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Efficiency of the Hybrid Capture 2 HPV DNA Test in Cervical Cancer Screening
A Study by the French Society of Clinical Cytology

Patricia de Cremoux MD, PhD, Joël Coste MD, PhD, Xavier Sastre-Garau MD, PhD, Martine Thioux, Christelle Bouillac, Sylvain Labbé MD, Isabelle Cartier MD, Marianne Ziol MD, Anne Dosda MD, Catherine Le Galès PhD, Vincent Molinié MD, Marie-Cécile Vacher-Lavenu MD, PhD, Béatrix Cochand-Priollet MD, PhD, Philippe Vielh MD, PhD, Henri Magdelénat PhD
DOI: http://dx.doi.org/10.1309/XFUCPP6M5XUA94B8 492-499 First published online: 1 October 2003

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.

Key Words:
  • Cervical cancer
  • Screening
  • Human papillomavirus
  • Hybrid Capture 2 test