Diagnostic performance of a SARS-CoV-2 rapid antigen test in a large, Norwegian cohort.

BACKGROUND: Rapid antigen tests (RATs) may be included in national strategies for handling the SARS-CoV-2 pandemic, as they provide test results rapidly, are easily performed outside laboratories, and enable immediate contract tracing. However, before implementation further clinical evaluation of test sensitivity is warranted. OBJECTIVES: To examine the performance of Abbott's Panbio™ COVID-19 Ag Rapid Test Device for SARS-CoV-2 testing in a low to medium prevalence setting in Norway. STUDY DESIGN: A prospective study comparing the results of the Panbio RAT with PCR in 4857 parallel samples collected at a SARS-CoV-2 test station in Oslo, and from COVID-19 outbreaks in six Norwegian municipalities. RESULTS: A total of 4857 cases were included in the study; 3991 and 866 cases from the test station and the outbreak municipalities, respectively. The prevalence at the test station in Oslo was 6.3 %, and the overall sensitivity of the RAT was 74 %. Increased sensitivity was observed in patients who experienced symptoms (79 %) and when considering samples with viral loads above estimated level of infectivity (84 %), while it was lower in asymptomatic persons (55 %). In the outbreak municipalities, the overall prevalence was 6.9 %, and the total sensitivity of the RAT was 70 %. CONCLUSIONS: Our results indicate that the test correctly identified most infectious individuals. Nevertheless, the sensitivity is considerably lower than for PCR, and it is important that the limitations of the test are kept in mind in the follow-up of tested individuals.

Prevalence of positive screening test results and agreement between cytology and human papillomavirus testing in primary cervical cancer screening in North-Western Romania.

Using data from a pilot study conducted in North-Western Romania, we aimed to estimate the prevalence of abnormal cytology and positive high-risk human papillomavirus (hr-HPV) test results in an ethnically diverse screening population and to assess the agreement between cytology and hr-HPV testing to evaluate the feasibility of integrating the latter as a primary test in the national cervical cancer screening program. The cross-sectional pilot study included Roma women, other ethnic minorities, and women in rural remote areas. Samples were taken for liquid-based cytology and hr-HPV testing (Hybrid Capture 2 DNA test) by a mobile health unit. The prevalence of positive screening results and the agreement between cytology and hr-HPV testing were estimated by κ coefficient. A total of 1019 women were included in the study. The population prevalence of positive screening results was similar for both tests (12%). The prevalence of abnormal cytology increased with increasing age, whereas the prevalence of positive hr-HPV test showed a bimodal age pattern. Substantial differences in the prevalence of abnormal cytology were found by ethnicity, with highest prevalence in Romanian women (14%), followed by Roma women (6%) and women of other ethnicities (5%) (P = 0.002). Similar ethnic differences in the prevalence of positive hr-HPV test were not observed. The overall agreement of positive screening results between the two methods was fair (κ = 0.25; 95% confidence interval = 0.18-0.30, P < 0.001) and ranged from poor to substantial depending on the age group. The prevalence of abnormal cytology result was high and similar to the prevalence of positive hr-HPV test result, which could allow for the implementation of hr-HPV testing as a primary test in the cervical cancer screening program in Romania.

HPV Testing for Cervical Cancer in Romania: High-Risk HPV Prevalence among Ethnic Subpopulations and Regions.

BACKGROUND: Romania has had one of the highest rates of cervical cancer incidence and mortality in Europe for decades. Data on the high-risk human papillomavirus (hrHPV) prevalence within the Romanian population are crucial for cervical cancer intervention in high risk groups. The aim of this study was to determine the prevalence of hrHPV infection in Romania, identifying high-risk areas for cervical cancer prevention efforts. METHODS: The target population of this study were women of all forms in Romania, including ethnic minorities, women from urban and rural areas, and women in various regions. Women with no history of precancerous or cancerous lesions were offered hrHPV screening. The specimens were tested with Hybrid Capture 2 (HC2) DNA test. Age-standardized hrHPV prevalence rates with 95% confidence intervals (CI) were estimated. RESULTS: hrHPV results of 2060 women aged 18 to 70 years were analyzed. The highest hrHPV prevalence rates were observed among: Romanians (17.9%; 95 CI: 15.5-20.7%), Hungarians (16.6%; 95% CI: 13.1-20.8%), Russians (15.6%; 95% CI: 11.3-21.3%), women living in North (19.2%; 95% CI: 16.5-22.3%), and West regions (23.0%; 95 CI: 18.6-28.0%), and women living in urban areas (20.0%; 95 CI: 18.5-28.0%). hrHPV prevalence rates were lower for the Roma population (7.8%; 95% CI: 4.7-12.5%). CONCLUSIONS: These hrHPV prevalence rates in a high cervical cancer incidence country provide baseline information for targeted cervical cancer intervention strategies as well as a baseline to measure the impact of hrHPV vaccination in the future.

Correction to: Attendance to cervical cancer screening among Roma and non-Roma women living in North-Western region of Romania.

Romania has Europe's highest incidence and mortality rates of cervical cancer. Participation in the national cervical cancer-screening programme is low, especially among minority Roma women.

Psychological effect of cervical cancer screening when changing primary screening method from cytology to high-risk human papilloma virus testing.

