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

Cervical screening uptake is decreasing in the UK, with only 67.5% of those eligible under 50 years old attending in 2022. Barriers include restricted access to screening appointments and poor acceptability of the speculum examination. Urine self-sampling is an alternative cervical screening method that has the potential to improve uptake. To determine the clinical performance and acceptability of human papillomavirus (HPV)-tested urine for cervical screening in a UK general screening population. Prospective, cross-sectional diagnostic test accuracy study in North-West England. Urine was self-collected using a first-void urine (FVU) collection device (DNA Genotek Colli-Pee® 10 ml with urine conservation medium) before obtaining matched routine cervical screening samples. HPV testing used Roche Cobas® 8800 at cervical sample thresholds. A questionnaire evaluated urine self-sampling acceptability. HPV-positive cervical samples underwent reflex cytology, managed under standard NHS protocols, and clinical outcomes were collected. In total, 1517 participants provided matched urine and cervical samples. There were 207 of 1517 (13.6%) cervical and 245 of 1517 (16.2%) urine samples that were HPV positive with a 1.6% (n = 25/1517) incidence of cervical intraepithelial neoplasia (CIN)2+ following colposcopic assessment (n = 80). The specificity of urine was non-inferior (P = 0.0004) to the specificity of cervical samples at 85.19% (95% confidence interval [CI] = 83.28 to 86.95) versus 87.80% (95% CI = 86.03 to 89.42), giving a relative specificity of 0.97 (95% CI = 0.95 to 0.99). Urine detected 24 of 25 (96.0%) participants with CIN2+. In the future, 41.6% (n = 575/1382) of participants would prefer current cervical screening, compared with 30.0% (n = 414/1382) with no preference and 28.4% (n = 393/1382) preferring urine self-sampling. HPV-tested urine showed non-inferior specificity to cervical samples in a general screening population. Urine self-sampling was acceptable to current attenders but some prefer traditional screening, making choice an important consideration for policymakers.

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.

Screening for cervical cancer

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.

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.

BackgroundAccording to international guidelines, Human Papillomavirus (HPV) DNA tests represent a valid alternative to Pap Test for primary cervical cancer screening, provided that they guarantee balanced clinical sensitivity and specificity for cervical intraepithelial neoplasia grade 2 or more (CIN2+) lesions. The study aimed to assess whether HPV Selfy (Ulisse BioMed – Trieste, Italy), a full-genotyping HPV DNA test that detects and differentiates 14 high-risk HPV (HR-HPV) types, meets the criteria for primary cervical cancer screening described in the international guidelines, on clinician-collected as well as on self-collected samples.MethodsFor each participant woman, consecutively referring to Azienda Sanitaria Universitaria Giuliano Isontina (Trieste, Italy) and CRO—National Cancer Institute (Aviano, Italy) for the cervical cancer screening program, the following samples were tested: (a) a clinician-collected cervical specimen, analyzed with the reference test (Hybrid Capture®2 test, HC2) and HPV Selfy; and (b) a self-collected vaginal sample, analyzed with HPV Selfy. Enrolled women were also asked to fulfill a questionnaire about self-sampling acceptability. As required by guidelines, a non-inferiority test was conducted to compare the clinical performance of the test under evaluation with its reference test.ResultsHPV Selfy clinical sensitivity and specificity resulted non-inferior to those of HC2. By analysis of a total of 889 cervical liquid-based cytology samples from a screening population, of which 98 were from women with CIN2+, HPV Selfy showed relative sensitivity and specificity for CIN2+ of 0.98 and 1.00 respectively (non-inferiority score test: P = 0.01747 and P = 0.00414, respectively); the test reached adequate intra- and inter-laboratory reproducibility. Moreover, we demonstrated that the performance of HPV Selfy on self-collected vaginal samples was non-inferior to the performance obtained on clinician-collected cervical specimen (0.92 relative sensitivity and 0.97 relative specificity). Finally, through HPV Selfy genotyping, we were able to describe HPV types prevalence in the study population.ConclusionsHPV Selfy fulfills all the requirements of the international Meijer’s guidelines and has been clinically validated for primary cervical cancer screening purposes. Moreover, HPV Selfy has also been validated for self-sampling according to VALHUDES guidelines. Therefore, at date, HPV Selfy is the only full-genotyping test validated both for screening purposes and for self-sampling.Trial registration ASUGI Trieste n. 16008/2018; CRO Aviano n.17149/2018

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.

