title: Performance of human papillomavirus DNA and mRNA testing strategies for women with and without cervical neoplasia.
abstract: In the present study we investigated the cross-sectional positivity for DNA and E6/E7 mRNA from high-risk human papillomavirus (HPV) types in 643 women with high-grade cervical neoplasia (135 cases of cervical intraepithelial neoplasia grade 2 [CIN2], 495 cases of CIN3/adenocarcinoma in situ [ACIS], and 13 cases of invasive carcinoma) and in 736 women with normal cytology by using the Amplicor and PreTect HPV-Proofer assays. In addition, genotyping was performed using Linear Array for women with normal cytology and a positive HPV test and in all women with histologically confirmed CIN2+. 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 the Amplicor and PreTect HPV-Proofer tests 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 types 16, 18, 33, and 45. HPV type 16 and/or 18 was detected in 58.8% (378/643) of the women with high-grade neoplasia. Detection of E6/E7 mRNA by PreTect HPV-Proofer increased with 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.
authors.affiliation: Department of Obstetrics and Gynecology, Akershus University Hospital, Lørenskog, Norway. ameli.trope@me.com
authors.forename: Ameli
authors.initials: A
authors.lastname: Tropé
authors.forename: Katrine
authors.initials: K
authors.lastname: Sjøborg
authors.forename: Anne
authors.initials: A
authors.lastname: Eskild
authors.forename: Kate
authors.initials: K
authors.lastname: Cuschieri
authors.forename: Tormod
authors.initials: T
authors.lastname: Eriksen
authors.forename: Steinar
authors.initials: S
authors.lastname: Thoresen
authors.forename: Martin
authors.initials: M
authors.lastname: Steinbakk
authors.forename: Vigdis
authors.initials: V
authors.lastname: Laurak
authors.forename: Christine M
authors.initials: CM
authors.lastname: Jonassen
authors.forename: Unni
authors.initials: U
authors.lastname: Westerhagen
authors.forename: Morten B
authors.initials: MB
authors.lastname: Jacobsen
authors.forename: Agnes Kathrine
authors.initials: AK
authors.lastname: Lie
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004279:DNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D009856:Oncogene Proteins, Viral / Q000096:biosynthesis* / Q000235:genetics*; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification*; D011933:Reagent Kits, Diagnostic; D014594:Uterine Neoplasms / Q000473:pathology / Q000821:virology*; D055815:Young Adult
chemical_list: D004279:DNA, Viral; D009856:Oncogene Proteins, Viral; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic