August 2nd, 2021

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Comparison of CerviHPV and Cobas 4800 HPV Tests for Detection of High-Risk HPV Infection in Cervical Swab Specimens
Authors:  Yingying Du, B.S. Guodong Zhao, M.S., Zhaocheng Liu, B.S., Jinli Sun, B.S., Hui Wang, B.S., Minxue Zheng, Ph.D., and Yong Ma, Ph.D.
  OBJECTIVE: To evaluate the performance of a new high-risk human papillomavirus (HR-HPV) detection assay, CerviHPV High-Risk HPV Test (CerviHPV), by comparison to the cobas 4800 HPV Test (cobasHPV).

STUDY DESIGN: A collection of 437 cervical swab specimens of different cobasHPV results were retested with CerviHPV for comparison. Both tests employ multiplex real-time quantitative PCR to detect 14 HR-HPV types simultaneously in a single reaction along with a cellular control to avoid false negative results. They can genotype the two most carcinogenic types, HPV16 and 18, while detecting any of the other 12 HR-HPV types (12HPV for abbreviation) as a pool. Both tests were also used to analyze a set of simulation samples with known compositions for further differentiation.

RESULTS: The concordance rates between the two tests were 99.5%, 100%, 91.7%, and 92.2%, respectively, for HPV16, HPV18, 12HPV, and all 14 HR-HPV types, and the corresponding kappa values were 0.987, 1.000, 0.782, and 0.839, demonstrating highly comparable performance qualitatively. This was further buttressed by correlation analysis between the two sets of test results that showed quantitative comparability. In the simulation experiment, CerviHPV detected the 12HPV types more uniformly than did cobasHPV.
CONCLUSION: Our results indicated that CerviHPV has the potential to become another high-quality HR-HPV test for cervical cancer screening and prevention in clinics.
Keywords:  cervical cancer; cervical disease; cervical intraepithelial neoplasia; CerviHPV test; Cobas 4800 HPV test; colposcopy; HPV; HPV DNA tests; human papillomavirus; human papillomavirus DNA tests; human papillomavirus 16; human papillomavirus 18; multiplex PCR; multiplex polymerase chain reaction; multiplex quantitative PCR
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