HPV testing (by genetic analysis) of cervical smears is known to be more sensitive than conventional cytology for detecting pre-malignant cervical cells called high-grade cervical intraepithelial neoplasia (CIN2/CIN3); however HPV testing is less specific than cytology (ie. it produces more 'false-positive' results). HPV testing as a primary screening approach is only feasible if appropriate management is given to women who are HPV-positive with negative or borderline cytology results.

The HART (HPV in Addition to Routine Testing) study was led by Jack Cuzick and colleagues from Cancer Research UK. Around 11,000 women aged 30-60 years from 161 GP practices in 5 UK regions participated in the study between 1998 and 2001. Women with borderline cytology and women positive for high-risk HPV with negative cytology were randomised to immediate colposcopy (detailed examination of the cervix) or to surveillance by repeat HPV testing, cytology, and colposcopy at 12 months.

HPV testing was more sensitive than borderline or worse cytology (97% compared with 77%) but slightly less specific (93% compared with 96%) for detecting malignant cells. Surveillance at 12 months was as effective as immediate colposcopy for women with minimal abnormalities, i.e., those women with either borderline cytology results (regardless of HPV status) or who were HPV positive but had negative cytology results.

Jack Cuzick comments: "HPV testing could be used for primary screening in women older than 30 years, with cytology used to triage HPV-positive women. HPV-positive women with normal or borderline cytology (about 6% of screened women) could be managed by repeat testing after 12 mon
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Contact: Joe Santangelo
j.santangelo@elsevier.com
212-633-3810
Lancet
4-Dec-2003