The aim of this survey was to assess the prevalence and distribution of oncogenic human papillomavirus (HPV) genotypes in women who underwent screening for cervical cancer in Italy. The correlation of genotypes with the cytological results was also evaluated. Cervical samples were collected from 9,947 self-referring women for cervical cancer screening. Participants were screened by liquid-based cytology and high-risk HPV testing using the Hybrid Capture 2 test. Positive samples were genotyped by PCR. Samples (1,474; 14.8%) were positive for high-risk HPV. The prevalence was 29.4% in the 15-19 years-group, decreasing progressively to 6.1% at 50-54 years of age and increasing to 12.2% in those aged over 65 years. HPV 16 was the genotype detected most frequently followed by HPV 31, HPV 18, HPV 56, and HPV 51. HPV 16 or 18 were present in 4% of women with normal cytology and both were detected contemporarily in only 14 women. Twenty-two percent of atypical squamous cells, 26% of low-grade and 56% of high-grade squamous intraepithelial lesions at cytology were positive for HPV 16 and/or 18. The prevalence of HPV infection in Italy is in agreement with that reported worldwide. HPV 16 was the prevalent genotype. The concomitant infection with HPV 16 and HPV 18 (vaccine targets) was found rarely. Apart from HPV 16 and 18, there was a substantial presence of HPV genotypes against which the vaccines available currently have shown cross-protection efficacy. The findings of this study may contribute to reliable predictions on the potential efficacy of an HPV vaccine in clinical practice.

Human Papillomavirus (HPV) is the most common sexually transmitted infection in the USA, with over 14 million people acquiring HPV each year. HPV is also the cause of most anogenital cancers. About 90% of HPV infections spontaneously resolve over 3 years. However, about 10% remain as persistent infection defined as repeatedly detected in cervical samples. As HPV is controlled by local and systemic immune responses, individuals with immunosuppression are at risk for cervical cancer. It is hypothesized that immunosuppressed individuals are more likely to have HPV persistence, which is necessary for malignant transformation. Accordingly, women with rheumatic diseases such as SLE and RA are likely vulnerable to HPV infection and the progression of cervical disease. The HPV vaccine, given as a series of vaccinations, is safe and effective that can prevent HPV infection and cervical cancer. There is no contraindication to HPV vaccination for women to age 26 with rheumatic disease, as it is not live. As in the general population, timing is key for the efficacy of the HPV vaccine as the goal is to vaccinate prior to sexual debut and exposure to HPV. There are no formal recommendations for cervical cancer screening in women with rheumatic disease but recommendations for the HIV-positive population can be adopted, meaning to screen with a Pap test annually for three consecutive years and if all normal, to extend the interval to every 3 years with the option of co-testing with HPV at 30 years and older.

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...

BackgroundDetection of genital HPV DNA is recommended as an important strategy for modern cervical cancer screening. Challenges include access to services, the reliance on cervical samples taken by clinicians, and patient’s preference regarding provider gender. The objective of this research was to determine the acceptability, feasibility and performance of alternative self-collected vaginal samples for HPV detection among Ghanaian women.MethodsA comparative frequency-matched study was conducted in a systematic (1:5) sample of women attending HIV and outpatient clinics in the Cape Coast Teaching Hospital, Ghana. Participants were instructed on self-collection (SC) of vaginal samples using the careHPV brush and a clinician-collected (CC) cervical sample was obtained using a similar brush. Paired specimens were tested for HPV DNA (14 high-risk types) by careHPV assay (Qiagen) and by HPV genotyping (Anyplex II, Seegene).ResultsOverall, 194 women of mean age 44.1 years (SD ± 11.3) were enrolled and 191 paired SC and CC results were analysed. The overall HPV detection concordance was 94.2% (95%CI: 89.9–97.1), Kappa value of 0.88 (p < 0.0001), showing excellent agreement. This agreement was similar between HIV positive (93.8%) and negative (94.7%) women. Sensitivity and specificity of SC compared to CC were 92.6% (95%CI: 85.3–97.0) and 95.9% (95%CI: 89.8–98.8) respectively. The highest sensitivity was among HIV positive women (95.7%, 95%CI: 88.0–99.1) and highest specificity among HIV negative women (98.6%, 95%CI: 92.4–100). Overall, 76.3% women found SC very easy/easy to obtain, 57.7% preferred SC to CC and 61.9% felt SC would increase their likelihood to access cervical cancer screening.ConclusionsThe feasibility, acceptability and performance of SC using careHPV support the use of this alternative form of HPV screening among Ghanaian women. This could be a potential new affordable strategy to improve uptake of the national cervical cancer screening program.

