Applicazione di nuove metodologie alla diagnostica delle infezioni da HPV: valutazione della performance clinica dell’HPV OncoTect rispetto al Nuclisens EasyQ e del suo potenziale ruolo nell’individuazione di lesioni preneoplastiche della cervice uterina
Author(s)
Majolini, Maria Bernardetta
Date Issued
May 31, 2013
Type
Doctoral Thesis
Abstract
In high risk HPVs the expression of the oncoprotein E6 causes the degradation of p53, while E7
inactives the Retinoblastoma protein pRb and causes progression to S phase of cell cycle, both
sustaining the conversion to and the maintenance of malignancy.
The aim of this study was to compare the performance in the detection of the E6 and E7 mRNA
expression of high risk HPV, using the NucliSENS EasyQ test (bioMerieux), a RT-PCR based
method, or HPV OncoTect (IncellDx) a test based on the flow cytometry-FISH method. Moreover,
we investigated the potential role, for the detection of high grade lesion, of the HPV OncoTect
compared to pap smears in an effort to improve cervical cancer screening.
We enrolled 173 patients previously tested positive for hrHPV DNA and/or pap smear and referred
for evaluation by means of the NucliSENS EasyQ test. All patients included in the study were
tested with OncoTect and 87 out of 173 underwent a colposcopy and histological evaluation
according to clinical protocol.
Stratified by cytological grades, the mRNA testing with OncoTect displayed a reactivity of 25% in
negative samples, 40% in ASCUS, 48% in LSIL and 80% in HSIL. The corresponding figures for
NuciliSENS EasyQ assay were 42, 60, 74 and 90%, respectively. Histology analysis revealed that
the sensitivity of OncoTect compared to NucliSENS EasyQ was with normal specimens 20% versus
54%, with CIN1 45% versus 69% and with CIN2+ 74% versus 87%, respectively. Higher
specificity was observed when analysing CIN2+ samples with OncoTect (69%) compared to
NucliSENS EasyQ (36%).
In conclusion, HPV E6/E7 mRNA detected with flow cytometry is more specific than NucliSENS
EasyQ in identifying women with CIN2+ but has a lower sensitivity. HPV OncoTect is a promising
tool for early prediction of persistent HPV infection and seems to be an interesting method to
evaluate the preneoplastic lesions of the cervix and improve cancer screening.
Additional information
Dottorato di ricerca in Genetica e biologia cellulare
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