AFP Reagent – Jaj International

The concentration of alpha-fetoprotein (AFP) in a given specimen, determined with assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the AFP assay used. Values obtained with different assay methods cannot be used interchangeably.

If, in the course of monitoring a patient, the assay method used for determining AFP levels serially is changed, additional sequential testing should be carried out. Prior to changing assays, the laboratory MUST:
1. For Cancer Management – Confirm baseline values for patients being serially monitored.
2. For Prenatal Testing – Establish a range of expected values for the new assay based on serum or plasma
and amniotic fluid from pregnant women with confirmed gestational age.

The discovery of alpha-fetoprotein (AFP) in fetal serum was first recorded by Bertrand and Czar in 1956.1 Alpha-fetoprotein is a single polypeptide chain glycoprotein with a molecular weight of approximately 70,000 Daltons. The physicochemical properties and amino acid composition are similar to those of albumin.2,3 Synthesis of AFP occurs primarily in the liver and yolk sac of the fetus. It is secreted into fetal serum, reaching a peak at about 13 weeks gestation and gradually declining thereafter. Elevated serum AFP levels subsequently reappear during pregnancy and in conjunction with several malignant diseases.

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