Human papillomavirus (HPV) DNA testing can be used to identify women at risk of the development of cervical cancer. The cost-effectiveness of HPV screening is dependent on the type-specific HPV prevalence in the general population. The present study describes the prevalence and spectrum of high-risk HPV types found in a large real-life population-based HPV screening trial undertaken entirely within the cervical screening program offered to middle-aged Swedish women. Cervical brush samples from 6,123 women aged 32-38 years were analyzed using a general HPV primer (GP5+/6+) polymerase chain reaction-enzyme immunoassay (PCR-EIA) combined with reverse dot-blot hybridization for confirmation and HPV typing by a single assay. In this study, 6.8% (95% CI 6.2-7.5) (417/6,123) were confirmed as high-risk HPV positive. Infections with 13 different high-risk HPV types were detected, of which HPV 16 was the most prevalent type (2.1%; 128/6,123), followed by HPV 31 (1.1%; 67/6,123). Any one of the HPV types 18, 33, 35, 39, 45, 51, 52, 56, 58, 59, or 66 was detected in 3.6% (223/6,123) of the women. Infection with two, three, and five types simultaneously was identified in 32, 5, and 1 women, respectively. The combination of PCR-EIA as a screening test and reverse dot-blot hybridization as a confirmatory test, was found to be readily applicable to a real-life population-based cervical screening. The type-specific HPV prevalence found support in previous modeling studies suggesting that HPV screening may be a favorable cervical screening strategy.

Cervical cancer screening primarily uses the human papillomavirus (HPV) test with partial genotyping (HPV 16/18) and liquid-based cytology using ThinPrep cytology test (TCT) to triage women with a positive HPV test. Although quantitative DNA ploidy analysis has shown reliability, its integration into screening guidelines as a triage test, compared to partial genotyping and TCT, has not been fully established. The objective of the study is to evaluate the clinical utility of DNA ploidy analysis as a triage test for women with a positive HPV test in primary screening, comparing it to HPV 16/18 genotyping and TCT. We retrospectively analyzed data from 335 women aged ≥18 years who participated in a cervical cancer screening program at Shanghai Ruijin Hospital and underwent triage using HPV 16/18, TCT, and DNA ploidy testing. The sensitivities and specificities of these methods, both individually and combined, were evaluated. The test showed sensitivities and specificities of 35.4% and 76.1% for HPV 16/18, 29.2% and 88.2% for TCT, and 93.8% and 92.7% for DNA ploidy, respectively. Combining these tests improved outcomes, with DNA ploidy plus HPV 16/18 genotyping showing enhanced sensitivity and high specificity. Notably, DNA ploidy alone identified high-grade squamous intraepithelial lesions (HSIL) and cervical cancer with a higher detection rate and lower positivity rate in triage than HPV 16/18 and TCT. DNA ploidy analysis demonstrated superior specificity and sensitivity in the triage of women with positive HPV test results, offering a more effective alternative for detecting high-grade lesions and cervical cancer. These findings support the potential of integrating DNA ploidy into current cervical cancer screening protocols to enhance triage effectiveness and reduce unnecessary colposcopy referrals.

BackgroundHuman papillomavirus (HPV) is the main etiological agent of cervical cancer, the third most common cancer among women globally and the second most frequent in Mexico. Persistent infection with high-risk HPV genotypes is associated with premalignant lesions and cervical cancer development. HPVs considered as low risk or not yet classified, are often found in coinfection with different HPV genotypes. Indeed, HPV62 is one of the most prevalent HPV detected in some countries, but there is limited information about its prevalence in other regions and there are no HPV62 variants currently described. The aim of this study was to determine the prevalence of HPV62 in cervical samples from Mexican women and to identify mutations in the L1, E6 and E7 genes, which have never been reported in our population.MethodsHPV screening was performed by Cobas HPV Test in women who attended prevention health programs and dysplasia clinics. All HPV positive samples (n = 491) and 87 additional cervical cancer samples were then genotyped with Linear Array HPV Genotyping test. Some samples were selected to corroborate genotyping by Next-Generation sequencing. On the other hand, nucleotide changes in L1, E6 and E7 genes were determined using PCR, Sanger sequencing and analysis with the CLC-MainWorkbench 7.6.1 software. L1 protein structure was predicted with the I-TASSER server.ResultsUsing Linear Array, HPV62 prevalence was 7.6% in general population, 8% in Cervical Intraepithelial Neoplasia grade 1 (CIN1) samples and 4.6% in cervical samples. The presence of HPV62 was confirmed with Next-Generation sequencing. Regarding L1 gene, novel sequence variations were detected, but they did not alter the tertiary structure of the protein. Moreover, several nucleotide substitutions were found in E6 and E7 genes compared to reference HPV62 genomic sequence. Specifically, three non-synonymous sequence variations were detected, two in E6 and one in E7.ConclusionsHPV62 is a frequent HPV genotype found mainly in general population and in women with CIN1, and in 90.5% of the cases it was found in coinfection with other HPVs. Novel nucleotide changes in its L1, E6 and E7 genes were detected, some of them lead to changes in the protein sequence.

Correlation of Cobas HPV Testing and Follow-Up Biopsies in Women with Negative Pap Tests