.com" for information and Official NT Certification Courses

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  Last modified: May 25, 2004 04:26 PM
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