Corrigendum to “History of the use of HPV testing in cervical screening and in the management of abnormal cervical screening results” [J. Clin. Virol. 45 (1) (2009) S3–S12

HPV Genotype Detection Using Hybrid Capture Sample Preparation Combined with Whole Genome Amplification and Multiplex Detection with Luminex XMAP

Screening for cervical cancer

Cervical cancer (CC) screening shifted from Pap-smear to human papillomavirus (HPV) testing HPV with and without a self-sampling HPV-test in Thailand. Few studies have reported the initial outcomes of such a transition. This study aims to explore CC screening rate, CC detection and compare the CC detection rate by HPV with and without self-sampling methods in Krabi, province. A retrospective study was conducted from 1st October 2023 to 30th September 2024. A total of 11,925 women's records were retrieved. Information on demographic, screening results and cancer diagnosis was retrieved from the Krabi provincial hospital. Different proportions of CC detections and self-test collection based on demographic features were tested using chi-square and Fisher's exact tests. Result: CC screening rate was 42.4%: 10,619 (89%) of women had an HPV test and 1,306 (11%) had a Pap-smear test. The screening rate was 30.2% in 2023 and 52.1% in 2024. With regard to age, occupation, and health insurance schemes there was a significant difference in the proportion of those taking the self- collection test. Religion showed non-significance difference in the proportion of self-sampling test in relation to religion. CC detection was 3% among women who underwent the Pap-smear test and 0.12% for those who performed the HPV test. There is a significant difference in CC detection between the HPV with and without a self-sampling test. CC screening with HPV testing, especially with self-sampling, showed a promising approach to increasing CC screening uptake in the population. The rate of CC detection through self-sampling was lower in the early years of implementation compared to non-self-sampling methods. Ensuring the correct performance of self-sampling should be carefully considered and monitored in the future.

BACKGROUND In the United States, human papillomavirus (HPV) and Papanicolaou (Pap) testing (cotesting) for cervical screening in women ages 30 to 65 years is the preferred strategy, and cytology alone is acceptable. Recently, a proprietary automated test for identifying high-risk HPV types for primary cervical screening was approved by the US Food and Drug Administration. The objective of the current study was to document extensive cervical screening among these screening options. METHODS To investigate the sensitivity of various testing options for biopsy-proven cervical intraepithelial neoplasia grade 3 or worse (≥CIN3) and cancer, the authors reviewed 256,648 deidentified results from women ages 30 to 65 years at the time of cotest who had a cervical biopsy specimen obtained within 1 year of the cotest. RESULTS A positive cotest result was more sensitive (98.8%; 4040 of 4090 cotests) for diagnosing ≥CIN3 than either a positive HPV-only test (94%; 3845 of 4090 HPV-only tests) or a positive Pap-only test (91.3%; 3734 of 4090 Pap-only tests; P < .0001). A positive Pap-only result was more specific (26.3%; 66,145 of 251,715 Pap-only tests) for diagnosing ≥CIN3 than a positive HPV-only test (25.6%; 64,625 of 252,556 HPV-only tests) or a positive cotest (10.9%; 27,578 of 252,558 cotests; P < .0001). Of 526 cervical cancers, 98 (18.6%) were HPV-only negative, 64 (12.2%) were Pap-only negative, and 29 (5.5%) were cotest negative. CONCLUSIONS Compared with HPV-only testing, cotesting was more sensitive for the detection of ≥CIN3 in women ages 30 to 65 years. The current data suggest that approximately 19% of women with cervical cancer may be misdiagnosed by an HPV-only cervical screen. It is important to consider these data as the guidelines for cervical cancer screening undergo revision. Cancer (Cancer Cytopathol) 2015;123:282–8. © 2015 The Authors. Cancer Cytopathology published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Background: Multiple studies have shown that African-American and Hispanic women have limited and inadequate knowledge about cervical cancer (CC) and CC screening, which contributes to morbidity and mortality disparities. Access to knowledge, education, and other socio-political factors are social determinants of health that serve to shape individual health behavior knowledge. Better CC knowledge has been shown to increase screening uptake. Methods: In the present study, we specified unique subgroups regarding CC prevention behaviors in a sample of African- American and Hispanic women (N = 328) recruited from a minority-serving higher education institution. Results: Latent class analysis identified 3 unique salient subgroups based on the indicators: CC Screening Adherers and Vaccinators (14%), CC Screening Adherers (48%), and CC Prevention Non-adherers (38%). We found probable variations within the classes regarding screening behavior, human papillomavirus (HPV) vaccination status, and race/ethnicity. Women reporting higher guideline knowledge were 11 times more likely to be classified as CC Screening Adherers and Vaccinators than CC Prevention Non-adherers. Additionally, women who specifically understood that HPV causes cervical cancer were 16 and 9 times more likely to be classified as CC Screening Adherers and Vaccinators and CC Screening Adherers than to be classified as CC Prevention Nonadherers. Conclusion: Addressing cervical cancer knowledge remains an important intervention strategy in these populations to increase CC screening uptake.

