title: CINtec® PLUS dual immunostain: a triage tool for cervical pap smears with atypical squamous cells of undetermined significance and low grade squamous intraepithelial lesion.
abstract: ASC and LSIL comprise the majority of abnormal Pap smears. Currently, high-risk human papillomavirus testing is utilized to triage women with ASC for colposcopy; however, no cost effective triage method is available for LSIL. p16 and Ki-67 have each been shown to be good biomarkers for high grade cervical intraepithelial neoplasia (HG CIN).We evaluated the role of the CINtec® PLUS p16/Ki-67 dual immunostain as a marker for underlying (U) or subsequent (S) HG CIN. One hundred and eighty eight cervical SurePath Pap smears with histological and/or cytological follow-up were retrieved from our departmental files. The Pap stained slides were destained and then immunostained utilizing the CINtec® PLUS dual staining reagent kit. Results of the dual stain were correlated with follow-up diagnoses. Sensitivity, specificity, and positive and negative predictive values of CINtec® PLUS for U or S HG CIN were compared with those of HR HPV testing and with p16 and Ki-67 immunostaining alone. The sensitivity of CINtec® PLUS for U or S HG CIN was 91% in the ASC group and 100% in the LSIL group, while the corresponding specificities were 61 and 43%, respectively. The sensitivity and specificity of CINtec® PLUS for U or S HG CIN in both groups combined were 97 and 53%, respectively. CINtec® PLUS was more specific than HR HPV testing and Ki-67 and p16 immunostains alone in detecting an U or S HG CIN. CINtec® PLUS is a helpful adjunct in identifying U or S HG CIN when applied to SurePath Pap smears with ASC or LSIL.
authors: Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles, CA 90048, USA. sanam.loghavi@cshs.org
authors: Sanam
authors: S
authors: Loghavi
authors: Ann E
authors: AE
authors: Walts
authors: Shikha
authors: S
authors: Bose
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000378:metabolism; D005260:Female; D006801:Humans; D019394:Ki-67 Antigen / Q000378:metabolism; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications / Q000473:pathology; D012680:Sensitivity and Specificity; D014218:Triage / Q000379:methods*; D002578:Uterine Cervical Dysplasia / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000821:virology; D014626:Vaginal Smears / Q000379:methods*; D055815:Young Adult
chemical_list: D014408:Biomarkers, Tumor; D019394:Ki-67 Antigen