title: Diagnostic performance of dual-staining cytology for cervical cancer screening: A systematic literature review.
abstract: Cervical cancer screening saves lives. Secondary prevention in cervical cancer screening relies on the results of primary cytology and/or HPV testing. However, primary screening with cytology has a low sensitivity, and HPV screening has a low specificity. This means that either cancers are missed, or women are over-treated. To improve performance outcomes, the concept of dual-stain cytology (CINtec®PLUS Cytology test) has been introduced. In this approach, additional staining with p16/Ki-67 is performed in cases where cytology results are abnormal (LSIL or ASCUS) and/or HPV-positive. Another way to describe this approach might be "diagnostic" cytology. In order to assess the value of this "diagnostic cytology", a systematic literature review was conducted of dual-stain cytology performance across multiple studies until May 2016. In a Belgian screening population (women age 25-65 years), dual-stain cytology was significantly more sensitive (66%) and slightly less specific (-1.0%) than cytology. In the population referred to colposcopy or with abnormal cytology (ASCUS, LSIL), dual-staining showed a significantly higher increase in specificity, and a slightly lower sensitivity than HPV testing. Specificity gains resulted in fewer false positives and an increase in the number of correct referrals to colposcopy. Dual-staining with p16/Ki-67 cytology is an attractive biomarker approach for triage in cervical cancer screening.
authors.affiliation: Multidisciplinary Breast Clinic, Unit Gynecologic Oncology, Antwerp University Hospital, University of Antwerp, Wilrijkstraat 10, 2650 Edegem, Belgium. Electronic address: Wiebren.Tjalma@uza.be.
authors.forename: Wiebren A A
authors.initials: WAA
authors.lastname: Tjalma
mesh_terms: D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000032:analysis*; D003584:Cytological Techniques; D005260:Female; D006801:Humans; D019394:Ki-67 Antigen / Q000032:analysis*; D008403:Mass Screening; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears
chemical_list: D019941:Cyclin-Dependent Kinase Inhibitor p16; D019394:Ki-67 Antigen
keywords: ASCUS (abnormal squamous cells of undetermined significance); CINtec(®) PLUS cytology test; Diagnostic cytology; Dual-stain cytology; Ki-67; LSIL (low-grade squamous intraepithelial lesion); Screening; Triage; p16; p16/Ki-67 dual-stain cytology