Diagnostic Accuracy and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cancer Screening in Eco-nomically Developed Regions: A Prospective Cohort Study in Shanghai, China

Diagnostic Accuracy and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cancer Screening in Eco-nomically Developed Regions: A Prospective Cohort Study in Shanghai, China | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Diagnostic Accuracy and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cancer Screening in Eco-nomically Developed Regions: A Prospective Cohort Study in Shanghai, China Bowen Xu, Jingjing Liu, Hui Li, Tingting Zhang, Fang Li This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7693739/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective To evaluate the diagnostic accuracy and clinical applicability of a novel cervical self-sampling device for HPV genotyping, and to determine the factors influencing patient preference for self-collection methods in economically developed regions. Methods In this prospective paired-sample study conducted at Shanghai East Hospital (September 2024-February 2025), 276 high-risk women from gynecological outpatient clinics under-went sequential cervical sampling: self-collection followed by clinician-administered sampling. Both specimens underwent parallel HPV genotyping analysis using standardized protocols. Using clinician sampling as the reference standard, we calculated diagnostic parameters including sensitivity, specificity, and predictive values with 95% confidence intervals. Patient-reported outcomes (n = 268 valid responses) assessing acceptability, comfort level, and preference were collected through a structured questionnaire. Results The self-sampling method demonstrated excellent concordance with clinician sampling (κ = 0.937; 95% CI:0.89–0.98). Diagnostic performance metrics were as follows: sensitivity 91.4% (83.2–96.5%), specificity 100% (98.2–100%), accuracy 97.5% (94.8–99.0%), positive predictive value 100% (95.0-100%), and negative predictive value 96.5% (93.2–98.5%). While 41.4% of participants initially preferred self-sampling, this proportion increased to 56.7% when considering cost factors. Key determinants for self-sampling preference included: home-based collection comfort (59.2%), perceived pain reduction through self-controlled sampling pressure (57.2%), and privacy preservation (56.6%). Multivariate analysis revealed significant associations between sampling preference and age (p < 0.0001), HPV vaccination status (p = 0.0064), previous screening experience (p = 0.0064), and comfort perception (p < 0.0001). Conclusion The novel self-sampling device achieves diagnostic accuracy comparable to clinician-collected specimens while demonstrating superior patient acceptability. Its ad-vantages in privacy protection, procedural comfort, and cost-effectiveness position it as a promising complementary strategy to enhance cervical cancer screening coverage, particularly among under-screened high-risk populations. Cervical Cancer Screening HPV Self-collection Diagnostic Accuracy Patient-centered Care Screening Adherence Economically Developed Regions Figures Figure 1 Figure 2 1. Introduction 1.1 Pathogenic association between HPV infection and cervical cancer Cervical cancer, the fourth most prevalent malignancy and fourth leading cause of cancer-related mortality in women worldwide [ 1 ], poses a significant threat to global women's health. The World Health Organization (WHO) estimates 604,000 new cases and 349,000 deaths globally in 2022, with cervical cancer ranking as the most frequent female malignancy in 25 countries [ 2 ]. In China, 2022 cancer registry data from the National Cancer Center reported 150,700 new cervical cancer cases among 4,824,700 total cancer diagnoses [ 3 ]. Persistent infection with high-risk human papillomavirus (HR-HPV) genotypes (particularly HPV 16/18) is the primary etiological factor for cervical carcinogenesis. These oncogenic variants induce dysregulation of cervical epithelial cell cycle control mechanisms, ultimately leading to malignant transformation [ 4 – 6 ]. Notably, HPV 16/18 account for 70% of cervical cancer cases globally, while regional data from Henan Province, China, reveals a 75.7% detection rate of HPV 16/58/52 among cervical cancer patients [ 7 ]. The disproportionately higher mortality rates in developing countries, attributable to limited screening resources, underscore the critical role of HPV-based screening in cervical cancer prevention [ 8 ]. 1.2 Clinical value of HPV testing in cervical cancer early detection HPV genotyping has emerged as a cornerstone of cervical cancer screening, demonstrating superior sensitivity and negative predictive value compared to conventional cytological methods such as Pap smears [ 9 ]. This molecular approach enables earlier detection of high-risk HPV infections, thereby facilitating timely interventions to reduce cervical cancer incidence and mortality. Furthermore, HPV genotyping provides critical information for risk stratification through specific high-risk genotype identification, supporting personalized clinical management and surveillance protocols [ 10 ]. In January 2023, China's National Health Commission launched the Accelerating Cervical Cancer Elimination Action Plan (2023–2030), mandating nationwide improvements in cervical cancer prevention systems and comprehensive treatment capabilities. Concurrently, the Chinese Guidelines for Cervical Cancer Screening (I) (2023) established HR-HPV nucleic acid testing as the primary screening modality [ 11 ]. Despite these advancements, current HR-HPV screening implementation in China remains suboptimal, with significant regional disparities in coverage rates. These challenges primarily stem from limited healthcare accessibility and variable patient acceptance of screening procedures. 