Hpv e6, e7 mrna assay and methods of use thereof

Details Hpv e6, e7 mrna assay and methods of use thereof Hpv e6, e7 mrna assay and methods of use thereof

C - Chemistry, Metallurgy

12

Q

C12Q 1/68 (2006.01) C12Q 1/70 (2006.01)

Patent

CA 2596792

Provided is an HPV E6, E7 mRNA assay, referenced herein as the "In Cell HPV Assay," that is capable of sensitive and specific detection of normal cervical cells undergoing malignant transformation as well as abnormal cervical cells with pre-malignant or malignant lesions. The In Cell HPV Assay identifies HPV E6, E7 mRNA via in situ hybridization with oligonucleotides specific for HPV E6, E7 mRNA and quantitates the HPV E6, E7 mRNA via flow cytometry. The In Cell HPV Assay can be carried out in less than three hours directly from liquid-based cervical ("LBC") cytology specimens. The In Cell HPV Assay provides an efficient and highly sensitive alternative to the Pap smear for determining abnormal cervical cytology.

L'invention concerne un dosage d'ARNm d'E6, E7 d'HPV, appelé "dosage cellulaire d'HPV", permettant de détecter, de manière sensible et spécifique, des cellules cervicales normales subissant une transformation maligne et des cellules cervicales anormales possédant des lésions malignes ou pré-malignes. Ce dosage cellulaire d'HPV permet d'identifier l'ARNm d'E6, E7 d'HPV par l'hybridation in situ avec des oligonucléotides spécifiques à l'ARNm d'E6, E7 d'HPV et de quantifier l'ARNm d'E6, E7 d'HPV par cytométrie en flux. Ce dosage cellulaire d'HPV peut être effectué en moins de trois jours, directement à partir de spécimens de cytologie cervicale en milieu liquide. Ledit dosage cellulaire d'HPV fournit une alternative efficace et hautement sensible au frottis de Papanicolaou permettant de déterminer une cytologie cervicale anormale.

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