Human Papillomavirus DNA Testing for Cervical Cancer Screening in Low-Resource Settings

In many low-resource settings there are barriers to cytologic screening for cervical cancer. This study evaluates human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing as an alternative screening method. Cervical samples from 2944 previously unscreened South African women aged 35-65 years were tested for high-risk types of HPV with the use of Hybrid Capture I (HCI) assay. Women also had a Pap smear direct visual inspection of the cervix and Cervicography. Women positive on any screening test were referred for colposcopy. Samples from women with biopsy-confirmed low-grade squamous intraepithelial lesions (SILs) (n = 95) high-grade SILs (n = 74) or invasive cervical cancer (n = 12) and a random sample of women with no cervical disease (n = 243) were retested for HPV DNA with the use of the more sensitive Hybrid Capture II (HCII) assay. All P values are two-sided. Results show that high-risk HPV DNA was detected in 73.3% and 88.4% of 86 women with high-grade SIL or invasive cancer and in 12.2% of 2680 and 18.1% of 243 women without evidence of cervical disease with the use of the HCI and HCII assays respectively. HPV DNA testing with the HCII assay was more sensitive than cytology for detecting high-grade SIL and invasive cancer (McNemars test P = 0.04) and testing with the HCI assay was of equivalent sensitivity (P = 0.61). Cytology had a statistically significantly better specificity (96.8%) than either the HCI assay (87.8%) or the HCII assay (81.9%) (P < 0.01). Receiver operating characteristics curves identified test cut-off values that allow HPV DNA testing to identify 57% of women with high-grade SIL or cancer while classifying less than 5% of women with no cervical disease as HPV DNA positive. In conclusion HPV DNA testing has a sensitivity equivalent to or better than that of cytology. Since HPV DNA testing programs may be easier to implement than cytologic screening HPV testing should be considered for primary cervical cancer screening in low-resource settings. (authors)