title: Usefulness of CINtec® PLUS p16/Ki-67 double-staining in cytological screening of cervical cancer.
abstract: OBJECTIVE
  This study evaluated the usefulness of p16(INK4a)/Ki-67 as a new biomarker in the diagnosis of human papillomavirus (HPV)-related cervical lesions.
  
  
  METHODS
  From 69 women with previous positive cytology, clinician-collected (CC) samples were obtained using a Cervex-Brush®. One month later, self-collected (SC) material was acquired using a Rovers® Viba-Brush. Liquid-based cytology specimens were prepared from both samples, and then the grades of squamous intraepithelial lesions (SIL) were determined; following immunostaining with CINtec® PLUS, HPV status was analyzed using a linear array.
  
  
  RESULTS
  The mean double-positive cell scores (SCORE) in the CC samples were 3.2 in samples negative for intraepithelial lesions or malignancy, 1.3 in atypical squamous cells of undetermined significance, 87.1 in low-grade SIL, and 367 in high-grade SIL. According to HPV risk type, the mean SCORE was 16 in samples negative for HPV, 8.4 in low-risk HPV, 143 in high-risk HPV other than type 16, and 420 in HPV16 - with a statistical significance between high-risk HPV and type 16 (p < 0.05). The SCORE of the SC group was lower than that of the CC group because of the limited number of cells collected.
  
  
  CONCLUSIONS
  The SCORE showed a significant correlation with HPV16 compared with lesser-degree lesions. CINtec PLUS is useful as a diagnostic marker of progression of lesions and a surrogate marker of an elevated risk of high-grade lesions with HPV16.
authors: Department of Laboratory Sciences, Gunma University, Maebashi, Japan. toyosida@health.gunma-u.ac.jp
authors: Tomomi
authors: T
authors: Yoshida
authors: Takaaki
authors: T
authors: Sano
authors: Tatsuya
authors: T
authors: Kanuma
authors: Hiroshi
authors: H
authors: Inoue
authors: Teruko
authors: T
authors: Itoh
authors: Chiaki
authors: C
authors: Yazaki
authors: Mitsuo
authors: M
authors: Obara
authors: Toshio
authors: T
authors: Fukuda
mesh_terms: D000328:Adult; D000368:Aged; D014408:Biomarkers, Tumor / Q000378:metabolism*; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism*; D003581:Cytodiagnosis / Q000706:statistics & numerical data*; D003584:Cytological Techniques; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D006801:Humans; D007124:Immunoenzyme Techniques; D019394:Ki-67 Antigen / Q000378:metabolism*; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000150:complications*; D016133:Polymerase Chain Reaction; D011379:Prognosis; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000821:virology
chemical_list: D014408:Biomarkers, Tumor; D019941:Cyclin-Dependent Kinase Inhibitor p16; D004279:DNA, Viral; D019394:Ki-67 Antigen