Evaluation of Self-Sampling-Based Cervical Cancer Screening Strategy During COVID-19 Pandemic

Background

Primary human papillomaviruses (HPV) cervical cancer screening can be strengthened by offering home-collection of biological specimen as a valuable option to increase screening coverage. The World Health Organization (WHO) recommends considering the inclusion of HPV self-sampling within existing screening algorithms to address gaps in current coverage. This study aimed to test a self-sampling-based screening strategy in Trieste, Italy, during the COVID-19 pandemic to reduce screening delays caused by lockdowns.

Methods

500 women, who should have received the screening call in 2020, were asked to participate in the study. Those who agreed were sent a home-collection kit, including a vaginal dry swab for specimen collection. The recipients performed the sample self-collection and sent back the swab through traditional mail. The samples were analyzed with HPV Selfy, a CE-IVD HPV screening test validated for self-collection.

Results

80% of women sent back their swab, showing one of the highest return rates in comparable studies. 34 HPV-positive women were followed up, revealing 8 low squamous intraepithelial lesions (LSIL) cases. HPV Selfy was confirmed to be an adequate test for self-sampling-based screening.

Conclusions

The study confirmed the feasibility of a self-test at home screening strategy based on self-sampling with an opt-in system as a support method to enhance cervical cancer screening coverage in Italy. Enrolled women showed high appreciation for this approach, and the HPV Selfy test demonstrated to be a valuable assay for cervical cancer screening based on home self-collection.

Cervical cancer is the fourth most common female cancer worldwide, with more than 90% of cases found in low-income countries due to the lack of cervical screening programs. The validation of HPV molecular tests on self-collected samples offers the opportunity to increase cervical cancer screening coverage, aiming to reach a global target of 70% screening coverage by 2030.

This study further encourages the effectiveness and feasibility of a 'self-collection at home' based cervical cancer screening program, highlighting the importance of using tests clinically validated for self-collected samples to ensure accurate and reliable screening results.