Trial Information

Nano-mechanical and Nano-electrosensing Devices Based Interaction Force and Interaction Kinetics Analysis of Oncogenic Human Papilloma Viruses

Human papillomavirus (HPV)-induced cervical carcinogenesis is proposed to be multi-step in
nature. The major steps in cervical carcinogenesis include persistent infection of the
metaplastic cervical epithelium with one or more of the oncogenic HPV infection, clonal
progression of the infected epithelium to cervical precancer, and further invasion. Although
these fundamental steps are well established, several new genetic and immunologic studies
have shed light on the factors that influence each of these transitions. Over 150 different
HPV subtypes have been identified so far, with a subset of these being classified as high
risk for oncogenesis. Persistent infection with oncogenic HPV is the main cause of cervical
cancer. Polymerase-chain-reaction (PCR)-based assays show that HPV DNA exist in around 90.7-
96.6% patients with cervical cancer and in 13.4 -15.6% control women. About the detected HPV
types in patients, in descending order of frequency, are types 16, 18, 45, 31, 33, 52, 58,
and 35. Fifteen HPV types are classified as high-risk types (16, 18, 31, 33, 35, 39, 45, 51,
52, 56, 58, 59, 68, 73, and 82); 3 are classified as probable high-risk types (26, 53, and
66); and 12 are classified as low-risk types (6, 11, 40, 42, 43, 44, 54, 61, 70, 72, 81).
The most frequently detected high risk HPV types (HPV 16, 51, 52, and 59) are similar in
male of different sites, which is compatible with the female incidence.

Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and
sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used
for analyzing the interaction kinetics between anti-high risk HPV and its antigen (high-risk
HPV) present in patients. The system incorporates the use of engineered semiconducive
antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through
(eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound
as a suitable electrosensing probe, which specifically and selectively binds targeted
molecules (high-risk HPV) in the test specimens. From assessment of the electric signature
of semiconductive anti- high-risk HPV antibodies, the eABprobe could offer sensitive
detection and precise quantification of high-risk HPV.

To develop a real-time diagnostic technique with e- Ab sensor for high risk HPV detection,
the investigators conduct a prospective clinical study. In comparison with results from
direct sequencing of HPV, the investigators evaluate the performance of e- Ab sensor,
including reproducibility, sensitivity, specificity, and cross-reaction (such as detection
of low risk HPV). The potential factors which may interfere with the results would be
investigated. e- Ab sensor threshold decisions must maximize its sensitivity. Therefore, the
threshold value in the test group is to find the decision could have 90% sensitivity and 90%
specificity.With such a real-time diagnostic technique, the investigators hope to obtain
information of patients in cost-saving and time-saving way and can give patients early
treatment and offer more individualized treatment for our patients.