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Each of the 2 test data sets was used to create new parameter estimates against which screening test performance was assessed using the other data set.

The results were equivocal but there was evidence suggesting improvement in screening performance through the use of repeated measures of PAPP-A when the first trimester sample was collected before 13 weeks' gestation.

There was no evidence of any benefit from repeated measures of h CG or u E3.

The National Institutes of Health sponsored a multi-center prospective study (the First and Second Trimester Evaluation of Aneuploidy Risk or 'FASTER' trial) that compared first- and second-trimester non-invasive methods of screening for fetal aneuploidies with second trimester multiple marker maternal serum screening that is the current standard of care (NICHD, 2001).

The results of the FASTER trial are described in CPB 282 - Noninvasive Down Syndrome Screening.

See also CPB 0140 - Genetic Testing, and CPB 0282 - Noninvasive Down Syndrome Screening.

Levels of human chorionic gonadotropin (h CG), maternal serum alpha-fetoprotein (MSAFP), and unconjugated estriol have been associated with maternal risk of Down syndrome, a chromosomal abnormality associated with mental retardation, congenital heart defects, and physical anomalies.

Measurement of multiple serum markers offers a means of identifying young women who are at high-risk of having a Down syndrome fetus; women found to be at high-risk would be offered confirmatory testing by karyotyping tissue obtained by amniocentesis or CVS.

Multiple marker testing may also allow pregnant women at high-risk (such as pregnant women age 35 and older) an alternative means of determining the likelihood of having a Down syndrome fetus if they wish to avoid the risk of fetal harm and death associated with amniocentesis and CVS.Efforts to improve biochemical screening have centered on the investigation of screening in the first trimester and on the search for better markers.Two potential serum markers that can be measured during the first trimester are the free beta subunit of h CG and pregnancy-associated protein A.Dimeric inhibin A is now used by some commercial laboratories in combination with the 3 traditional analytes.With a screen-positive rate of 5 % or less, this new 4-analyte combination appears to detect 67 % to 76 % of Down syndrome cases in women younger than 35 years (ACOG, 2001).Serum concentrations of the free beta subunit of h CG are higher than average, and pregnancy-associated protein A concentrations are lower, in the presence of a fetus with Down syndrome.

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