1.3 Clinical implications and implementation challenges of cervical self-sampling Self-sampling for rapid testing has gained global traction in medical diagnostics, particularly during the COVID-19 pandemic [ 12 ]. Conventional cervical screening methods relying on clinician-collected Pap smears or HPV tests face limitations due to healthcare resource disparities and women's concerns regarding privacy and procedural discomfort, resulting in persistently low screening coverage in underserved regions [ 13 ]. The clinical utility of HPV self-sampling was first demonstrated in 1999 by Hillemanns et al., who reported 93% sensitivity for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions [ 14 ]. Global implementation studies confirm that HPV self-sampling significantly enhances screening accessibility through decentralized specimen collection. Systematic reviews demonstrate that home-based self-sampling programs achieve screening participation rates several-fold higher than traditional clinic-based approaches [ 15 , 16 ]. This strategy has proven particularly effective in hard-to-reach populations, such as Canada's Indigenous communities, where its convenience and privacy advantages overcome cultural barriers to screening participation [ 17 ]. Economic analyses further highlight the cost-effectiveness of self-sampling, prompting large-scale validation studies across low- and middle-income countries (LMICs) in the Americas, Asia, and Africa [ 18 – 22 ]. Recognizing its transformative potential, the World Health Organization (WHO) now endorses self-sampling as a cornerstone strategy for cervical cancer elimination in LMICs [ 23 ]. Despite these advancements, global adoption remains limited. A 2023 landscape analysis revealed that only 35% of 139 countries with formal screening guidelines promote HPV primary screening, with merely 17 nations (35% of HPV-adopting countries) officially recommending self-sampling [ 24 ]. In China, persistent challenges include suboptimal HR-HPV screening rates and pronounced regional disparities in implementation. The integration of self-sampling for HR-HPV nucleic acid detection could address these gaps by leveraging its operational simplicity and privacy protection features, thereby expanding screening coverage and advancing national cervical cancer prevention objectives. We are more interested in understanding whether women in economically developed regions of China, such as Shanghai, where medical conditions are advanced, have the same level of acceptance for self-sampling testing for high-risk HPV nucleic acid as women in low- and middle-income regions. What factors have a significant impact on Shanghai women's choice of self-sampling? 1.4 Study objectives This study was structured to achieve three critical objectives: First, to clinically vali-date a novel cervical self-sampling device through comparative evaluation of high-risk HPV (HR-HPV) genotyping performance against clinician-collected specimens, including sensitivity, specificity, and concordance rate analyses. Second, to systematically assess patient acceptance patterns of self-sampling technology while identifying demographic, socioeconomic, and cultural determinants influencing screening participation rates, thereby generating evidence for protocol optimization. Third, to evaluate the integration potential of self-sampling as a complementary cervical cancer screening modality within China's healthcare system, with specific emphasis on its ability to expand population coverage and reduce geographic disparities in preventive care access. 2. Materials and methods 2.1 Study design This prospective paired-sample study employed a cross-sectional comparative design to assess the diagnostic validity of cervical self-sampling for HPV genotyping. Participants consecutively performed self-collected vaginal sampling followed by immediate physician-obtained cervical specimens, a sequential protocol eliminating potential confounding from prior clinical procedures on vaginal cytological integrity. Using physician-collected specimens as the diagnostic reference standard, self-sampling performance was quantified through sensitivity, specificity, and concordance analyses. A structured questionnaire systematically evaluated participant acceptability profiles of self-sampling technology, perceived procedural comfort levels, and methodological preferences between self-administered and clinician-based approaches. 2.2 Study Site and Participants This cross-sectional study was carried out at the Cervical Specialty Clinic of the Department of Gynecology, Shanghai East Hospital, between September 1, 2024 and February 28, 2025. Participants meeting the following criteria were recruited through convenience sampling: Inclusion criteria :(1) Aged 25-65 years (2) Sexually active (3) Willing to provide written informed consent Exclusion criteria :(1) Sexual intercourse within 24 hours preceding specimen collection (2) Vaginal douching or intravaginal medication use within 3 days prior to sampling (3) Pre-sampling application of acetic acid/iodine solutions (4) Current use of oral contraceptives or vaginal medications (5) Pregnancy status or within 6 weeks postpartum (6) History of cervical resection or total hysterectomy (7) Declined study participation or inability to complete study procedures. 2.3 Sample Size Estimation The sample size was determined using the anticipated concordance (κ=0.95) and 95% confidence interval width (±0.05) from prior research, along with an expected HPV infection rate of 30%. This calculation yielded a required sample of 250 cases. Accounting for a 10% attrition rate, the final recruitment target was set at 275 participants. 2.4 Study Procedures Certified research nurses at Shanghai East Hospital's Cervical Specialty Clinic explained the study protocol and distributed informed consent forms to eligible participants. After obtaining consent, research assistants provided verbal guidance on self-sampling device operation, placed illustrated instructions in the dedicated hospital sampling area, and allowed participants to independently perform self-sampling using provided materials. Attending gynecologists then collected cervical specimens through clinician-administered sampling. All participants completed standardized questionnaires evaluating both sampling methods after specimen collection. (Figure 1) 2.5 Sampling Methods 2.5.1 Self-Sampling Device The study employed a disposable, sterile cervical self-sampler (Batch No.: Xiangmei Note Quarantine 20232181191; Manufacture date: September 2023) produced by Pinjia Health Technology (Hunan) Co., Ltd. Key design features include:（1）Ergonomic structure: Comprising three components - handle, telescoping shaft (14±0.5 cm length), and sampling head (1.5 cm diameter)（2）360° rotating sampling head: Ensures complete cervical contact for adequate cellular material collection（3）Soft silicone material: Minimizes discomfort during self-insertion（4）Anatomical compatibility: Dimensions optimized for vaginal anatomy of Chinese women . The device has been awarded a utility model patent and a design patent in China. (Patent No. ZL 2022 2153373.5; ZL 2023 0862725.7) 2.5.2 Self-sampling procedure The subject should carry out self-sampling in a separate private space, referring to the product instructions: 1. Wash hands and open the product package. 