Primary screening with HPV DNA testing feasible in some women

Cervical screening using primary HPV DNA-based screening with cytology triage and repeat HPV DNA testing may be the most appropriate approach for cytology-negative women, according to data from a recent analysis.

Researchers examined data from Swedescreen — a population-based, randomized trial of double screening with cytology and HPV DNA testing — to determine the efficacy of HPV DNA testing as the primary screening test among women with positive cytology and positive HPV DNA.

Using the intervention arm of the study (n=6,257), the researchers examined the efficacy of 11 cervical screening strategies based on HPV DNA testing alone, cytology alone and HPV DNA testing plus cytology among women aged 32 to 38 years. The primary outcome measures were sensitivity for detection of CIN3+ cervical intraepithelial neoplasia within six months of enrollment or at colposcopy for women with a persistent type-specific HPV infection, and the number of screening tests and positive predictive value for each strategy, according to the researchers.

Double testing with cytology and for type-specific HPV yielded a 35% increase in sensitivity to detect CIN3+ and did not significantly reduce positive predictive value (PPV=0.76; 95% CI, 0.52-1.10). Double testing, however, resulted in the need for more than twice as many screening tests (105% more than cytology alone).

Compared with cytology, other screening methods that incorporated screening for high-risk HPV subtypes resulted in a reduction of positive predictive value.

Primary screening with HPV DNA followed by cytological triage and repeat HPV DNA testing of HPV DNA-positive women with normal cytology resulted in a 30% increase in the sensitivity to detect CIN3+ (95% CI, 9%-54%) while maintaining a high positive predictive value (PPV=0.87; 95% CI, 0.60-1.26). Screening using this method resulted in a 12% increase in the number of screening tests needed from 6,257 to 7,019.

J Natl Cancer Inst. 2009;101:88-99.