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  • 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.
    Author: Loghavi S, Walts AE, Bose S.
    Journal: Diagn Cytopathol; 2013 Jul; 41(7):582-7. PubMed ID: 22833355.
    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.
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