2. In a comfortable position (standing or semi-squatting), hold the handle of the sampler in one hand and gently spread the vulva with the other hand; 3. insert the sampler into the vagina until a slight resistance is felt (usually up to about 14cm); 4. press the button on the end of the sampler to release the tip and rotate the sampler grip for 5-8 weeks (approximately 360° rotation) to ensure full contact with the surface of the cervix; 5. withdraw the tip and gently pull out the sampler when finished; 6. place the sampling head into the supplied cell preservation solution, break or rotate the sampling head away and seal the preservation tube. The entire self-sampling process usually takes 3-5 minutes, and the research assistant is on standby nearby throughout the process, but does not intervene in the actual procedure. 2.5.3 Clinician Sampling Methods Approximately 5 minutes after completion of the self-sampling, the attending gynaecologist (≥5 years of practice) performs the sampling using standard cervical exfoliative cell collection methods. The patient was placed in the cystotomy position, the physician placed a speculum to expose the cervix, and the same type of sampler was used to fully sample the surface of the cervix and the cervical canal, and the sampling head was placed in labelled cytostatic solution for storage. 2.6 Sample Processing and HPV Detection Both self-collected and clinician-collected specimens were preserved in cytological preservation solution (Cida Biotechnology, Guangzhou; Batch No. GZ20230812) at 2–8°C for 24–48 hours. Specimens were subsequently transported at ambient temperature (15–25°C) to Zhengzhou Aiwidi Medical Laboratory (an independent third-party laboratory) with a transit time not exceeding 72 hours. HPV genotyping was performed using a PCR-reverse dot hybridization assay (Human Papillomavirus Genotyping Kit, Type 23; Yaneng Biotechnology, Shenzhen; Batch No. SZ20230915; Registration No. 20173400219). The assay detects 23 HPV subtypes including 18 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82, 83) and 5 low-risk types (6, 11, 42, 43, 44, 81). All specimens were processed within 7 days of laboratory receipt. To minimize inter-batch variability, specimens arriving in the same shipment underwent concurrent analysis. 2.7 Questionnaire Administration Following completion of both sampling methods, subjects completed a structured questionnaire containing five domains: (1) demographic characteristics (age, educational attainment, HPV vaccination history, cervical screening history); (2) procedural experience evaluation using 10-point scales (comfort level: 1=least to 10=most satisfied; pain intensity: 0=no pain to 10=worst pain) for both methods; (3) sampling preference (self-/ clinician-sampling/no preference) with rationale selection (privacy, comfort, professional expertise); (4) self-sampling implementation assessment (operational concerns, assistance requirements); and (5) cost-benefit analysis comparing method preferences under different pricing scenarios (approximately CNY200 for self-sampling versus CNY300 for clinician-sampling). 2.8 Statistical Analysis Statistical analyses adhered to the according-to-protocol principle, including subjects with complete paired HPV test results. Three analytical frameworks were implemented: (1) Concordance Evaluation using Kappa statistics (95% CI; interpretation thresholds: >0.8=very good, 0.61-0.80=good, 0.41-0.60=moderate, 0.21-0.40=fair, <0.21=slight) to quantify inter-method HPV detection agreement; (2) Diagnostic Performance Evaluation calculating self-sampling’s sensitivity, specificity, accuracy, PPV, and NPV (95% CI) against clinician-collected reference standard, with McNemar’s test comparing paired proportions; (3) Acceptability Profiling presenting categorical variables as frequencies (%) and continuous variables as mean±SD/median(IQR), assessing demographic predictors via χ² tests (association strength by Cramér’s V: 0.1-0.3=weak, 0.3-0.5=moderate, >0.5=strong) and identifying self-sampling acceptability determinants through multivariable logistic regression. All analyses were conducted in SPSS 25.0 (IBM Corp.) with α=0.05 defining statistical significance. 3. Results 3.1 Study Population Characteristics As outlined in Fig. 1 , all of 936 women attending the gynecology outpatient clinic at Shanghai East Hospital underwent initial screening. Of these, 658 were excluded due to unmet inclusion criteria or refusal to participate, yielding 278 enrolled participants. During the study period, two participants were excluded for incomplete self-sampling procedures, resulting in 276 cases with full datasets for analysis. Additionally, 268 valid questionnaires were collected, while eight participants completed HPV testing but failed to submit their questionnaires. Table 1 summarizes the cohort’s demographic and clinical profiles. The mean age was 43.6 ± 9.8 years, with the largest proportion (47.8%) aged 31–45 years. HPV vaccination coverage was 35.07%, and 60.45% reported prior HPV testing. Notably, 21.64% had never undergone cervical cancer screening. Table 1 Basic characteristics of the study subjects (N = 268) Characteristics Classification Number Percentage (%) Age (years) 0–30 47 17.5 31–45 128 47.8 46–60 73 27.2 ≥ 61 20 7.5 HPV Vaccination Status Yes 94 35.07 No 171 63.81 Not sure what HPV vaccine is 3 1.12 Previous Cervical Cancer Screening * Pap smear/TCT 120 44.78 