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. 1976 Jul 15;295(3):168-9.
doi: 10.1056/NEJM197607152950312.

Sounding board: Antenatal diagnosis, alpha fetoprotein and the FDA

A Milunsky, E Alpert

Sounding board: Antenatal diagnosis, alpha fetoprotein and the FDA

A Milunsky et al. N Engl J Med. .

Abstract

PIP: Elevated amniotic fluid alpha fetoprotein (AFP) levels have been associated with neural tube defects and may be associated with fetal death, omphalocele, and congenital nephrosis. AFP levels determined in 2694 cases where amniotic fluid samples were obtained for routine antenatal genetic studies resulted in the detection of 9 cases (1 in 300) of open neural tube defects. Thus AFP determination is important in every second trimester amniotic fluid sample obtained. However, the U.S. Food and Drug Administration (FDA) banned the commercial distribution of serologic reagents for AFP testing in 1973, thereby limiting availability of AFP assays to a few large centers. The FDA should establish criteria to license AFP reagents immediately so that they may be available for routine use.

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