Vijayalakshmi Ramshankar

Impact of HPV molecular testing with partial genotyping as a feasibility study in cervical cancer community screening program in South India

AbstractCervical cancer can be eradicated by 2030 by the implementation of a global strategy involving the vaccination of young girls against human papillomavirus (HPV), screening 70% of women in 30–69 years of age and treating 90% of the women with precancerous lesions. For a country with a large population like India, all the three strategies can be a challenge. There is a need for implementation of a high throughput technology that can be scalable. Cobas 4800, a multiplexed assay based on quantitative polymerase chain reaction technology, identifies HPV 16 and HPV 18 along with the concurrent detection of 12 pooled other high‐risk HPV infections. This technology was used to test 10 375 women from the South Indian community for the first time as a feasibility program. Upon testing, high‐risk HPV was found in 595 (5.73%) women. A total of 127 women (1.2%) were found to be infected with HPV 16, 36 women (0.34%) with HPV 18 and 382 women (3.68%) with the 12 pooled high‐risk HPV and multiple mixed infections were found in 50 women (0.48%). It was observed that there was a high prevalence of high‐risk HPV in younger women, 30–40 years of age and a second peak was observed at 46–50 years of age. The second peak had higher mixed infections in the 46–50 years of age and this association was statistically significant. We found that 24/50 (48%) of the multiple mixed high‐risk HPV infections were in the age group 46–50 years. The current study is the first attempt from India, on a completely automated platform using Cobas 4800 HPV test in a community screening program. This study shows HPV 16 and HPV 18 infections, when differentiated, can be valuable for risk stratification in community screening program. Women in the perimenopausal age (46‐50yrs) showed a higher prevalence of multiple mixed infections, signifying a higher risk.

Performance of HPV Self-Sample Collected by a Novel Kit in Comparison with Clinician Collected Sample for Cervical Cancer Screening

We are reporting the performance of HPV self-sample collected by a novel kit in comparison with clinician collected cervical sample for HPV testing for cervical cancer screening. Consenting, eligible women aged 25 to 60, with a positive cervical cancer screening test report in the past one year but without any prior treatment for cervical abnormalities were enrolled in the study. Each woman provided 2 samples for the HPV test (vaginal self-sample collected with the CERVICHECKTM, an indigenous kit from India and cervical sample collected by the clinician). These samples were analysed using cobas HPV test on 4800 platform and for liquid-based cytology. We enrolled 156 eligible, consenting participants at 2 study sites. The agreement for the sample collected by CERVICHECKTM and clinician collected sample for any high-risk HPV was 95.1% (k= 0.90, SE 0.036, 95% CI 0.83-0.97). The agreement for HPV 16 or 18 only was 95.1%, (k=0.88, SE 0.045, 95% CI 0.79-0.97). The overall acceptability of the kit was good, participants expressed that self-sampling was easy and > 90% women were willing to recommend it to their friends. There was almost perfect or perfect agreement between the HPV self-sample collected by CERVICHECKTM and clinician collected cervical sample. Self-sampling was highly acceptable to the participating women.