title: Role of p16/INK4a and Ki-67 as specific biomarkers for cervical intraepithelial neoplasia: An institutional study.
abstract: BACKGROUND
  P16/INK4a and Ki-67 have emerged as important biomarkers for the detection of high-risk human papilloma virus (HR-HPV) associated dysplastic changes in the cervical biopsy samples. The increasing inter- and intra-observer variability in the diagnosis of dysplastic lesions and immature squamous metaplasia on histopathology has led to the advent of these biomarkers. This study was taken up with an aim to study their role in increasing the diagnostic accuracy in equivocal cases on histopathology.
  
  
  METHODS
  Fifty cervical biopsy specimens were stained with p16/INK4a and Ki-67 consisting of 10 cases each of cervical intraepithelial neoplasia (CIN I/II/III) along with five cases of squamous metaplasia. Histopathological diagnosis was considered as the gold standard. Statistical analysis was done by kappa statistics, andPvalue was calculated.
  
  
  RESULTS
  The sensitivity and specificity of p16/INK4a and Ki-67 were 76.2%, 87.5%, 90.5%, and 87.5%, respectively. The overall agreement of both the immunostains with histopathological diagnosis was statistically significant (P< 0.05) and the diagnostic accuracy improved when both the stains were used in conjunction.
  
  
  CONCLUSIONS
  Ki-67 and p16/INK4a can be used as complimentary tests in differentiating dysplastic and nondysplastic lesions and help in confirming the histopathological diagnosis. They aid in recognition of dysplasias caused by HR-HPV, which have higher tendency to progress to neoplasia. However, further research is advocated before the widespread use of these markers for screening of dysplasias.
authors.affiliation: Department of Pathology, ESIC MC and PGIMSR, Rajajinagar, Bengaluru, Karnataka, India.
authors.forename: Ankitha
authors.initials: A
authors.lastname: Hebbar
authors.affiliation: Department of Pathology, ESIC MC and PGIMSR, Rajajinagar, Bengaluru, Karnataka, India.
authors.forename: Venkataramappa Srinivasa
authors.initials: VS
authors.lastname: Murthy
keywords: Cervical intraepithelial neoplasia; Ki-67; human papilloma virus; p16/INK4a