[Clinical evaluation on an enzyme immunoassay kit for basic fetoprotein (BFP). (1) Clinical usefulness of BFP]

Clinical usefulness of a sandwich enzyme immunoassay kit for basic fetoprotein (BFP), which has been developed with two kinds of monoclonal anti-BFP by Nippon Kayaku Co., LTD., was evaluated on detection of BFP in the sera. Based on the consideration of BFP-positive rate under 5% in healthy donors and diagnostic efficiency for cancer, a BFP-concentration of 75ng/ml was used as the cut off value. BFP in the sera was positive in 3.5% of 368 healthy donors, 18.2% of 549 patients with benign diseases and 45.3% of 870 patients with cancer. High positive rates of 50 approximately 60% for the serum BFP were found in cancer of the liver, bile duct, pancreas, kidney, prostate, testis and ovary. In early cancer of the bile duct and urogenital organs, high BFP-positive rates beyond 46% were recognized. BFP values in 7 of 9 BFP-positive patients with urogenital cancer fell down to negative serum level after the radical operation. These results indicate that BFP is a tumor marker with widespread representation in cancer and contributes to serological diagnosis for cancer of digestive and urogenital systems, particularly for early cancer of these systems. Furthermore, it is suggested that BFP is useful for monitoring of cancer patients after surgery.