Stepwise algorithm combining HPV high-risk DNA-based assays and RNA-based assay for high grade CIN in women with abnormal smears reffered to colposcopy

Article type: Research Article

Authors: Halfon, Philippe^{a; c; *} | Benmoura, Dominique^{a; b} | Agostini, Aubert^b | Khiri, Hacène^c | Pénaranda, Guillaume^{c; d} | Martineau, Agnès^a | Blanc, Bernard^a

Affiliations: [a] Hôpital Ambroise Paré, Marseille, France | [b] Hôpital La Conception, Marseille, France | [c] Laboratoire Alphabio, Marseille, France | [d] CDL Pharma, Marseille, France

Correspondence: [*] Corresponding author: Philippe Halfon, Laboratoire Alphabio, 23 Rue de Friedland, 13006 Marseille, France. Tel.: +33 4 91 25 41 00; Fax: +33 4 91 79 20 44; E-mail: [email protected].

Abstract: Background:The detection of high-risk human papillomavirus (HPV) DNA provides higher sensitivity but lower specificity than cytology for the identification of high-grade cervical intraepithelial neoplasia (CIN). Objectives:The aim of this study was to combine DNA- and RNA-based assays in order to improve the detection of advanced disease (CIN2+). Methods:107 ASCUS+ women were included in Marseilles (France) between March 2007 and June 2008. Up to five tests were carried out on a liquid PreservCyt sample: Hybrid Capture 2 (HCII) (Digene), Papillocheck (Greiner), Abbott RealTime HR HPV (RT HR HPV) (Abbott), Linear Array (Roche), and EasyQ HPV (Biomérieux). Results:36 (34%) women had CIN2+ histology; among them 6 (6%) had CIN3+ histology. For CIN2+ detection, all tests had comparable sensitivities except EasyQ HPV test: HCII 94%, Papillocheck and LA 92%, RT HR HPV 89%, and NucliSENS EasyQ HPV 75% (P not significant). On the other hand, EasyQ HPV had a higher specificity than the other assays (except RT HR HPV assay). Combining DNA-based and RNA-based assay would allow to reduce the need of colposcopies to be performed among patients HPV positive with DNA-based assay: 32% (7/22) colposcopies not needed in < 30 years old patients, and 29% (14/49) colposcopies not needed in ⩾ 30 years patients. Conclusions:All tests had comparable diagnostic values for CIN2+ detection, but DNA-based tests seemed to be more sensitive and RNA-based assay more specific. The combined use of DNA- and RNA-based assays considerably reduces the number of colposcopies to be performed, and provides better diagnostic accuracy for CIN2+ disease.

Keywords: DNA-based assays, RNA-based assays, colposcopy, stepwise algorithm

DOI: 10.3233/CBM-2010-0156

Journal: Cancer Biomarkers, vol. 7, no. 3, pp. 133-139, 2010