HPV testing 162 60.45 Clinician examination (VIA/VILI)/Colposcopy 43 16.04 Not sure if screened 22 8.21 Never screened 58 21.64 Time Since Last HPV Test Within 1 year 81 30.22 Within 3 years 67 25.00 Within 5 years 19 7.09 More than 5 years 14 5.22 Not sure what HPV testing is 17 6.34 Never tested 70 26.12 Location of Previous HPV Testing Hospital 157 58.58 Physical examination center 42 15.67 Self-sampling at home + mail sample + mobile report 1 0.37 Not sure what HPV testing is 6 2.24 Never tested 76 28.36 Other 2 0.75 * Note: Previous Cervical Cancer Screening is multiple choice, with percentages totalling more than 100 per cent. 3.2 Consistency Analysis of HPV Testing As shown in Table 2 , the statistical comparison of HPV test results between self-sampling and clinician sampling revealed a positive concordance rate of 91.4% (95% CI: 83.2–96.5%) and a negative concordance rate of 100% (95% CI: 98.2–100%). The overall concordance (P₀) was 97.5%, with a Kappa coefficient of 0.937 (95% CI: 0.89–0.98), indicating excellent agreement between the two methods. Table 2 Comparison of HPV Test Results (Positive/Negative) between Self-Sampling and Clinician Sampling (N = 276) Positive clinician sampling Negative clinician sampling Total Positive Self-sampling 74(TP) 0(FP) 74 Negative Self-sampling 7(FN) 195(TN) 202 Total 81 195 276 TP: true positive; FP: false positive; FN: false negative; TN: true negative 3.3 Diagnostic Performance Analysis Using clinician sampling results as the gold standard, the diagnostic performance of self-sampling is summarized in Table 3 . Self-sampling demonstrated a sensitivity of 91.4% (95% CI: 83.2–96.5%), specificity of 100% (95% CI: 98.2–100%), accuracy of 97.5% (95% CI: 94.8–99.0%), positive predictive value of 100% (95% CI: 95.1–100%), and negative predictive value of 96.5% (95% CI: 93.0–98.5%). Table 3 Diagnostic Performance Indicators of Self-Sampling Indicator Formula Value(95% CI) Sensitivity TP / (TP + FN) 74 / (74 + 7) = 91.4% (83.2–96.5%) Specificity TN / (TN + FP) 195 / (195 + 0) = 100% (98.2–100%) Accuracy (TP + TN) / Total (74 + 195) / 276 = 97.5% (94.8–99.0%) PPV TP / (TP + FP) 74 / (74 + 0) = 100% (95.0–100%) NPV TN / (TN + FN) 195 / (195 + 7) = 96.5% (93.2–98.5%) Among the seven false-negative HPV test results, further analysis revealed that these cases primarily involved HPV type 58 (three cases), HPV type 16 (two cases), and HPV type 52 (two cases). This suggests potential differences in detection sensitivity across HPV subtypes with self-sampling, or possible contributing factors such as non-adherence to sampling protocols, inadequate sampling depth/volume, or lesion location variability. 3.4 Sampling Method Preference Analysis The results of the questionnaire (N = 268) showed that 41.42% of the respondents preferred cervical self-sampling, 32.09% preferred clinician sampling, and 26.49% indicated that both methods were acceptable. After considering the cost factor (approximately CNY200 for self-sampling vs. approximately CNY 300 for clinician sampling plus time cost), the preference for self-sampling increased significantly to 56.72%, clinician sampling preference decreased to 19.78%, and the indifference rate was 23.51%. This significant change (up 15.3 percentage points) suggests that financial factors are an important consideration influencing the choice of patient sampling method. The main reasons for respondents' preference for self-sampling were: a more comfortable and less embarrassing environment for at-home sampling (59.21%), the ability to control the sampling force by themselves to reduce pain (57.24%), protection of privacy (56.58%), and flexibility and convenience of time (41.45%). These proportions were similar, suggesting that multiple factors combined to influence patients' self-sampling preferences. The main reasons for choosing clinician sampling were that clinician sampling was more professional and reliable (73.58%) and the accuracy of hospital test reports was high (56.60%), while only 9.43 per cent of patients chose clinician sampling because they were afraid to do it by themselves. 3.5 Sampling comfort and pain analysis In terms of comfort rating, 55.97% of the respondents considered self-sampling as more comfortable, only 23.13% considered clinician sampling as more comfortable and 20.90% considered both as equally comfortable. The comfort rating of the self-sampling product showed that 76.87% of the respondents rated it as ‘very satisfactory’ (10 points), while only 49.25% of the physician samplers rated it as ‘very satisfactory’, indicating that the self-sampling has a significant advantage in terms of product comfort (χ²=38.44, P < 0.001). In terms of pain ratings, 67.91% of respondents indicated that self-sampling was less painful, while only 11.94% felt that physician-sampling was less painful, and 20.15% felt that the difference was not significant. Self-sampling pain ratings showed that 71.64% of users rated no pain (0), 21.26% rated mild pain (1–3), and only 7.10% reported moderate or greater pain sensations (4–10). In comparison, clinician sampling was rated as pain-free by only 22.39% of users, 48.13% reported mild pain, and 29.48% reported more than moderate pain sensation. The difference in pain-free rates (71.64% vs. 22.39%) further confirms the clear advantage of self-sampling in mitigating the patient discomfort experience. (Fig. 2 ) 3.6 Analysis of Factors Affecting Sampling Mode Preference Chi-square analysis revealed that sampling mode preference was significantly associated with age, HPV vaccination status, prior screening history, time since last HPV test, subjective comfort during sampling, and self-sampling product comfort/pain scores (P < 0.05, Table 4 ), indicating that preferences are shaped by a combination of individual characteristics, healthcare behaviors, and sampling experiences. Table 4 Analysis of Factors Influencing Preferences in Sampling Methods Variable Self-sampling (%) Clinician sampling (%) Either/No preference (%) χ² P Cramér's V Age Group 29.99 0.00001 0.264 0–30 34.0 29.8 36.2 31–45 31.3 38.3 30.5 46–60 54.8 27.4 17.8 ≥ 61 75.0 15.0 10.0 Vaccination Status 14.29 0.0064 0.163 Vaccinated 26.6 39.4 34.0 Not vaccinated 49.1 28.7 