title: Agreement between the AMPLICOR Human Papillomavirus Test and the Hybrid Capture 2 assay in detection of high-risk human papillomavirus and diagnosis of biopsy-confirmed high-grade cervical disease.
abstract: The AMPLICOR HPV test (AMP) and the Hybrid Capture 2 assay (HC2) detect 13 high-risk human papillomavirus (HR-HPV) types. Evaluation of comparative performance with clinical samples is needed to allow informed implementation of AMP into clinical practice. AMP was used (i) to assess the prevalence of HR-HPV in 1,032 samples of known cytology, HC2 status, and/or confirmed histology; (ii) to determine agreement between AMP and HC2; (iii) to evaluate the clinical sensitivity and specificity for detecting HR-HPV; and (iv) to detect the presence of biopsy-confirmed high-grade cervical intraepithelial neoplasia. The prevalence of HR-HPV was 39.3% and 45.6% by AMP and HC2, respectively. Overall agreement was 89.2% (kappa value, 0.78). Of 509 HR-HPV-negative specimens by HC2, 488 (95.9%) were AMP negative. Of 427 HR-HPV-positive specimens by HC2, 347 (81.2%) were AMP positive. In comparing the ability to detect high-grade squamous intraepithelial lesions (HSIL), the two tests were positive for all HSIL samples. Both tests performed similarly on CIN2+ samples (clinical sensitivities were 96.7% and 97.8%, respectively, for AMP and HC2). The clinical specificities of AMP and HC2 were comparable (54.9% versus 51.6%; P=0.18). Genotyping of 20 HC2-negative/AMP-positive cases using alternative technologies revealed target HR genotypes in 63.1% of cases and low-risk types in 15.7% of cases, while 21% of cases were negative. In conclusion, AMP provides a viable alternative to HC2, with good agreement for samples with high-grade cytology and similar sensitivity in detecting CIN2+ lesions.
authors.affiliation: Centro per lo Studio e la Prevenzione Oncologica, Unità Operativa Citologia Analitica e Molecolare, Via Cosimo il Vecchio 2, 50127 Firenze, Italy. f.carozzi@cspo.it
authors.forename: Francesca
authors.initials: F
authors.lastname: Carozzi
authors.forename: Simonetta
authors.initials: S
authors.lastname: Bisanzi
authors.forename: Cristina
authors.initials: C
authors.lastname: Sani
authors.forename: Marco
authors.initials: M
authors.lastname: Zappa
authors.forename: Silvia
authors.initials: S
authors.lastname: Cecchini
authors.forename: Stefano
authors.initials: S
authors.lastname: Ciatto
authors.forename: Massimo
authors.initials: M
authors.lastname: Confortini
mesh_terms: D000230:Adenocarcinoma / Q000175:diagnosis* / Q000821:virology; D000328:Adult; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000821:virology; D002584:Cervix Uteri / Q000821:virology; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic