
VALUE OF THE COMBINED TEST
IN PRENATAL DIAGNOSTICS Lončar D *Corresponding Author: Dragan Lončar, Gynecology and Obstetrics Clinic, Clinical Center
Kragujevac , Vojislava Kalanovića 1A/3, 34000 Kragujevac, Serbia; Tel.: +381-64-616-8999;
E-mail: drloncar@sezampro.rs page: 53
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INTRODUCTION
Congenital anomalies cause 20.0-25.0% of
perinatal deaths, while 3.0% of children are born
with malformations of varying size [1]. Analytical
immunochemiluminescence assays and an
automated analyzer IMMULITE 2000 [Diagnostics
Product Corporation (DPC), Los Angeles, CA,
USA] were used. Usable values of the combined
test were estimated on the basis of its sensitivity,
specificity and possibility of the disease in case the
result was positive. By combining the values of
pregnancy-associated plasma protein A (PAPP-A)
and free β-subunit of choriogonadotropin (free
β-HCG) in serum with nuchal translucency
(NT) diameter (combined test), the possibility
of detecting trisomy 21 rises up to 90.0% with
5.0% false-positive findings [2]. The testing was done between 11 and 13+6 weeks of gestation. If
the result happened to be positive, some invasive
methods of prenatal diagnosis were suggested to
the pregnant woman. A limit value of the combined
test was 1: 250. A special problem was the test
result interpretation. According to the literature,
32.0% of pregnant women did not know what the
term “high risk” meant after getting the results and
talking to the doctor [3]. The research objective
was: 1) to examine the sensitivity and specificity
of ultrasonographic (NT) and biochemical (free
β-HCG and PAPP-A) markers as parameters of the
combined test, and amniocentesis in diagnostics
of congenital fetal anomalies; and 2) to set the
credibility ratio of the combined test results.
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