22.2 Screening History 32.61 < 0.0001 0.248 Screened 32.6 39.5 27.9 Unsure 35.0 35.0 30.0 Never screened 72.4 6.9 20.7 Time Since Last HPV Test 29.58 0.0010 0.235 Within 1 year 21.0 50.6 28.4 More than 1 year 44.0 30.0 26.0 Never tested 65.7 14.3 20.0 Comfort Evaluation 194.93 < 0.00001 0.616 Self-sampling more comfortable 70.7 12.7 16.6 Clinician sampling more comfortable 3.2 88.7 8.1 About the same 5.4 21.4 73.2 Self-Sampling Pain Rating 59.28 < 0.00001 0.352 No pain (0) 49.5 26.6 24.0 slight pain (1–3) 22.8 42.1 35.1 moderate-to-severe pain (≥ 4) 10.5 57.9 31.6 Further multifactorial logistic regression analysis identified three independent predictors of self-sampling preference: comfort score (OR = 9.78, 95%CI: 5.12–18.67), age ≥ 46 years (OR = 2.81, 95%CI: 1.43–5.52), and absence of screening history (OR = 3.21, 95%CI: 1.58–6.53). Notably, HPV vaccination history (OR = 0.67, 95%CI: 0.37–1.22) showed no independent association with self-sampling preference. 3.7 Evaluation of Self-Sampling Practices The survey revealed that 91.04% of participants successfully performed cervical self-sampling without challenges and independently adhered to the provided instructions. Among the 8.96% reporting difficulties, operational uncertainties predominated: confusion about swab tip detachment or sample preservation (58.33%), uncertainty regarding sampling adequacy or removal timing (41.67%), ambiguity about insertion depth markers (16.67%), and questions about rotational technique during sampling (16.67%). These results highlight critical gaps in user comprehension, specifically in technical execution and procedural clarity, directly guiding targeted improvements to instructional materials and competency-based training protocols for these operational challenges. 4. Discussion This study demonstrates that cervical self-sampling achieves near-perfect concordance with clinician-collected samples for HPV genotyping (κ = 0.937, 95% CI:0.89–0.98). The molecular analysis revealed equivalent diagnostic performance between methods: 91.4% sensitivity (detecting true positives) and 100% specificity (excluding false positives), with an overall accuracy of 97.5%. Notably, both modalities showed identical positive predictive values (100%), while the negative predictive value of self-sampling reached 96.5%. Critically, no statistically significant difference emerged in high-risk HPV detection rates between self- and clinician-sampling, robustly validating self-sampling as a reliable alternative for HPV genetic testing in cervical cancer screening programs. The acceptability analysis revealed tiered preference for self-sampling, with 41.42% of participants expressing immediate preference that increased to 56.72% when cost considerations were introduced. Three patient-centered factors emerged as key drivers for choosing self-sampling: comfort (59.21%), privacy protection (56.58%), and reduced pain perception (57.24%). These findings align with a large-scale validation study (N = 8,136) in China's remote regions [ 25 ], where self-sampling acceptance reached 62.37%, with convenience (32.66%), privacy (21.84%), and pain reduction (21.18%) serving as comparable motivators; proportional differences between studies are attributable to distinct questionnaire designs (single- vs. multiple-choice formats). The highest acceptance rate (72.4%) was observed among cervical cancer screening-naïve women, underscoring self-sampling's potential to bridge screening gaps in historically underserved populations. This evidence base supports targeted deployment of direct-mail self-sampling kits to priority groups, including due/overdue screeners and non-adherent populations, where this modality demonstrates enhanced screening efficacy [ 26 ]. Furthermore, self-sampling addresses critical healthcare challenges by facilitating HPV testing implementation in resource-limited settings lacking routine screening infrastructure while simultaneously providing a viable alternative for maintaining cervical cancer screening continuity during public health emergencies such as the COVID-19 pandemic [ 27 , 28 ]. Notably, a Dutch population-based study (n = 840,428) revealed critical challenges in self-sampling implementation: clinician-collected specimens demonstrated superior follow-up adherence, as HR-HPV-positive women using self-sampling faced significantly elevated risks of triage non-compliance (OR = 3.87, 95%CI 3.55–4.23), colposcopy attrition, and loss-to-follow-up compared to physician-sampled counterparts [ 29 ]. These findings highlight the imperative of implementing a tripartite strategy: (1) rigorous tracking systems for self-sampling positives, (2) enhanced patient health literacy programs to address follow-up barriers, and (3) development of streamlined triage protocols requiring fewer clinical visits. Such measures are essential to mitigate downstream attrition risks that currently undermine program efficacy while preserving self-sampling's coverage advantages. 4.2 Methodological and Clinical Strengths Three key methodological strengths distinguish this investigation. First, the prospective matched-pair design enabled direct intra-individual comparison between self-collected and clinician-obtained specimens, effectively eliminating confounding from inter-subject variability through sequential dual sampling. Second, we systematically mapped the associations between critical demographic determinants (age, screening history) and sampling modality preferences, generating actionable evidence for stratified implementation strategies. Third, the study employed a novel self-sampling device ergonomically optimized to accommodate the anatomical characteristics of Chinese women's cervical canals, a technical refinement that may enhance sampling adequacy compared to conventional designs. Guided by established evidence showing higher self-sampling acceptance among urban residents and individuals with advanced education [ 30 ], we strategically selected a Shanghai-based cohort to simultaneously evaluate diagnostic performance (via histopathological confirmation) and user acceptability metrics (through structured questionnaires). This dual assessment framework not only validated the device's clinical reliability but also quantified its social receptivity in a population with concentrated healthcare resources, thereby providing a comprehensive evidence base for scaling self-sampling programs in metropolitan settings. 