title: Screening for cervical neoplasia: a community-based trial comparing Pap staining, human papilloma virus testing, and the new bi-functional Celldetect® stain.
abstract: Although cytological screening for cervical neoplasia has lowered mortality rates, current screening methods are plagued by sub-optimal sensitivity and/or specificity. The purpose of this study was to compare the performance of the new CellDetect® staining technology as a potential screening tool. This initial, non-blinded study, utilized samples are taken at a community-based clinic. The diagnostic results using CellDetect® were compared with the performance of Pap staining and human papilloma virus (HPV) testing on the same material, as well as the follow-up biopsies. These data were statistically analyzed in terms of sensitivity, specificity, predictive value (N.P.V and P.P.V), and inter-observer agreement. Bi-functional CellDetect® staining revealed morphological details and tinctorial properties that permitted recognition of neoplasia even at low magnification. Performance-wise, CellDetect® demonstrated non-inferiority for all statistical parameters to both Pap and HPV tests. Importantly, superior sensitivity compared with Pap staining was observed, as well as higher specificity than HPV testing with near equivalent sensitivity. We conclude that CellDetect® is a promising approach to early detection of cervical cancer because of its bi-functional capabilities that afford high sensitivity and specificity. The data suggest that this new methodology warrants further and more extensive clinical evaluation.
authors.affiliation: Zetiq Technologies Ltd., Ramat Gan, Israel. pavel@bio-light.co.il
authors.forename: Pavel
authors.initials: P
authors.lastname: Idelevich
authors.forename: Don
authors.initials: D
authors.lastname: Kristt
authors.forename: Eduardo
authors.initials: E
authors.lastname: Schechter
authors.forename: Sylvia
authors.initials: S
authors.lastname: Lew
authors.forename: Adi
authors.initials: A
authors.lastname: Elkeles
authors.forename: Dov
authors.initials: D
authors.lastname: Terkieltaub
authors.forename: Ilia
authors.initials: I
authors.lastname: Rivkin
authors.forename: Ilan
authors.initials: I
authors.lastname: Bruchim
authors.forename: Ami
authors.initials: A
authors.lastname: Fishman
mesh_terms: D001706:Biopsy; D003151:Community Health Centers; D004279:DNA, Viral / Q000235:genetics*; D055088:Early Detection of Cancer; D005260:Female; D006801:Humans; D015588:Observer Variation; D027383:Papillomaviridae / Q000235:genetics* / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013194:Staining and Labeling; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology; D014626:Vaginal Smears; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000235:genetics / Q000473:pathology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic