Clinical application assessment of high-throughput enzyme-linked immunosorbent assay for serum alpha fetoprotein

Abstract

Objective To evaluate the clinical application of serum alpha fetoprotein (AFP) assay by high-throughput enzyme-linked immunosorbent assay(ELISA). Methods A total of 184 serum samples of patients (hepatic carcinoma, hepatitis and hepatic cirrhosis patients) and 200 serum samples of healthy people were recruited.The repeatability and accuracy were estimated.Compared with the electrochemiluminescence immunoassay (ECLIA) and evaluated the clinical value of high-throughput ELISA. Results The total coefficient of variation(CV) of four kinds of AFP concentration were 13.1%、13.7%、11.4%、10.3%, respectively.The accuracy test PT=100%.The linear range of high-throughput ELISA for AFP was(0.0~200.0)μg/L.The results between high-throughput ELISA and ECLIA was linear (Y=1.14X+ 0.83, R2=0.92). The positive rate of high-throughput ELISA and ECLIA were 67.39% and 69.02%, respectively.No statistically significant difference was found in positive rate of the two methods(P=0.453). The diagnostic threshold of primary liver cancer was 195.7 μg/L.The diagnostic threshold between primary liver cancer and metastatic liver cancer was 99.44 μg/L.The diagnostic threshold between primary liver cancer and hepatitis or liver cirrhosis was 379.15 μg/L. Conclusions High-throughput ELISA assay for quantitation of serum AFP is an accurate and stable performance in screening and diagnosis of primary liver cancer. Key words: Alpha fetoprotein; High-throughput ELISA; Quantitative analysis; Clinical application assessment