Elsevier

Seminars in Perinatology

Volume 29, Issue 4, August 2005, Pages 225-235
Seminars in Perinatology

SURUSS in Perspective

https://doi.org/10.1053/j.semperi.2005.05.006Get rights and content

Background

Until the publication of the Serum Urine and Ultrasound Screening Study (SURUSS) report, it was difficult to compare the different antenatal screening tests for Down’s Syndrome because of variations in study designs. We here present the main results from SURUSS, updated to take account of recent information on nuchal translucency in Down’s Syndrome pregnancies, and discuss their implications.

Methods

SURUSS was a prospective study of 47,053 singleton pregnancies (including 101 pregnancies with Down’s Syndrome) conducted in 25 maternity units. Nuchal translucency measurements were taken. Serum and urine samples collected between 9 and 13 weeks, and again between 14 and 20 weeks of pregnancy were stored. Samples from each affected pregnancy and five matched controls were tested for currently used or suggested biochemical Down’s Syndrome screening markers. Pregnancies were followed up to determine the presence or absence of Down’s Syndrome. For an 85% Down’s Syndrome detection rate, the false-positive rate for the Integrated test (nuchal translucency and pregnancy associated plasma protein-A [PAPP-A] at 11 completed weeks of pregnancy, and α-fetoprotein, unconjugated oestriol [uE3], free β or total human chorionic gondaotrophin (hCG) and inhibin-A in the early second trimester) was 0.9%, the Serum integrated test (without nuchal translucency) 2.7%, the Combined test (nuchal translucency with free β-hCG and PAPP-A at 11 weeks) 4.3%, the Quadruple test (α-fetoprotein, uE3, free β or total hCG and inhibin-A) 6.2%, and nuchal translucency at 11 weeks, 15.2%. All tests included maternal age. Using the Integrated test at an 85% detection rate, there would be six diagnostic procedure-related unaffected fetal losses following amniocentesis per 100,000 women screened compared with 35 using the Combined test or 45 with the Quadruple test.

Conclusions

The Integrated test offers the most effective and safe method of screening for women who attend in the first trimester. The next best test is the Serum integrated test. The Quadruple test is the best test for women who first attend in the second trimester. There is no justification for retaining the Double (α-fetoprotein and hCG) or Triple (α-fetoprotein, uE3, and hCG) tests, or nuchal translucency alone (with or without maternal age) in antenatal screening for Down’s Syndrome.

Section snippets

Methods

SURUSS was based on 47,507 women recruited between September 1996 and April 2000 who attended 25 maternity centres (24 in the United Kingdom and one in Austria). Follow up was carried out to 31 May 2001. Outcomes were known for 96% of all pregnancies and ascertainment of Down’s Syndrome was probably complete through crosschecking with the National Down’s Syndrome Cytogenetic Register. There were 47,053 singleton pregnancies, including 101 with Down’s Syndrome. The number of Down’s Syndrome

Results

The most effective screening test was the Integrated test, with an estimated 85% detection rate for a 0.9% falsepositive rate—about one-fifth the number of false-positives that would arise using the first trimester Combined test or second trimester Quadruple test at the same detection rates (see Fig. 1). At an 85% detection rate, the false-positive rate for the Serum Integrated test was 3.9%, and 4.3% for the Combined test with the first trimester markers measured at 11 weeks. It was 6.2% for

Discussion

SURUSS provides, for the first time, a data set based on a single cohort of screened women, from which any combination of the specified screening markers within the first or second trimesters, or across both trimesters can be examined.

The main results of the SURUSS study were based on over 47,000 singleton pregnancies of which 101 had Down’s Syndrome, close to what we had aimed for in the protocol (50,000 pregnancies and 100 with Down’s Syndrome). SURUSS had the statistical power to yield

Conclusion

Our results show that, on the basis of efficacy, safety and cost, the Integrated test is the test of choice, confirming previous estimates based on combining the results from different studies.23 Adding other markers provided little benefit. If a nuchal translucency measurement was unavailable, the Serum Integrated test would be the next best screening method, with a better screening performance than any first or second trimester serum screening test. A multicentre demonstration project in

Acknowledgements

The SURUSS project was supported under the UK Health Technology Assessment research and development programme.

Declaration of interests

St Bartholomew’s and the Royal London School of Medicine and Dentistry together with the Foundation for Blood Research and Women and Infants Hospital (Providence, Rhode Island) hold a patent for unconjugated oestriol measurement as a marker for Down’s Syndrome screening. Professor Wald is a director of Logical Medical Systems, which produces alpha, a commercial interpretive software package for Down’s Syndrome screening using ultrasound and serum markers. He is also a director of Intema, which

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