Alpha-Fetoprotein (AFP) is normally produced during fetal and neonatal development by the liver, yolk sac and in small concentrations by the gastrointestinal tract. By the second year of life, AFP concentrations decrease rapidly, and thereafter only trace amounts are normally detected in serum. In general, normal adults have serum AFP concentrations of less than 10 ng/mL.  Elevated AFP levels occur in several malignant diseases including hepatocellular carcinoma, testicular nonseminomatous origin, and occasionally of other entodermal origin. AFP has also been used to detect early tumors in people at high risk for liver cancer. Studies of patients with large hepatic metastases or viral hepatitis also indicate slightly elevated or persistent AFP values. In areas where liver cancer is common, the use of AFP tests for screening has resulted in the detection of many tumors at an earlier stage. Detection of elevated AFP levels can also be used in the detection of fetal open neural tube defects.

The AFP Rapid Test (Whole Blood/Serum/Plasma) utilizes a combination of anti-AFP antibody coated particles and anti-AFP antibodies to detect elevated levels of AFP in whole blood, serum or plasma. The minimum detection level is 10 ng/mL.