Evaluation of the SureX HPV genotyping test for the detection of high-risk HPV in cervical cancer screening
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RESEARCH
Evaluation of the SureX HPV genotyping test for the detection of high‑risk HPV in cervical cancer screening Baojun Wei1, Ping Mei2, Shengkai Huang1, Xueting Yu1, Tong Zhi3, Guojing Wang1, Xiaotian Xu1, Lin Xiao1, Xin Dong1 and Wei Cui1*
Abstract Background: The SureX HPV genotyping test (SureX HPV test), which targets the human papillomavirus (HPV) E6/ E7 genes was compared with the Cobas 4800 and Venus HPV tests for detecting 14 high-risk HPV (HR-HPV) types in clinical referral and follow-up patients to evaluate its value for cervical cancer screening. Methods: Two different populations were enrolled in the study. The first population comprised 185 cases and was used for comparing the SureX HPV test (Health, China) with the Cobas 4800 test (Roche, USA). The second population comprised 290 cases and was used for comparing the SureX HPV test (Health, China) with the Venus HPV test (Zhijiang, China). Polymerase chain reaction (PCR) sequencing was performed for further confirmation of discordant results. Results: In the first population, the overall agreement rate was 95.6% for 14 high-risk HPV types. Eight discordant cases were confirmed by PCR sequencing, which showed that the agreement rates were 75.0% between the SureX HPV test and PCR sequencing and 25.0% between the Cobas 4800 test and PCR sequencing (P 0.05). Conclusion: The SureX HPV test had good consistency with both the Cobas 4800 and Venus HPV tests for 14 HR-HPV types. In addition, it avoided some false negatives and false positives. Therefore, the SureX HPV test can be used for cervical cancer screening. Keywords: High-risk human papillomavirus, HPV DNA test, Cervical cancer screening
*Correspondence: [email protected] 1 Department of Clinical Laboratory, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17 Panjiayuannanli, Beijing 100021, People’s Republic of China Full list of author information is available at the end of the article
Background Cervical cancer is one of the most common malignant tumors of the reproductive system in women. There were approximately 570,000 new cases of cervical cancer and 311,000 deaths worldwide in 2018 [1]. Persistent infection with high-risk human papillomavirus (HR-HPV) is recognized as the main cause of cervical cancer and precancerous lesions [2, 3]. HR-HPV DNA test for cervical specimens has been demonstrated as an effective
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