پاپیلوما ویروس های انسانی اپی تلیال پوست و مخاط را آلوده می کنند و باعث ایجاد جراحات نئوپلازی خوش خیم و بد خیم می شوند. در کشور های در حال توسعه، پاپیلوماویروس ها عامل ایجاد 250000 مرگ در سال به علت سرطان سرویکس می باشند این مساله مهم بهداشت عمومی، اهمیت تحقیق بر روی روش های تشخیصی پاپیلوماویروس ها را نشان می دهد. در این پژوهش، ترکیبی از دو روش تکثیر با واکنش زنجیره ای پلیمراز (PCR) و بررسی پلی مورفیسم طول قطعات با آنزیم های محدودگر (RFLP) استفاده شد تا تیپ های پاپیلوماویروس های انسانی در نمونه های سرطان سرویکس مشخص شوند. دو نمونه از پنج نمونه از لحاظ وجود پاپیلوماویروس های انسانی مثبت بودند که یک نمونه تیپ 16 و دیگری تیپ 18 بود. این روش می تواند شناسایی حساس طیف وسیعی از پاپیلوماویروس های ژنیتال را تسهیل کند.

The development of a quality assurance programme for HPV testing within the UK NHS cervical screening LBC/HPV studies

ObjectivesMozambique has one of the highest rates of cervical cancer globally. The objective of our study is to implement integrated cervical cancer screening and voluntary family planning to scale up...

Background: There is a paucity of studies exploring women living with HIV's (WLWH) experiences relating to human papillomavirus (HPV) self-sampling as cervical cancer (CC) screening approach, either at the clinic or at the home setting, using qualitative methods. Our study explored facilitators and barriers to HPV self-sampling as a CC screening approach among human immunodeficiency virus (HIV)-infected women, as supported by the new WHO guidelines of using the HPV test as a screening modality. Methods: The study was guided by the health promotion model (HPM), which helps individuals achieve higher levels of well-being. The phenomenology design was used to explore the deeper facilitators and barriers of women regarding self-sampling, either at home or in clinical settings, at Luweero District Hospital, Uganda. The in-depth interview (IDI) guide was translated from English to Luganda. Qualitative data analysis was guided by content analysis techniques. The transcripts were coded in NVivo 20.7.0. The coded text was used to generate categories of analytically meaningful data that guided the formation of themes, the interpretation of results, and the final write-up. Results: WLWH were motivated to screen for HPV using the clinic-based approach because of perceived early diagnosis and treatment, visualization of the cervix, and free service, while reduced distance, privacy and the smooth sample collection kit were motivators for the home-based approach. A barrier that cut across the two HPV self-sampling approaches was a lack of knowledge about HPV. The barriers to clinic-based HPV self-sampling screening included lack of privacy, perceived painful procedures for visual inception under acetic acid (VIA), and fear of finding the disease. Stigma and discrimination were reported as the major barriers to the home-based HPV self-sampling approach. The major reasons why some WLWH refused to screen were fear of finding the disease, stress, and financial disruptions related to being diagnosed with CC disease. Conclusions: Therefore, early diagnosis for HPV and CC enhances clinic-based HPV self-sampling, while privacy enhances the home-based HPV self-sampling approach. However, fear of finding a disease and the lack of knowledge of HPV and CC hinders HPV self-sampling. Finally, designing pre- and post-testing counselling programs in HIV care is likely to increase the demand for HPV self-sampling.

