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KCE reports vol. 6A Prenatale zorg 211
Study Ref Population Intervention Outcomes Results
and PAPP-A, 60%
Maternal age and NT, 79%
Maternal age, NT, free betahCG
and PAPP-A, 90%
Comments Study
type
Wald et
al., 2003
4 [316] 101 cases from
45,712 singleton
pregnancies and 490
matched controls
from 28,434
singleton
pregnancies at 24
maternity centres in
the UK and one in
Austria from 1995
to 2000
Women matched on
centre, maternal age and
crown rump length or
biparietal diameter
Comparison of efficacy of
various methods and
combination of methods
for DownÊs syndrome
screening
Nuchal translucency
obtained at 12 to 13
weeks gestation
Serum and urine samples
taken at 9 to 13 weeks
and also included if taken
at 14 to 22 weeks
Serum tested for AFP,
total hCG, uE3, PAPP-A)
free beta-hCG and
dimeric inhibin A
False positive rate for 75%
and 85% detection rate
Detection rate with false
positive rate fixed at 5%
Estimates of fetal loss
(stillbirth or miscarriage)
due to amniocentesis or
chorionic villus sampling at
85% detection rate, 80%
uptake rate and 0.9% fetal
loss rate attributable to
procedure
Outcomes of DownÊs
syndrome pregnancies
89% (73/82) of women in the
screen positive group chose
invasive testing for prenatal
diagnosis
False positive rate at 75%
detection rate:
Integrated test 0.3%
Serum integrated test
0.8%
Combined test 2.3%
Quadruple test 2.5%
Triple test 4.2%
Double test 6.6%
NT 8.6%
False positive rate at 85%
detection rate (95% CI):
Integrated test 1.2% (1.1 to
1.3)
Serum integrated test 2.7%
(2.4 to 3.0)
Combined test 6.1% (5.7 to
6.5)
Quadruple test 6.2% (5.8 to
6.6)
Triple test 9.3% (8.8 to 9.8)
Double test 13.1% (12.6 to
13.6)
NT 20% (18.6 to 21.4)
Integrated test defined
as NT and PAPP-A at
10 weeks and quadruple
test markers at 14 to
22 weeks
Serum integrated test is
the same as above
minus the NT
Combined test is based
on NT, free beta-hCG,
PAPP-A and maternal
age assessed in the first
trimester
Quadruple test based
on AFP, uE3, free beta-
(or total) hCG, and
inhibin A measurements
with maternal age in the
2nd trimester
Triple test based on
AFP, uE3, free beta-(or
EL
CCS 3