4.3 Limitations This study has several limitations that warrant careful consideration. The statistical robustness may be constrained by the moderate sample size (N = 276), particularly in subgroup analyses. Conducted at a single medical center with predominantly urban participants, the findings may lack generalizability to rural and remote populations, thereby inadequately reflecting China's diverse demographic landscape. Furthermore, the self-sampling procedure was administered under researcher supervision rather than in unsupervised home environments, potentially overestimating accuracy in real-world implementation. The cross-sectional design also precludes assessment of long-term outcomes, including the sustained impact of self-sampling on CIN2 + detection rates and cervical cancer incidence reduction. Additionally, the cost-related questions in the survey relied on hypothetical payment scenarios rather than actual financial decisions, which may inflate willingness-to-pay estimates. Future research should incorporate revealed-preference experiments with tiered pricing models for self-sampling kits to quantify price elasticity. Multilevel analyses are needed to examine geographic disparities in cost sensitivity (e.g., high-income vs. low-income regions) and evaluate insurance reimbursement frameworks (e.g., integration with public healthcare or commercial insurance coverage). Such investigations could identify economic thresholds to enhance affordability and expand HPV screening coverage, particularly through policy innovations that subsidize self-sampling costs or integrate home-based testing into national prevention programs. 4.4 Clinical and Public Health Implications This study provides empirical support for integrating cervical self-sampling as a complementary strategy to clinician-collected sampling, particularly in populations with suboptimal screening coverage. The inherent advantages of self-sampling—enhanced accessibility, privacy protection, and reduced procedural discomfort—position it as a viable intervention to improve HPV screening adherence. A key finding reveals the critical role of cost differentials in modality selection: when self-sampling was priced at 200 CNY compared to 300 CNY (plus time costs) for clinic-based sampling, preference rates increased by 15.3 percentage points. This finding suggests that even in economically developed regions, price factors can influence respondents' choices. Of course, respondents in economically developed regions place greater emphasis on the opportunity cost of lost time than those in middle- and low-income regions. Therefore, through reasonable pricing strategies and medical insurance policy support, coupled with improvements in the efficiency of medical visits, self-sampling is expected to achieve broader coverage. Three implementation pathways warrant prioritization: First, hospital-based distribution of self-sampling kits with postal return systems could decentralize screening access. Second, community health centers could operationalize standardized training protocols to ensure procedural competency. Third, mobile health platforms should be leveraged to provide real-time instructional support, particularly in resource-limited settings. Tailored communication strategies are equally vital—emphasizing privacy and convenience for younger demographics, while highlighting simplified protocols and minimal discomfort for older populations. Such multidimensional approaches could catalyze the integration of self-sampling into national cervical cancer prevention programs, ultimately advancing health equity across socioeconomic strata. 4.5 Future Research Directions Building upon current evidence, five research priorities emerge requiring systematic investigation. First, large-scale multicenter validation studies should expand sample sizes across diverse geographic regions and demographic subgroups, particularly addressing variations by age, education level, and urban/rural residency to strengthen generalizability. Second, real-world accuracy assessments must evaluate self-sampling performance in unsupervised home environments, with dedicated focus on operational errors among populations with differing educational backgrounds. Third, the development of digital assistance tools warrants urgent attention, including mobile app-guided video tutorials for standardized sampling procedures and AI-driven quality control systems to overcome challenges in sample preservation and adequacy evaluation. Fourth, longitudinal clinical impact studies through sustained follow-up are needed to establish self-sampling's effectiveness in precancerous lesion detection and early cervical cancer diagnosis. Finally, comprehensive cost-benefit analyses comparing self-sampling with clinic-based methods should quantify direct medical costs, time expenditures, and systemic healthcare burdens. 5. Conclusions This study demonstrates that the novel cervical self-sampling device achieves high diagnostic performance for HPV genotyping, with 91.4% sensitivity and 100% specificity, showing near-perfect concordance with physician-collected samples (κ=0.937). Notably, over half of participants (56.72%) preferred self-sampling after cost considerations, with 71.64% reporting pain-free experiences compared to 22.39% in clinician-assisted sampling, underscoring its advantages in comfort and tolerability. Demographic analysis revealed stronger preference among individuals aged ≥46 years, those without prior screening history, and participants perceiving enhanced procedural comfort. In addition, even patients in economically developed regions are more likely to accept self-sampling testing due to price factors and time costs. While cervical self-sampling serves as a practical complement to clinician-based methods and holds potential to expand screening coverage-particularly for underscreened populations—its clinical implementation requires addressing operational training needs and inter-genotype detection