From 2015, Norway has implemented high-risk human papilloma virus (hrHPV) testing in primary screening for cervical cancer. Women aged 34-69 years, living in four counties, have been pseudo-randomly assigned (1:1 randomization) to either hrHPV testing every 5 years (followed by cytology if hrHPV is positive), or cytology testing every 3 years (followed by hrHPV testing if low-grade cytology is detected). We compared anxiety and depression scores among participants by screening arm and results. In total, 1,008 women answered a structured questionnaire that included the validated Patient Health Questionnaire-4 (PHQ-4). The Relative Risk Ratio (RRR) of mild vs. normal anxiety and depression scores, and moderate/severe vs. normal anxiety and depression scores, were estimated by multinomial logistic regression with 95% confidence intervals (95% CIs). Compared to women who were screened with cytology, women randomized to hrHPV testing were not more likely to have mild anxiety and depression scores (RRR 0.96, CI 0.70-1.31) nor more likely to have moderate/severe anxiety and depression scores (RRR 1.14, CI 0.65-2.02). Women with five different combinations of abnormal screening test results were not more likely to have mild or moderate/severe vs. normal anxiety and depression scores than women with normal screening results. The likelihood of having abnormal long-term (4-24 months after the screening) anxiety or depression scores among women 34 years and older was not affected by screening method or screening results. The results of our study suggest that a change to hrHPV testing in primary screening would not increase psychological distress among participants.

Attendance to cervical cancer screening among Roma and non-Roma women living in North-Western region of Romania.

OBJECTIVES: Romania has Europe's highest incidence and mortality rates of cervical cancer. Participation in the national cervical cancer-screening programme is low, especially among minority Roma women. METHODS: We conducted a cross-sectional study, using a structured questionnaire aiming to quantify reasons for screening attendance among women in North-Western region of Romania. RESULTS: 980 women were enrolled in this study. Data were analysed using logistic regression, estimating odds ratios (OR) and 95% confidence intervals (CI). This study revealed that Roma women (46%) attended screening less frequently that non-Roma women (63%),; however, ethnicity in itself was not associated with screening attendance. Instead we found that attendance to the cervical cancer screening programme was determined by having ever heard about a screening opportunity (OR 5.90, 95% CI 3.76-9.27) and having three or more sex partners (OR 5.99, 95% CI 1.71-21.04). CONCLUSIONS: We concluded that information about the screening programme's existence and its rationale does not reach the women targeted for screening sufficiently and argue that a process of user involvement aiming to build contact, interaction and cooperation between the programme and its potential participants is warranted.

Controversies about cervical cancer screening: A qualitative study of Roma women's (non)participation in cervical cancer screening in Romania.

Romania has Europe's highest incidence and mortality of cervical cancer. While a free national cervical cancer-screening programme has been in operation since 2012, participation in the programme is low, particularly in minority populations. The aim of this study was to explore Roma women's (non)participation in the programme from women's own perspectives and those of healthcare providers and policy makers. We carried out fieldwork for a period of 125 days in 2015/16 involving 144 study participants in Cluj and Bucharest counties. Fieldwork entailed participant observation, qualitative interviewing and focus group discussions. A striking finding was that screening providers and Roma women had highly different takes on the national screening programme. We identified four fundamental questions about which there was considerable disagreement between them: whether a free national screening programme existed in the first place, whether Roma women were meant to be included in the programme if it did, whether Roma women wanted to take part in screening, and to what degree screening participation would really benefit women's health. On the background of insights from actor-network theory, the article discusses to what degree the programme could be said to speak to the interest of its intended Roma public, and considers the controversies in light of the literature on patient centred care and user involvement in health care. The paper contributes to the understanding of the health and health-related circumstances of the largest minority in Europe. It also problematizes the use of the concept of "barriers" in research into participation in cancer screening, and exemplifies how user involvement can potentially help transform and improve screening programmes.

Impact of scheduled appointments on cervical screening participation in Norway: a randomised intervention.

BACKGROUND: The main barrier to optimal effect in many established population-based screening programmes against cervical cancer is low participation. In Norway, a routine health service integrated population-based screening programme has been running since 1995, using open invitations and reminders. The aim of this randomised health service study was to pilot scheduled appointments and assess their potential for increased participation. METHODS: Within the national screening programme, we randomised 1087 women overdue for screening to receive invitations with scheduled appointments (intervention) or the standard open reminders (control). Letters were sent 2-4 weeks before the scheduled appointments at three centres: a midwife clinic, a public healthcare centre and a general practitioner centre. The primary outcome was participation at 6 months of follow-up. Secondary outcomes were participation at 1 and 3 months. Risk ratios (RRs) overall, and stratified by screening centre, age group and previous participation, were calculated using log-binomial regression. RESULTS: At 6 months, 20% of the 510 women in the control group and 37% of the 526 women in the intervention group had participated in screening, excluding 51 women in total from analysis due to participation just before invitation and therefore not yet visible in the central records. The RR for participation at 6 months was 1.9 (95% CI 1.5 to 2.3). There was no significant heterogeneity between centres or age groups. Participation increased among women both with (RR 1.7; 95% CI 1.4 to 2.1) and without (RR 3.5; 95% CI 1.3 to 9.2) previous participation. The RRs for participation at 1 and 3 months were 4.0 (95% CI 2.6 to 6.2) and 2.7 (95% CI 2.1 to 3.5), respectively. CONCLUSIONS: Scheduled appointments increased screening participation consistently across all target ages and screening centres among women overdue for screening. Participation increased also among women with no previous records of cervical screening.