The Evaluation of Domestic Immunoradiometric Assay Kit for Alpha-fetoprotein.
- Author:
Kyoung Sook WON
;
Jin Sook RYU
;
Dae Hyuk MOON
;
Hee Kyung LEE
- Publication Type:Original Article
- Keywords:
Alpha-fetoprotein;
Domestic;
Immunoradiometric assay
- MeSH:
alpha-Fetoproteins*;
Fetal Proteins;
Immunoradiometric Assay*;
Korea;
Radioimmunoassay;
Seoul;
Biomarkers, Tumor
- From:Korean Journal of Nuclear Medicine
2000;34(4):353-359
- CountryRepublic of Korea
- Language:Korean
-
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.