sensitivity variations. As technological refinements and practical experience accumulate, this approach is positioned to become a pivotal tool in China's cervical cancer prevention strategy, bridging gaps in early detection accessibility. Declarations CRediT authorship contribution statement Bowen Xu : Conceptualization; Investigation; Methodology; Writing - original draft. Jingjing Liu : Data curation; Formal analysis. Hui Li : Data curation; Investigation. Tingting Zhang : Supervision; Validation; Writing - review & editing. Fang Li : Project administration; Resources. Ethics approval This study received ethical clearance from the Institutional Review Board of Shanghai East Hospital (Ethical Review Number: 2024YS-182; Approval Date: 15 August 2024) and was prospectively registered with the Chinese Clinical Trial Registry (Registration ID: ChiCTR2500100121). All participants signed a written informed consent form. Funding This study was supported by the Pudong New Area ‘National Experimental Zone for Comprehensive Reform of Chinese Medicine Development’ Construction Project（PDZY-2023-1104）;The National Natural Science Foundation of China (NSFC; 82273091). Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Acknowledgments The authors acknowledge Mrs Wenjuan Ji，the staff of Shanghai SanteFam Healthcare Technology Co., Ltd. for hers assistance in participant training. References Bray, F., et al., Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 2024. 74(3): p. 229-263. WHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: Use of dual-stain cytology to triage women after a positive test for human papillomavirus (HPV). WHO Guidelines Approved by the Guidelines Review Committee. 2024, Geneva: World Health Organization. Han, B., et al., Cancer incidence and mortality in China, 2022. Journal of the National Cancer Center, 2024. 4(1): p. 47-53. Crosbie, E.J., et al., Human papillomavirus and cervical cancer. Lancet, 2013. 382(9895): p. 889-99. Schiffman, M. and N. Wentzensen, Human Papillomavirus Infection and the Multistage Carcinogenesis of Cervical Cancer. Cancer Epidemiology, Biomarkers & Prevention, 2013. 22(4): p. 553-560. Bertoli, H.K., et al., Risk of vulvar, vaginal and anal high-grade intraepithelial neoplasia and cancer according to cervical human papillomavirus (HPV) status: A population-based prospective cohort study. Gynecologic Oncology, 2020. 157(2): p. 456-462. Chen, G., et al., Prevalence and genotype distribution of human papillomavirus in women with cervical cancer or cervical intraepithelial neoplasia in Henan province, central China. Journal of Medical Virology, 2020. 92(12): p. 3743-3749. Wei, F., et al., Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. The Lancet (British edition), 2024. 404(10451): p. 435-444. Cuzick, J., et al., Overview of Human Papillomavirus-Based and Other Novel Options for Cervical Cancer Screening in Developed and Developing Countries. Vaccine, 2008. 26: p. K29-K41. Wright, T.C., et al., Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test. Gynecologic Oncology, 2015. 136(2): p. 189-197. Li MZ, et al. Chinese Guidelines for Cervical Cancer Screening (I). Modern Advances in Obstetrics and Gynecology. 2023;32(7):481-487. Borek, A.J., et al., Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users’ views. BMC Public Health, 2025. 25(1). Gravitt, P.E., et al., Looking ahead: A case for human papillomavirus testing of self‐sampled vaginal specimens as a cervical cancer screening strategy. International Journal of Cancer, 2011. 129(3): p. 517-527. Hillemanns, P., et al., Screening for cervical neoplasia by self-assessment for human papillomavirus DNA. The Lancet (British edition), 1999. 354(9194): p. 1970-1970. Tatara, T., et al., The Influence of Vaginal HPV Self-Sampling on the Efficacy of Populational Screening for Cervical Cancer—An Umbrella Review. Cancers, 2022. 14(23): p. 5913. Yeh, P.T., et al., Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis. BMJ Global Health, 2019. 4(3): p. e001351. Styffe, C., et al., HPV Self-sampling in Indigenous Communities: A Scoping Review. Journal of Immigrant and Minority Health, 2020. 22(4): p. 852-859. Mezei, A.K., et al., Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review. International Journal of Cancer, 2017. 141(3): p. 437-446. Malone, C., et al., Cost-effectiveness studies of HPV self-sampling: A systematic review. Preventive Medicine, 2020. 132: p. 105953. Atkinson, A.E., et al., Screening for Human Papillomavirus in a Low- and Middle-Income Country. Journal of global oncology, 2019. 5(5): p. JGO1800233-JGO1800233. Campos, N.G., et al., Cervical cancer screening in low‐resource settings: A cost‐effectiveness framework for valuing tradeoffs between test performance and program coverage. International Journal of Cancer, 2015. 137(9): p. 2208-2219. Parapob, N., et al., A comparative study of self-collected versus clinician-collected specimens in detecting high-risk HPV infection: a prospective cross-sectional study. Obstetrics & Gynecology Science, 2024. 67(6): p. 557-564. WHO, World Health Organization (WHO). Self‐care interventions: human papillomavirus (HPV) self‐sampling as part of cervical cancer screening and treatment, 2022 update. 2023. Serrano, B., et al., Worldwide use of HPV self-sampling for cervical cancer screening. Preventive Medicine, 2022. 154: p. 106900. Li, J., et al., Effectiveness and feasibility of self-sampling for human papillomavirus testing for internet-based cervical cancer screening. Frontiers in Public Health, 2022. 10. Winer, R.L., et al., Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits. JAMA, 2023. 330(20): p. 1971. Parker, S., et al., Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Elife, 2023. 12. Ajenifuja, K.O., et al., Designing low-cost, accurate cervical screening strategies that take into account COVID-19: a role for self-sampled HPV typing. Infectious Agents and Cancer, 2020. 15(1). Olthof, E.M.G., et al., The impact of loss to follow‐up in the Dutch organised HPV‐based cervical cancer screening programme. International Journal of Cancer, 2024. 154(12): p. 2132-2141. Shao, J., et al., Knowledge, attitudes, and practices of human papillomavirus and self-sampling among adult women: a cross-sectional study. Frontiers in Public Health, 2024. 