High-risk HPV nucleic acid detection kit-the careHPV test -a new detection method for screening

Sci Rep. 2014 Apr 16;4:4704. doi: 10.1038/srep04704.

Abstract

This study assessed the clinical accuracy of the correlation between the careHPV test and the HC2 test, as well as the correlation between the careHPV test and the HPV-PCR test. From September 21 to December 31, 2009, 419 cervical specimens from women, 30-49 years, were collected. All women were assessed by Digene HC2 High-Risk HPV DNA Test (HC2), careHPV test, and HPV-PCR. The concordance rate between careHPV and HC2 was 93.81% and between careHPV and HPV-PCR 88.12%. The sensitivity and specificity of the careHPV test to detect cancers of equal or greater severity than CIN 2 were 85.71% and 83.15% respectively. Results from careHPV, HC2, and HPV-PCR were highly consistent. The careHPV test has good sensitivity and specificity for the detection of HPV infection and is a promising primary screening method for cervical cancer in low-resource regions.

Publication types

  • Evaluation Study

MeSH terms

  • Adult
  • Area Under Curve
  • Cervix Uteri / virology*
  • DNA, Viral / analysis*
  • Female
  • Humans
  • Middle Aged
  • Papillomaviridae / genetics*
  • Papillomaviridae / isolation & purification
  • Polymerase Chain Reaction*
  • ROC Curve
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Uterine Cervical Neoplasms / diagnosis
  • Uterine Cervical Neoplasms / virology

Substances

  • DNA, Viral
  • Reagent Kits, Diagnostic