Shaokai Zhang

HPV testing with 16/18 genotyping for risk stratification among women with normal cytology: a multicenter prospective cohort study from China

ABSTRACT To evaluate the clinical performance of Hybribio’s 14-type HPV real-time PCR with 16/18 genotyping (HBRT-H14) and its risk stratification utility among women with normal cytology (NILM). From 2017 to 2020, a multicenter cohort enrolled 8,401 women aged 30–64 years with NILM cytology. Baseline HPV testing used HBRT-H14. Women positive for HPV 16/18 were referred for colposcopy; follow-up was annual for 3 years or until the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Analyses included 6,679 women who completed follow-up. Overall HPV positivity was 11.4%, including 2.3% HPV 16/18. Over 3 years, sensitivity and specificity of HPV positivity for CIN2+ were 92.3% (95% confidence interval [CI]: 84.2–96.4) and 89.6% (88.8–90.3). For HPV 16/18 positivity, sensitivity and specificity were 41.0% (30.8–52.1) and 98.2% (97.8–98.5). Three-year cumulative CIN2+ risk was 20.9% (15.2–28.1) for HPV 16/18-positive women, 6.6% (4.9–8.9) for other types, and 0.1% (0.04–0.2) for HPV-negative women. HBRT-H14 shows strong clinical performance for detecting CIN2+, and HPV 16/18 genotyping provides effective risk stratification among women with NILM cytology. Findings support integration of HBRT-H14 into HPV-based screening pathways with HPV 16/18 genotyping and cytology triage of other types. IMPORTANCE This multicenter prospective study evaluated the Hybribio 14 high-risk HPV real-time PCR assay (HBRT-H14) in 8,401 women with normal (NILM) cytology under guideline-based follow-up. The assay showed high clinical sensitivity and a very low risk among HPV-negative women, and HPV 16/18 genotyping provided clear risk stratification. These findings deliver large-scale, practice-oriented evidence supporting integration of HBRT-H14 into HPV-based screening pathways that use HPV 16/18 genotyping with cytology triage of other types.

Age-specific clinical performance of HPV-based vs. cytology-based cervical cancer screening in China

Cervical cancer remains a significant health burden, and effective screening is essential, yet the age-specific performance of HPV primary screening is rarely studied. This multicenter study evaluates age-specific performance of primary human papillomavirus (HPV) testing as cross-sectional and longitudinal screening for cervical cancer among 28,501 Chinese women. At baseline, HPV screening with cytology triage demonstrates higher sensitivity (96.9% vs. 79.7%) but slightly lower specificity (88.8% vs. 92.7%) than cytology with HPV triage for cervical intraepithelial neoplasia grade 2 or worse (CIN2+). HPV sensitivities remain high across age groups (≤35: 100.0%; 36-45: 96.4%; >45: 96.8%), consistently exceeding the corresponding cytology sensitivities (66.7%, 75.7%, and 84.9%). Over a three-year follow-up, HPV screening maintains superior sensitivity (93.1% vs. 58.1%) and slightly lower specificity (89.6% vs. 92.4%) compared with cytology. Age-stratified analyses in the longitudinal setting reveal trends similar to those observed in the cross-sectional analyses. Women positive for HPV16/18 have a 43.0% three-year risk of CIN2+, compared with 0.2% for HPV-negative women. These findings support the durable protection of HPV-based screening and the feasibility of extending screening intervals.

Comparison of primary cytology, primary HPV testing and co-testing as cervical cancer screening for Chinese women: a population-based screening cohort

Objectives We compared clinical performance of three strategies of primary human papillomavirus (HPV) testing, primary cytology and co-testing for cervical cancer screening. Design A population-based prospective cohort study of clinical performance of screening strategy. Setting Patients recruited from community in Changzhi County, Shanxi Province, China. Patient 3209 women aged 30–64 years without gynaecological issues. Primary and secondary outcome measures The performance of different screening strategies for detecting cervical intraepithelial neoplasia grade 2 or more severe (CIN2+). Results A total of 53 CIN2+ and 31 CIN3+ cases are detected. For CIN2+, sensitivity of primary HPV (95.9%) and co-testing (98.0%) are not statistically different, but significantly higher than primary cytology (48.0%). Specificity (86.8%), colposcopy referral rate (7.8%) and number of colposcopies required to detect one case (9.8) for primary HPV are better than co-testing (79.8%, 11.9%, 14.3%, respectively). For CIN3+, primary HPV, co-testing have 100% of sensitivity and specificity, which is significantly higher than primary cytology (56.7% and 90.2%). Number of colposcopies required to detect one case for primary HPV (15.9) is better than co-testing (23.8). Conclusions Compared with co-testing, HPV primary screening had comparable sensitivity and higher specificity for CIN2+ detection, and both of them showed better performance than cytology primary screening in cervical cancer screening.

An Internet-Based Education Program for Human Papillomavirus Vaccination Among Female College Students in Mainland China: Application of the Information-Motivation-Behavioral Skills Model in a Cluster Randomized Trial

Background Patients diagnosed with cervical cancer in the last 2 decades were mainly young females. Human papillomavirus (HPV) vaccination is the most radical way to prevent HPV infection and cervical cancer. However, most female college students in mainland China have not yet been vaccinated, and their relevant knowledge is limited. Theory-based education delivered via the internet is a potentially accessible and useful way to promote HPV vaccination among this population. Objective This 3-month follow-up study intended to identify the feasibility and efficacy of an information-motivation-behavioral skills (IMB) model–based online intervention for promoting awareness and willingness regarding HPV vaccination among female college students. Methods A 7-day online HPV education program for female college students in mainland China was developed using a cluster randomized trial design. Recruitment and questionnaire surveys were performed online without face-to-face contact. SPSS 23.0 was used for statistical analysis. The chi-square test and t test were used to compare differences in qualitative and continuous variables between intervention and control groups. The generalized estimating equation was used to test the effectiveness of the intervention with a consideration of the time factor. Results Among 3867 participants, 102 had been vaccinated against HPV before the study (vaccination rate of 2.6%). A total of 3484 participants were followed up after the baseline survey, with no statistical difference in the loss rate between the intervention and control groups during the intervention and follow-up periods. At different follow-up time points, HPV-related knowledge, and the motivation, behavioral skills, and willingness regarding HPV vaccination were higher in the intervention group than in the control group. HPV-related knowledge was statistically different between the 2 groups, while the motivation, behavioral skills, and willingness regarding HPV vaccination only showed statistical differences right after the intervention, reaching a peak right after the intervention and then gradually reducing over time. Furthermore, there was no statistical difference in the HPV vaccination rate between the 2 groups. Conclusions IMB model–based online education could be a promising way to increase the HPV vaccination rate and reduce the burden of HPV infection and cervical cancer among high-risk female college students in China. Trial Registration Chinese Clinical Trial Registry ChiCTR1900025476; http://www.chictr.org.cn/showprojen.aspx? proj=42672 International Registered Report Identifier (IRRID) RR2-DOI:10.1186/s12889-019-7903-x