title: Comparison of the sensitivities of three commercial assays for detection of the high risk HPV types 16, 18 and 45.
abstract: The relative and analytical sensitivity of the APTIMA HPV test (AHPV, broad-spectrum, target amplification) and the PreTect HPV-Proofer (type-specific, target amplification) for the detection of HPV mRNA in various cell lines was compared. Equivalent relative sensitivity for the HPV 16-containing cell lines (2.5 cells/ml with both CaSki and SiHa) was observed for the mRNA assays--and similar sensitivities were observed for the detection of HPV 18 (HeLa) and 45 (MS751); ranging from 2.5 cells/ml (Proofer) to 25 cells/ml (APTIMA). In relation to analytical sensitivity, again, the mRNA assays showed similar sensitivities to each other, ranging from 0.1 to 1 cell per reaction for APTIMA and 0.1 to 10 cells per reaction for PreTect HPV-Proofer (depending on cell line). Both mRNA assays consistently achieved a higher analytical sensitivity than a DNA based comparator--the Hybrid Capture 2 High-Risk HPV DNA test (hc2). This study indicates that mRNA tests had high analytical sensitivity, higher than a well established DNA-test based when using cell lines as target. Implications for clinical application are discussed.
authors.affiliation: Scottish HPV Reference Laboratory, Royal Infirmary of Edinburgh, EH16 4SA, United Kingdom. Kate.Cuschieri@luht.scot.nhs.uk
authors.forename: Kate
authors.initials: K
authors.lastname: Cuschieri
authors.forename: Alison
authors.initials: A
authors.lastname: Hardie
authors.forename: Siri
authors.initials: S
authors.lastname: Hovland
authors.forename: Bente
authors.initials: B
authors.lastname: Hoaas
authors.forename: Frank
authors.initials: F
authors.lastname: Karlsen
authors.forename: Heather
authors.initials: H
authors.lastname: Cubie
mesh_terms: D002460:Cell Line; D005260:Female; D006801:Humans; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D012333:RNA, Messenger / Q000032:analysis / Q000235:genetics; D012367:RNA, Viral / Q000032:analysis / Q000235:genetics; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*
chemical_list: D012333:RNA, Messenger; D012367:RNA, Viral
keywords: APTIMA; HPV; PreTect HPV-Proofer; Sensitivity; hc2