Detection of the p53 tumor suppressor gene is important in early cancer dia
gnostics because alterations in the gene have been associated with carcinog
enic manifestations in several tissue types in humans. We have developed an
antibody-based detection instrument, the biochip, to detect the presence o
f the anti-p53 antibody in human serum. The design of this highly integrate
d detector system is based on miniaturized phototransistors having multiple
optical sensing elements, amplifiers, discriminators, and logic circuitry
on an IC board. The system utilizes laser excitation and fluorescence signa
ls to detect complex formation between the p53 monoclonal antibody and the
p53 antigen. Recognition antibodies are immobilized on a nylon membrane pla
tform and incubated in solutions containing antigens labeled with Cy5, a fl
uorescent cyanine dye. Subsequently, this membrane is placed on the detecti
on platform of the biochip and fluorescence signal is induced using a 632.8
-nm He-Ne laser. Using this immuno-biochip, we have been able to detect bin
ding of the p53 monoclonal antibody to the human p53 cancer protein in biol
ogical matrices. The performance of the integrated phototransistors and amp
lifier circuits of the biochip, previously evaluated through measurement of
the signal output response for various concentrations of fluorescein-label
ed molecules, have illustrated the linearity of the microchip necessary for
quantitative analysis. The design of this biochip permits sensitive, selec
tive and direct measurements of a variety of antigen-antibody formations at
very low concentrations. Furthermore, the acquisitions of the qualitative
and quantitative results are accomplished rapidly, in about 15 min. These f
eatures demonstrate the potential. of this antibody-based biochip for simpl
e, rapid and early biomedical diagnostics of cancer.