Analytical performance of Cervista HPV 16/18 genotyping test for cervical cytology samples

J Clin Virol. 2011 May;51(1):38-43. doi: 10.1016/j.jcv.2011.01.016. Epub 2011 Mar 4.

Abstract

Background: Human papillomavirus (HPV) types 16 and 18 are the 2 most frequent types associated with cervical cancer. Identifying their presence or absence in cervical samples may assist in triaging women for subsequent management. The Cervista HPV 16/18 genotyping test specifically detects the presence of HPV 16 and 18 in ThinPrep cervical specimens.

Objectives: The objective was to establish the analytical performance of the CERVISTA HPV 16/18 genotyping test.

Study design: These studies were performed in support of a regulatory submission to the US Food and Drug Administration. Here we report the analytical sensitivity (limit of detection), accuracy compared to consensus L1 gene PCR/bi-directional sequencing, precision, reproducibility, and cross-reactivity (specificity) of the genotyping test.

Results: Analytical sensitivity for detection of HPV 16 and 18 ranged between 625 and 1250 copies/reaction for both types. When compared to PCR/sequencing for women with atypical squamous cells of undetermined significance cytology, the positive percent agreement was 94.1% (95% confidence interval [CI], 89.8-96.7) and the negative percent agreement was 85.7% (95% CI, 82.4-88.4). The test demonstrated high within-laboratory and inter-operator precision. Reproducibility within sites and between 3 testing sites resulted in 100% agreement with expected results (150 positive, 90 negative results). The genotyping test did not exhibit cross-reactivity to DNA from common low-risk HPV types and other microorganisms found in the human female reproductive tract.

Conclusions: These analytical performance data support the use of CERVISTA HPV 16/18 genotyping test for the detection and differentiation of HPV 16 and 18 in ThinPrep cervical cytology specimens.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Cervical Intraepithelial Neoplasia / genetics
  • Cervical Intraepithelial Neoplasia / virology*
  • Cervix Uteri / virology*
  • Cross Reactions
  • DNA, Viral / genetics
  • DNA, Viral / isolation & purification
  • Female
  • Genotype
  • Human papillomavirus 16 / genetics
  • Human papillomavirus 16 / isolation & purification*
  • Human papillomavirus 18 / genetics
  • Human papillomavirus 18 / isolation & purification*
  • Humans
  • Molecular Typing
  • Papillomavirus Infections / genetics
  • Papillomavirus Infections / virology*
  • Polymerase Chain Reaction
  • Pregnancy
  • Pregnancy Complications / genetics
  • Prospective Studies
  • Reproducibility of Results
  • Sensitivity and Specificity
  • United States
  • Uterine Cervical Neoplasms / genetics
  • Uterine Cervical Neoplasms / virology*
  • Vaginal Smears

Substances

  • DNA, Viral