Cervical Cancer Screening Activity at an Accredited Centre in Romania, 2018-2025: COVID-19 Disruption, Recovery and the Transition to Primary HPV Testing.

BACKGROUND: Romania has one of the highest cervical cancer incidence and mortality rates in the European Union (EU) and one of the lowest levels of screening participation. We examined eight years of screening activity at an accredited centre in Bihor County, north-western Romania, encompassing the pre-pandemic period (2018-2019), the COVID-19 pandemic (2020-2021), the post-pandemic recovery (2022-2023) and the transition from primary cytology to primary human papillomavirus (HPV) DNA screening (2024-2025). METHODS: This retrospective, single-centre study included 17,807 de-identified screening-episode records collected between 2018 and 2025 at Pelican Clinical Hospital, Oradea. Cytology was the primary screening test in the cytology era (2018-2023), whereas high-risk HPV (HR-HPV) DNA testing (cobas HPV Test, Roche, Pleasanton, CA, USA) with reflex cytology was used in the HPV-primary era (2024-2025). Screening activity was expressed relative to the provider's registered administrative catchment of 65,978 women. Because quarterly counts were markedly overdispersed, changes in screening volume were analysed using negative-binomial incidence-rate ratios (IRRs) and a segmented negative-binomial interrupted time-series; cytological positivity was evaluated using age-adjusted logistic regression and the Cochran-Armitage trend test. RESULTS: The number of screening episodes recorded over eight years corresponded to 27.0% (95% confidence interval [CI] 26.6-27.3) of the registered catchment, while annual throughput never exceeded 5.2%. Mean monthly screening volume declined from 264.5 tests in the pre-pandemic period (2018-2019) to 88.6 during the pandemic (2020-2021; IRR 0.335, 95% CI 0.177-0.634; 66.5% reduction; p < 0.001), corresponding to an estimated deficit of approximately 3700 tests; the interrupted time-series estimated an immediate 86% reduction at lockdown onset. Activity recovered to 61% of the pre-pandemic rate during the post-pandemic recovery (2022-2023; IRR 0.614, 95% CI 0.482-0.783) and to 90% in the HPV-primary era (2024-2025; IRR 0.898, 95% CI 0.733-1.100), coinciding with the transition to primary HPV screening. All primary HPV tests produced valid results, compared with an annual unsatisfactory-sample rate of 2.9-4.2% during primary cytology. Cytological positivity remained stable during 2018-2023, and the cytological high-grade squamous intraepithelial lesion (HSIL) detection rate per 1000 screened did not change significantly during the pandemic, although absolute HSIL detections declined with screening volume. In 2024-2025, HR-HPV positivity was 22.8% (1301/5700; 95% CI 21.8-23.9), and 47.9% of HPV-positive women had abnormal reflex cytology. CONCLUSIONS: The pandemic substantially reduced screening activity at a provider already operating with low throughput relative to its registered catchment. Activity subsequently returned to near pre-pandemic levels during the period coinciding with the introduction of primary HPV screening, which also improved primary-sample adequacy. However, the absence of persistent patient linkage and of follow-up data from colposcopy, histology and treatment precluded estimation of population-based coverage, screening intervals and detection of histologically confirmed cervical intraepithelial neoplasia grade 3 or worse (CIN3+). The findings support population-based invitation and recall, clearly defined age-specific screening and follow-up algorithms, self-sampling, targeted catch-up after pandemic-related delays and longitudinal evaluation using histologically confirmed CIN3+ as the principal clinical endpoint.