Human papillomavirus (HPV) self-collection increases cervical cancer screening uptake among women underscreened for cervical cancer, particularly those from marginalized low-income and racial and ethnic backgrounds. Underscreened women are also at high risk for other sexually transmitted infections (STIs) that can be similarly screened via self-collection. To evaluate an intervention streamlining testing for other STIs alongside HPV self-collected samples among low-income women. This is a secondary analysis of the My Body, My Test-3 study, a randomized clinical trial testing a mailed self-collection intervention to improve cervical cancer screening. The My Body, My Test-3 study was conducted from April 2016 to December 2019 in 22 counties in North Carolina among low-income women overdue for cervical cancer screening. This analysis included participants randomized to the trial intervention group with valid STI and HPV results. Data analysis occurred from October 2024 to February 2025. The intervention included a mailed self-collection kit and instructions to self-collect a cervicovaginal sample. Samples were tested for other STIs and HPV using the Aptima assay. The primary outcome was a positive test result for other STIs (including chlamydia, gonorrhea, and trichomoniasis). A risk factor analysis was conducted to identify factors associated with testing positive for other STIs. Secondary outcomes included rate of follow-up care and perceptions of self-collection among participants with positive STI results. Among 327 participants (median [IQR] age, 42 [25-63] years; 38 [8.6%] Hispanic, 146 [44.7%] non-Hispanic Black, and 133 [40.7%] non-Hispanic White), 51 (15.6%) tested positive for other STIs and 51 (15.6%) tested positive for HPV; 7 (2.1%) tested positive for both. Risk factors for other STIs included non-Hispanic Black race and ethnicity compared with non-Hispanic White race and ethnicity (adjusted odds ratio [aOR], 4.1; 95% CI, 1.5-11.6), having 2 or more sexual partners in the last year compared with having none (aOR, 5.7; 95% CI, 1.0-31.4), single marital status compared with married or partnered status (aOR, 5.6; 95% CI, 1.1-27.9), and current smoking compared with none (aOR, 4.1; 95% CI, 1.7-10.4). Among participants who tested positive for other STIs, 34 (66.7%) received follow-up care. Most participants (130 [84.4%]) preferred testing for both HPV and other STIs in the future. In this secondary analysis of a randomized clinical trial of 327 participants, nearly 1 in 6 tested positive for other STIs via streamlined testing in a mailed HPV self-collection intervention. Self-collection may improve both cervical cancer and STI screening for women from marginalized backgrounds. ClinicalTrials.gov Identifier: NCT02651883.

Testing for human papillomavirus (HPV) is used in the triage of women with a cervical cytology of atypical squamous cells of undetermined significance (ASCUS). A fluorescent in situ hybridization assay was developed for the detection of HPV using the catalyzed receptor deposition technique (HPV-CARD). In this study, the utility of this assay was tested for the detection of HPV in liquid-based cervical cytology specimens. A total of 195 liquid-based cytology specimens were analyzed using the HPV-CARD assay. The results from the assay were compared with HPV polymerase chain reaction (PCR) and typing results. The number of HPV-infected cells and the staining pattern was correlated with the cytology classification. A 91% concordance between HPV-CARD and PCR was observed for the detection of high-risk HPV viruses. A 78% concordance was observed for specimens that were negative for HPV. In ASCUS, low-grade squamous intraepithelial lesion (LSIL), and high-grade squamous intraepithelial lesion (HSIL) categories, the average number of HPV-positive cells per slide was 19 cells, 127 cells, and 450 cells, respectively. The number of cells with a punctate staining, suggestive of HPV integration, was 21% in ASCUS, 34% in LSIL, and 46% in HSIL specimens. The results of the current study indicate positive correlations between the severity of the disease and the increased overall quantity of HPV-positive epithelial cells in cervical cytology specimens and accumulation of cells with punctate staining suggestive of integrated HPV. In summary, the developed HPV-CARD assay was found to provide novel information regarding the proportion and staining pattern of HPV-infected epithelial cells in different cytologic categories of cervical specimens.

