PCR-based high-risk HPV test in cervical cancer screening gives objective risk assessment of women with cytomorphologically normal cervical smears

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Abstract
Cervical‐cancer screening programmes using cytomorphological criteria could be more efficient if the screening included objective individual risk factors for women with normal cytology, such as a test for high‐risk human papillomavirus (HPV). The value of a PCR‐based test for high‐risk HPV types was studied in a cohort of 1622 women presenting in a routine biannual population‐based screening programme. Women were included in the study when they had no previous history of cervical dysplasia; and their initial Pap smear was read as normal (Pap 1 or 2). The mean age of the women was 42 years (range 34–54 years) and mean follow‐up time was 40 months (range 5–73 months). Women were referred for colposcopically directed biopsies if they had had 2 successive cervical smears read as Pap 3a (mild to moderate dyskaryosis) or one read as ≄ Pap 3b (severe dyskaryosis). Women with histologically confirmed cervical intraepithelial neoplasia grade III (CIN III) were considered positive cases. All women were tested for 14 high‐risk HPV genotypes. Of the 86 high‐risk HPV‐positive women, 6 developed CIN III, whereas only 1 of the 1536 HPV‐negative women did. The women with normal Pap smears containing high‐risk HPV genotypes were 116 times (95% Cl, 13–990) more at risk of developing CIN III, in contrast to women without high‐risk HPV. These results support the view that the interval between successive smears in cervical‐cancer screening can be increased considerably for women with cytomorphologically normal and high‐risk HPV‐negative cervical smears as determined by PCR. © 1996 Wiley‐Liss, Inc.