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  • Immunoassay reagents intended to perform qualitative and/or quantitative analyses of a sample of body fluids (e.g., maternal and fetal serum, amniotic fluid) to determine alpha-fetoprotein (AFP), a fetal glycoprotein secreted during pregnancy, initially by the fetal yolk sac and later by the fetal liver. Abnormally high levels of AFP in maternal serum are associated with many conditions, including fetal open neural tube defects such as anencephaly and spina bifida (meningomyelocele); low levels are found in conditions such as trisomy-21 (Down\'s syndrome) and trisomy-18 pregnancies. AFP is secreted after birth by neoplastic tumor cells (i.e., a tumor marker). High levels (typically greater than 1,000 microgram/liter) are indicative of hepatocellular carcinoma; the level of AFP is used for prognosis and monitoring of hepatocellular carcinoma.
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