The Evaluation of Domestic Immunoradiometric Assay Kit for Alpha-fetoprotein

Won, Kyoung Sook; Ryu, Jin Sook; Moon, Dae Hyuk; Lee, Hee Kyung

Abstract

PURPOSE: Although alpha-fetoprotein is one of the most commonly used tumor markers in Korea, most of the radioimmunoassay kits for alpha-fetoprotein have been imported from foreign countries. The purpose of this study was to evaluate the performance of a recently developed domestic immunoradiometric kit for alpha- fetoprotein (Riakey AFP IRMA CTR, Sin-Jin Medics, Seoul, Korea). MATERALS AND METHODS: We evaluated intra- and inter-assay precision, recovery rate, parallelism, and sensitivity of serum alpha-fetoprotein measurement using Riakey AFP IRMA CTR kit. The values of alpha-fetoprotein measured by Riakey AFP IRMA CTR kit were compared with those measured by two foreign commercial kits (alpha-fetoproteina of Radim and alpha-feto.riabead of Abbott).
RESULTS
Intra-assay coefficients of variation on three different levels were 5.3% for 18.9 ng/ml, 3.4% for 133 ng/ml and 1.6% for 330 ng/ml. Inter-assay coefficients of variation were 9.7% for 20.9 ng/ml, 3.2% for 137 ng/ml and 4.1% for 330 ng/ml respectively. Recovery rate tests on all three different levels showed within 100+/-10%. Parallelism was also good and the sensitivity was 0.63 ng/ml. There was strong correlation between the measurement of alpha-fetoprotein by Riakey AFP IRMA CTR and that by two foreign commercial kits(r=0.98).
CONCLUSION
The first Korean domestic immunoradiometric kit for alpha-fetoprotein, Riakey AFP IRMA CTR, performed well for clinical use.