JCM Accepts, published online ahead of print on 17 June 2009

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J. Clin. Microbiol. doi:10.1128/JCM.01863-08
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Performance of human papillomavirus (HPV) DNA and mRNA testing strategies in women with and without cervical neoplasia

Ameli Tropé^*, Katrine Sjøborg, Anne Eskild, Kate Cuschieri, Tormod Eriksen, Steinar Thoresen, Martin Steinbakk, Vigdis Laurak, Christine M. Jonassen, Unni Westerhagen, Morten B. Jacobsen, and Agnes Kathrine Lie

Department of Obstetrics and Gynaecology, Akershus University Hospital, Norway; Department of Obstetrics and Gynaecology, Oestfold Hospital Trust, Norway; Division of Mental Health, Norwegian Institute of Public Health, Oslo, Norway; Faculty of Medicine, University of Oslo, Norway; Specialist Virology Center, Department of Laboratory Medicine Royal Infirmary of Edinburgh of Edinburg, UK; Institute of Population-based Cancer Research, Oslo, Norway; Department of Medical Microbiology, Akershus University Hospital, Lørenskog, Norway; Department of Pathology, Akershus University Hospital, Lørenskog, Norway; Department of Medicine,Oestfold Hospital Trust, Norway

^* To whom correspondence should be addressed. Email: ameli.trope{at}me.com.

In the present study we investigated the cross-sectional positivity of high-risk DNA and E6/E7 mRNA in 643 women with high-grade cervical neoplasia (135 cases of CIN 2, 495 cases of CIN3/ACIS and invasive carcinoma in 13 cases) and in 736 women with normal cytology, by using the Amplicor and PreTect HPV-Proofer assays. In addition, genotyping was performed with Linear Array in women with normal cytology and a positive HPV test and in all women with histologically confirmed CIN 2+. In women with normal cytology; 8.3% (61/736) were Amplicor positive and 3.3% (24/736) were PreTect HPV-Proofer positive (p<0.001). Concordant results between Amplicor and PreTect HPV-Proofer were present in 90.3% (665/736). In women with CIN2+ lesions 96.4% (620/643) were positive by Amplicor, 98.4% (633/643) by Linear Array and 64.1% (412/643) by PreTect HPV-Proofer. Concordant results for the three HPV assays were present in 63.8%. The genotype profile detected by Linear Array and PreTect HPV-Proofer showed substantial agreement for HPV 16, 18, 33 and 45. HPV types 16 and/or 18 were detected in 58.8% (378/643) of the women with high-grade neoplasia. Detection of E6/E7 mRNA by PreTect HPV-Proofer increased by severity of the cervical lesion. Detection of HPV DNA, however, was not associated with histology grade. In conclusion, the detection of HPV varied according to the assay used, and the concordance between the tests was poor. Our results indicate that mRNA testing may be a biomarker for progression of cervical neoplasia, but the optimal genotype mix remains to be determined.

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