Efficiency of the hybrid capture 2 HPV DNA test in cervical cancer screening. A study by the French Society of Clinical Cytology

Am J Clin Pathol. 2003 Oct;120(4):492-9. doi: 10.1309/XFUC-PP6M-5XUA-94B8.

Abstract

The aim of this study was to determine the efficiency of the Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) human papillomavirus (HPV) assay for the detection of cervical neoplasia. Of the 1,785 patients recruited, 462 (25.88%) were referred for colposcopy owing to previously detected cytologic abnormalities, and 1,323 (74.12%) were voluntary candidates for screening. For all patients, a Papanicolaou smear and a monolayer smear (ThinPrep, Cytyc, Boxborough, MA) were done. HPV DNA was detected on the residual liquid-based material. False-positive results were observed in 111 cases and comprised 34 cross-reactions (1.90%) and 77 false-positive cases (4.31%) owing to a contiguous strong chemiluminescence signal. Interestingly, all these samples had a relative light units value of 1 to 3 and were contiguous to a sample with a very high HPV DNA load. The final results showed that high-risk and low-risk HPV DNA were detected in 480 samples (26.89%) and 135 samples (7.56%), respectively. Although HC2 can be considered a reliable and sensitive test for HPV DNA detection, we do not advocate its use for large-scale screening for cervical neoplasia.

Publication types

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

MeSH terms

  • Adult
  • Aged
  • DNA, Viral / analysis*
  • Diagnostic Errors
  • Female
  • France
  • Humans
  • Mass Screening / economics
  • Mass Screening / methods*
  • Middle Aged
  • Nucleic Acid Hybridization
  • Papanicolaou Test*
  • Papillomaviridae / genetics
  • Papillomaviridae / isolation & purification*
  • Papillomavirus Infections / diagnosis*
  • Prospective Studies
  • Sensitivity and Specificity
  • Societies, Scientific
  • Tumor Virus Infections / diagnosis*
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / prevention & control
  • Vaginal Smears*

Substances

  • DNA, Viral