Abstract
New, lower-cost tests that target high-risk human papillomavirus (HR-HPV) have been developed for cervical cancer screening in lower-resource settings but large, population-based screening studies are lacking. Women ages 25 to 65 years and living in rural China (n = 7,543) self-collected a cervicovaginal specimen, had 2 cervical specimens collected by a clinician, and underwent visual inspection after acetic acid (VIA). The self- and one clinician-collected specimens underwent HR-HPV DNA testing by careHPV (QIAGEN) and Hybrid Capture 2 (HC2; QIAGEN) and the other clinician-collected specimen was tested for HPV16, 18, and 45 E6 using OncoE6 (Arbor Vita Corporation). Women who screened positive for any test and a random sample of those negative on all tests underwent colposcopic evaluation. The percent test positive was 1.8% for HPV E6 oncoprotein, between 14% and 18% for HR-HPV DNA testing, and 7.3% for VIA. The sensitivity for cervical intraepithelial neoplasia grade 3 or more severe (CIN3(+); n = 99) was 53.5% for OncoE6, 97.0% for both careHPV and HC2 testing of the clinician-collected specimen, 83.8% for careHPV testing and 90.9% for HC2 testing of the self-collected specimen, and 50.5% for VIA. OncoE6 had the greatest positive predictive value (PPV), at 40.8% for CIN3(+), compared with the other tests, which had a PPV of less than 10%. OncoE6 tested 70.3% positive for HPV16, 18, or 45-positive CIN3(+) and tested negative for all HPV16-, 18-, or 45-negative CIN3(+) (P < 0.0001). HPV E6 oncoprotein detection is useful for identifying women who have cervical precancer and cancer.
Highlights
The unequal burden of cervical cancer in resource-limited populations stems primarily from well-known limitations of Pap testing [1]
Clinical management Women who tested positive for any of the 6 screening tests conducted (VIA, HPV AVantage HPV E6 test for HPV16 (E6), and Hybrid Capture 2 (HC2) and careHPV on clinician-collected and self-collected specimens) were referred to colposcopy, and approximately 10% random sample of the women who tested negative for all screening tests underwent a rigorous colposcopic evaluation that included using a biopsy protocol as previously described [16]
Because of the restrictions in taking biopsies from women who were negative on all 6 screening tests, of the 485 screen-negative women who went to colposcopy, only 22 (4.5%) were biopsied and none had CIN2þ [0.0%; 95% confidence interval (CI), 0.0–15.4]
Summary
The unequal burden of cervical cancer in resource-limited populations stems primarily from well-known limitations of Pap testing [1]. The development and validation of novel, low-cost, and robust screening strategies are much needed if the unequal burden of cervical cancer worldwide is to be addressed. To address the first limitation and increase access to screening, lower-cost tests have been developed and are undergoing validation studies. The first of these is careHPV (QIAGEN), a signal amplification DNA test for a pool of 14 HR-HPV genotypes. Larger-scale evaluations of both lower-cost tests and strategies on how to use them are currently lacking To address this gap, we conducted a clinical trial in 7,500 women living in rural China. The goal of this first report from this cohort is to characterize the screening performance (sensitivity, specificity, and predictive values) of multiple screening options using these lower-cost tests, including the first trial of the OncoE6 test
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