Incidence of both cervical and oral cancer are high in India. Although there are no organized cervical or oral screening programmes in the country, a number of research projects are ongoing or recently completed. In cervical screening, a number of studies of visual inspection with various aids and studies of human papillomavirus (HPV) testing are in progress. Long-term follow-up of these will inform policy on cervical screening in limited resource countries. A randomized trial of oral visual inspection for cancer or premalignant lesions in 192,053 subjects has been conducted in Kerala, South India. In the trial population as a whole, the study group showed a non-significant 21% reduction in mortality from oral cancer compared with the control group. In users of alcohol, tobacco or both, in which more than 90% of oral cancer deaths occurred, the reduction was a significant 34% (relative risk = 0.66, 95% confidence interval 0.45-0.95). On the basis of these results, screening for oral abnormalities has the potential to prevent 37,000 deaths per year worldwide.

In 2018, the US Preventive Services Task Force updated cervical cancer screening recommendations to allow for screening every 5 years with primary human papillomavirus (HPV) testing in combination with cytology (cotesting) or every 5 years with primary HPV screening alone. Despite these changes, the uptake of primary HPV screening has been lower than expected. The purpose of this study was to evaluate the patient perspective of an integrated health system transition from cotesting to primary HPV testing among a 30- to 65-year-old cohort. Semistructured phone interviews were conducted from July to December 2023 at Kaiser Permanente Colorado with 16 members aged 30-65 years. Interviews asked about reactions to the forthcoming change in cervical cancer screening, personal concern about cervical cancer risk, feedback on patient-facing education materials, and preference on communication timing and modality. Participants reported concerns about cervical cancer screening intervals, primarily the reduction in frequency leading to underdiagnosis of sexually transmitted infections (STIs). Participants recommended defining the rationale for the change to primary HPV testing in the patient education materials. Participants preferred communication about the change in-clinic between practitioner and patient. The interviews identified key themes, including the differentiation between cervical cancer and STI screening methodologies, potential underdiagnosis of STI and cervical cancer, and the rationale supporting primary HPV testing and associated screening intervals. These qualitative findings can inform health systems of potential patient concerns to address when considering the transition from cotesting every 3 years to primary HPV testing every 5 years for cervical cancer screening.

A substantial effect of human papillomavirus (HPV) vaccines on reducing HPV-related cervical disease is essential before modifying clinical practice guidelines in partially vaccinated populations. To determine the population-based cervical intraepithelial neoplasia (CIN) trends when adjusting for changes in cervical screening practices that overlapped with HPV vaccination implementation. The New Mexico HPV Pap Registry, which captures population-based estimates of both cervical screening prevalence and CIN, was used to compute CIN trends from January 1, 2007, to December 31, 2014. Under New Mexico Administrative Code, the New Mexico HPV Pap Registry, a statewide public health surveillance program, receives mandatory reporting of all cervical screening (cytologic and HPV testing) and any cervical, vulvar, and vaginal histopathological findings for all women residing in New Mexico irrespective of outcome. Prespecified outcome measures included low-grade CIN (grade 1 [CIN1]) and high-grade CIN (grade 2 [CIN2] and grade 3 [CIN3]). From 2007 to 2014, a total of 13 520 CIN1, 4296 CIN2, and 2823 CIN3 lesions were diagnosed among female individuals 15 to 29 years old. After adjustment for changes in cervical screening across the period, reductions in the CIN incidence per 100 000 women screened were significant for all grades of CIN among female individuals 15 to 19 years old, dropping from 3468.3 to 1590.6 for CIN1 (annual percentage change [APC], -9.0; 95% CI, -12.0 to -5.8; P < .001), from 896.4 to 414.9 for CIN2 (APC, -10.5; 95% CI, -18.8 to -1.2; P = .03), and from 240.2 to 0 for CIN3 (APC, -41.3; 95% CI, -65.7 to 0.3; P = .05). Reductions in the CIN2 incidence were also significant for women 20 to 24 years old, dropping from 1027.7 to 627.1 (APC, -6.3; 95% CI, -10.9 to -1.4; P = .02). Population-level decreases in CIN among cohorts partially vaccinated for HPV may be considered when clinical practice guidelines for cervical cancer screening are reassessed. Evidence is rapidly growing to suggest that further increases in raising the age to start screening are imminent, one step toward integrating screening and vaccination.

