A parallel study of careHPV and Hybrid Capture 2 human papillomavirus DNA testing for cervical cancer screening in rural China.

Hybrid Capture 2 (HC2) has been demonstrated to be a feasible screening method for cervical cancer. Based upon HC2 technology, careHPV is a simple, rapid, accurate, and inexpensive screening test for women in low-resource settings. This study aims to characterize both the careHPV test and HC2 test, and to compare careHPV results of specimens stored in careHPV test collection medium (TCM) to HC2 results from partner specimens stored in Qiagen specimen transport medium and TCM. The positive rates of high-risk HPV in careHPV, HC2, and HC2 (TCM) were 13.2% (108/818), 13.2% (108/818), and 13.6% (111/818), respectively. The agreement rates of pairwise tests were 95.8% (95% CI: 94.5-97.2%), 96.7% (95% CI: 95.5-97.9%), and 97.2% (95% CI: 96.1-98.3%), respectively. The Kappa values of the pairwise tests were 0.82 (95% CI: 0.76-0.88), 0.86 (95% CI: 0.81-0.91), and 0.88 (95% CI: 0.83-0.93), respectively. Based on these findings, although careHPV is demonstrated to be a viable alternative to the HC2 test, improvements on the careHPV test are still required prior to its implementation as a suitable screening method for women in low-resource settings. Further studies on the significance and applicability of the careHPV test must be performed.