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Annals of Clinical Biochemistry

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This version was published on 1 March 2009
Ann Clin Biochem 2009;46:117-122
doi:10.1258/acb.2008.008129
© 2009 Association for Clinical Biochemistry

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Original Articles

Novel automated pulse immunoassay for human alpha-fetoprotein

Keisuke Iwata1, Yukitoshi Kanayama1, Tadayuki Sahara1, Isao Karube2, Nobuo Inaba3, Shinji Fujino3, Mikihiko Kawano3 and Ikunosuke Sakurabayashi3


1 R&D Division, Pulse ImmunoTech Corporation, Katayanagi Institute, Tokyo University of Technology, 1404-1 Katakura, Hachioji, Tokyo 192-0982; 2 School of Bioscience and Biotechnology, Tokyo University of Technology, 1404-1 Katakura, Hachioji, Tokyo 192-0982; 3 Department of Graduate Medical Education, Jichi Medical University, Saitama Medical Center, 1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama 330-8503, Japan


Corresponding author: Keisuke Iwata. Email: iwata{at}pit-jp.com

Background: To improve current alpha-fetoprotein (AFP) assays, which are expensive and time-consuming, a specific AFP reagent has been developed for practical use in our newly developed high-speed, highly sensitive pulse immunoassay (PIA) system, in which a latex immunoagglutination reaction is carried out under a high-frequency pulse voltage, leading to an enhanced immunological reaction.

Methods: We evaluated the assay performance (reproducibility, sensitivity, dilution linearity, interference) of the newly developed automated AFP PIA compared with the current AFP assay.

Results: Using pooled serum samples, the within-run reproducibility resulted in a correlation variation of 3.6–4.7%. The AFP assay detection limit was determined to be 2.5 µg/L. Linear sequential dilution was found up to nearly 700 µg/L. Even up to an AFP concentration of 1.0 g/L, the prozone phenomenon was not observed. Free and conjugated bilirubin, haemolytic haemoglobin, chyle and rheumatoid factor did not show any test interference. Using AFP-positive serum samples from 114 patients, the correlation between our PIA and a chemiluminescence immunoassay resulted in an excellent correlation coefficient of 0.994.

Conclusions: The performance of AFP reagents in the PIA device shows that the system has excellent speed and equal sensitivity and specificity compared with the most highly sensitive conventional method. Our PIA system thus appears ready for use in the clinical diagnosis setting.


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