Evaluation of the Clinical Performance of High-Risk Human Papillomavirus Testing for Primary Screening: A Retrospective Review of the Southern California Permanente Medical Group Experience

Objective. We investigated the potential impact of using the high-risk human papillomavirus (HPV) test as a primary screening tool for the detection of cervical cancer and its precursor lesions. Materials and Methods. From October 2005 to March 2006, conventional cervical cytological samples and Hybrid Capture II HPV tests were cocollected from all patients. Human papillomavirus tests were processed in all women aged 30 years and older and women younger than 30 years with a cytological finding of atypical squamous cells of undetermined significance. Patients with biopsyproven cervical intraepithelial neoplasia (CIN) served as the study population. Results. We identified 263 women with CIN of whom 194 (73.8%) (95% confidence interval [CI] = 68.2%-78.8%) had HPV results. Human papillomavirus tests were negative in 4 (6.1%) of 66 CIN 3 cases (95% CI = 2.1%-14.5%), in 8 (16%) of 50 CIN 2 cases (95% CI = 7.3%-28.2%), and in 22 (22.8%) of 78 CIN 1 cases (95% CI = 18.6%-38.9%) distributed across all referral cytology categories. Negative HPV test rates were most significant for CIN 1 cases anteceded by a cytological finding of atypical squamous cells of undetermined significance (p = .0016). The mean age of women with HPV-negative CIN was 10 years older than that for women with HPV-positive CIN. Conclusions. Human papillomavirus testing may miss more CIN than previously reported, especially in older women. Prospective trials of HPV testing as a primary screen for cervical cancer should incorporate additional tests to minimize missed lesions.