Background: Despite well-defined practice guidelines for management of abnormal cervical cancer (CC) screening results, the incidence of CC is disproportionately higher in Black and Hispanic women compared to White women. Black women experience the highest overall CC mortality rates, irrespective of subtype or stage. Disparities in CC prevention may be related to differential follow-up of abnormal CC screening and delays in CC diagnosis. In a cohort of primarily Black and Hispanic patients, we investigated racial and ethnic disparities in factors associated with colposcopy attendance following abnormal CC screening. Methods: In a large urban OB/GYN clinic in Connecticut, clinical and demographic medical record data was collected for patients with abnormal CC screening results from 2/2021 to 1/2022. Factors related to colposcopy completion were examined for colposcopy indicated patients. In univariate and multivariate analysis (SAS 9.4), we analyzed the relationship between clinical and demographic characteristics and key junctures in the colposcopy referral and completion cascade. Colposcopy scheduling outcomes were compared by race/ethnicity using the Mann-Whitney U test. Analyses of race/ethnicity were stratified by primary language spoken (non-Hispanic Black, Hispanic English-speaking, Hispanic Spanish-speaking, and White/Other). Results: Of the 248 patients indicated for colposcopy, 44% identified as Black, 39% identified as Hispanic, and 18% identified as White/Other. Among Hispanic patients, 62% spoke English and 38% spoke Spanish as their primary language. The majority of colposcopy indicated patients were publicly insured by Medicare or Medicaid. Colposcopy appointments were attended by 86.7% (215) of indicated patients, with 63.3% (157) attending within the guideline recommended interval of 8 weeks from CC screening for high-grade cytology and 90 days for low-grade cytology. In univariate analysis, colposcopy attendance was significantly lower in Black vs. White/Other patients (p&amp;lt;0.05). Multivariate analysis also showed that Black patients experienced the greatest disparity in colposcopy attendance, followed by Hispanic English-speaking patients (p&amp;lt;0.01). Although rates of guideline-concordant colposcopy attendance were lowest in Black and Hispanic English-speaking patients, these differences were not significant as guideline-concordant completion rates decreased across all groups. No significant relationships were found between race/ethnicity and the number of cancellations, no shows, or reschedules of colposcopy appointments. Conclusions: Although we identified significant differences in colposcopy attendance across race/ethnicity, there were no significant differences in guideline-concordant colposcopy attendance or appointment scheduling outcomes related to delays in colposcopy (i.e. cancellation, no show, or reschedule). Future studies on colposcopy delays will focus on multi-level factors that may disproportionately burden racial/ethnic minority groups and lead to disparities in follow-up of abnormal CC screening results. Citation Format: Anisha V. Patel, Guangyu Tong, Beth A. Jones, Raul U. Hernandez-Ramirez, Wanyi Tang, Sarah Megiel, Abigail Girgis, Jamie Foster, Donna Spiegelman, Sangini S. Sheth. Racial and ethnic disparities in follow-up of abnormal cervical cancer screening results [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C124.