Study Evaluates Cervical Cancer Screening with HPV 16 and 18 Genotyping

Studies have shown that a majority of cervical cancer incidences are due to infection with the human papillomavirus (HPV). There are 15 types of high-risk HPV that may lead to the development of cervical intraepithelial neoplasia (CIN) and cervical cancer. Although 15 types of HPV have been linked with cervical cancer, data showed that >50% of these cases are caused by HPV 16, and 10% to 15% are caused by HPV 18. Furthermore, HPV 18 causes >35% of cervical adenocarcinomas, which are hard to detect using cytological tests. See Table (below) for guidelines on screening. Researchers in this study evaluated the effectiveness of a real-time quantitative polymerase chain reaction method from Hybribio to detect 14 high-risk HPV with HPV 16 and HPV 18 genotyping kit (qPCR; HBRT-H14) for cervical cancer screening [Exp Ther Med. 2013;6(5):1332-1336].

The study included 424 females (age 20-55) who underwent cervical cancer screening and treatment at the China-Japan Friendship Hospital between August 15, 2011, and November 10, 2011. None of the participants exhibited acute inflammation of the reproductive tract. The participants were randomly divided into 2 groups (A and B) and underwent 2 different testing methods: the liquid-based cytology test (LCT) and a HPV DNA test. In group A, hybrid capture II and LCT were performed; in group B, 14 patients underwent high-risk HPV with HPV 16 and HPV 18 genotyping using the qPCR; HBRT-H14 test and LCT. Colposcopy testing and cervical biopsies were done in a cohort of 122 patients who were HBRT-H14 positive, diagnosed with atypical squamous cells-undetermined significance, or HPV 16 and/or HPV 18 positive in the HBRT-H14 assay but cytologically negative.

For the screening of CIN grade II or higher and cervical cancer, the sensitivity of HBRT-H14 HPV test was 96.3%, the specificity was 78.17%, the positive predictive value was 23.21%, and the negative predictive value was 99.68%. The results found statistically significant differences in the rates of cervical cancer and CIN II or higher among the HPV 16 positive, HPV positive 18, other high-risk HPV (excluding HPV 16 and 18) positive, and high-risk HPV negative patients. In group B, compared with other high-risk HPV types, HPV 16 and 18 infection led to greater possibility of cervical lesions graded CIN II or higher (8.11% and 51.28%, respectively).

To determine whether the HBRT-H14 test is only required in the cervical cancer screening of women ≥30 years of age, the participants were divided into 2 groups with 30 years of age as the borderline. The high-risk HPV infection rate was 21.76% (26/120) in women <30 years old (group 1) and 28.57% (86/301) in females ≥30 years (group 2), representing no statistical difference between the groups (P>.05). In HPV 16 positive participants in group 1 and group 2, the percentage of participants graded as CIN II or above was 25% and 65.38%, respectively; the difference was found to be statistically significant (P<.05).

“HBRT-H14 is applicable for cervical cancer screening with the advantage of genotyping for HPV 16 and HPV 18, which may help improve triage management for women with negative cytology,” concluded the researchers.