title: Sensitivity of APTIMA HPV E6/E7 mRNA test in comparison with hybrid capture 2 HPV DNA test for detection of high risk oncogenic human papillomavirus in 396 biopsy confirmed cervical cancers.
abstract: The sensitivity of E6/E7 mRNA-based Aptima HPV test (AHPV; Hologic, Inc.) for detection of cervical cancer has been reported based on only a small number of cases. We determined the sensitivity of AHPV in comparison with the DNA-based Hybrid Capture 2 HPV test (HC2; Qiagen) for the detection of oncogenic HPV in a large number of cervical cancers at the time of diagnosis using cervical samples obtained in ThinPrep (Hologic). Samples yielding discordant results were genotyped using Linear Array assay (LA; Roche). Of 396 cases tested, AHPV detected 377 (sensitivity, 95.2%; 95%CI: 93.1-97.3), and HC2 376 (sensitivity, 94.9%; 95%CI: 92.7-97.1) with an agreement of 97.2% (kappa 0.7; 95%CI: 0.54-0.87). Among six AHPV+/HC2- cases, LA identified oncogenic HPV types in four including a type 73 and was negative in two. Among five AHPV-/HC2+ cases, LA detected oncogenic HPV types in two including a type 73 and was negative in three. Of 14 AHPV-/HC2- cases, 13 were genotyped. LA detected oncogenic HPV types in six, non-oncogenic types in three, and was negative in four. This is the largest study to demonstrate the sensitivity of AHPV for the detection of invasive cervical cancer and this assay showed equal sensitivity to HC2.
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Partha
authors.initials: P
authors.lastname: Basu
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Dipanwita
authors.initials: D
authors.lastname: Banerjee
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Srabani
authors.initials: S
authors.lastname: Mittal
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Sankhadeep
authors.initials: S
authors.lastname: Dutta
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Ishita
authors.initials: I
authors.lastname: Ghosh
authors.affiliation: Chittaranjan National Cancer Institute, Kolkata, India.
authors.forename: Nilarun
authors.initials: N
authors.lastname: Chowdhury
authors.affiliation: Department of Clinical Virology, Christian Medical College, Vellore, India.
authors.forename: Priya
authors.initials: P
authors.lastname: Abraham
authors.affiliation: Department of Molecular Oncology, AceProbe Technologies (India) Pvt. Ltd, New Delhi, India.
authors.forename: Puneet
authors.initials: P
authors.lastname: Chandna
authors.affiliation: Memorial University, St. John's, Newfoundland and Labrador, Canada.
authors.forename: Sam
authors.initials: S
authors.lastname: Ratnam
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D004279:DNA, Viral / Q000302:isolation & purification*; D055088:Early Detection of Cancer; D005260:Female; D005838:Genotype; D061809:Human Papillomavirus DNA Tests / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000821:virology*; D012333:RNA, Messenger; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis / Q000821:virology*
chemical_list: D004279:DNA, Viral; D012333:RNA, Messenger; D011933:Reagent Kits, Diagnostic
keywords: HPV; aptima; carcinoma cervix; cervical cancer screening; hybrid capture 2; linear array