Novel automated pulse immunoassay for human alpha-fetoprotein.
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 microg/L. Linear sequential dilution was found up to nearly 700 microg/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.
Iwata
Keisuke
K
R&D Division, Pulse ImmunoTech Corporation, Katayanagi Institute, Tokyo University of Technology, Hachioji, Tokyo, Japan. iwata@pit-jp.com
Kanayama
Yukitoshi
Y
Sahara
Tadayuki
T
Karube
Isao
I
Inaba
Nobuo
N
Fujino
Shinji
S
Kawano
Mikihiko
M
Sakurabayashi
Ikunosuke
I
D006801:Humans; D007118:Immunoassay / Q000295:instrumentation / Q000379:methods*; D007841:Latex Fixation Tests / Q000295:instrumentation / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D035501:Uncertainty; D000509:alpha-Fetoproteins / Q000032:analysis*
C097353:AFP protein, human; D000509:alpha-Fetoproteins