12. Additional Declarations No competing interests reported. Supplementary Files Cervicalselfsampler.jpg Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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2","display":"","copyAsset":false,"role":"figure","size":92694,"visible":true,"origin":"","legend":"\u003cp\u003eSelf-Sampling \u0026amp; Clinician Sampling Pain Ratings (Scale 0–10, with 0 being “No Pain”)\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7693739/v1/27c5519fbe3a282057744753.png"},{"id":95527044,"identity":"28d682d4-e07d-4773-877c-ea6098899112","added_by":"auto","created_at":"2025-11-10 10:09:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1459340,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7693739/v1/eee3db88-859b-44de-b701-3f48f364d35c.pdf"},{"id":93240852,"identity":"f421e262-fdca-44c8-b5e0-6be654187368","added_by":"auto","created_at":"2025-10-10 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Introduction","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e\u003ch2\u003e1.1 Pathogenic association between HPV infection and cervical cancer\u003c/h2\u003e\u003cp\u003eCervical cancer, the fourth most prevalent malignancy and fourth leading cause of cancer-related mortality in women worldwide [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e], poses a significant threat to global women's health. The World Health Organization (WHO) estimates 604,000 new cases and 349,000 deaths globally in 2022, with cervical cancer ranking as the most frequent female malignancy in 25 countries [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In China, 2022 cancer registry data from the National Cancer Center reported 150,700 new cervical cancer cases among 4,824,700 total cancer diagnoses [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e\u003cp\u003ePersistent infection with high-risk human papillomavirus (HR-HPV) genotypes (particularly HPV 16/18) is the primary etiological factor for cervical carcinogenesis. These oncogenic variants induce dysregulation of cervical epithelial cell cycle control mechanisms, ultimately leading to malignant transformation [\u003cspan additionalcitationids=\"CR5\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Notably, HPV 16/18 account for 70% of cervical cancer cases globally, while regional data from Henan Province, China, reveals a 75.7% detection rate of HPV 16/58/52 among cervical cancer patients [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The disproportionately higher mortality rates in developing countries, attributable to limited screening resources, underscore the critical role of HPV-based screening in cervical cancer prevention [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e1.2 Clinical value of HPV testing in cervical cancer early detection\u003c/h2\u003e\u003cp\u003eHPV genotyping has emerged as a cornerstone of cervical cancer screening, demonstrating superior sensitivity and negative predictive value compared to conventional cytological methods such as Pap smears [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. This molecular approach enables earlier detection of high-risk HPV infections, thereby facilitating timely interventions to reduce cervical cancer incidence and mortality. Furthermore, HPV genotyping provides critical information for risk stratification through specific high-risk genotype identification, supporting personalized clinical management and surveillance protocols [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn January 2023, China's National Health Commission launched the Accelerating Cervical Cancer Elimination Action Plan (2023\u0026ndash;2030), mandating nationwide improvements in cervical cancer prevention systems and comprehensive treatment capabilities. Concurrently, the Chinese Guidelines for Cervical Cancer Screening (I) (2023) established HR-HPV nucleic acid testing as the primary screening modality [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Despite these advancements, current HR-HPV screening implementation in China remains suboptimal, with significant regional disparities in coverage rates. These challenges primarily stem from limited healthcare accessibility and variable patient acceptance of screening procedures.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e1.3 Clinical implications and implementation challenges of cervical self-sampling\u003c/h2\u003e\u003cp\u003eSelf-sampling for rapid testing has gained global traction in medical diagnostics, particularly during the COVID-19 pandemic [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Conventional cervical screening methods relying on clinician-collected Pap smears or HPV tests face limitations due to healthcare resource disparities and women's concerns regarding privacy and procedural discomfort, resulting in persistently low screening coverage in underserved regions [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The clinical utility of HPV self-sampling was first demonstrated in 1999 by Hillemanns et al., who reported 93% sensitivity for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) lesions [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eGlobal implementation studies confirm that HPV self-sampling significantly enhances screening accessibility through decentralized specimen collection. Systematic reviews demonstrate that home-based self-sampling programs achieve screening participation rates several-fold higher than traditional clinic-based approaches [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. This strategy has proven particularly effective in hard-to-reach populations, such as Canada's Indigenous communities, where its convenience and privacy advantages overcome cultural barriers to screening participation [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Economic analyses further highlight the cost-effectiveness of self-sampling, prompting large-scale validation studies across low- and middle-income countries (LMICs) in the Americas, Asia, and Africa [\u003cspan additionalcitationids=\"CR19 CR20 CR21\" citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. Recognizing its transformative potential, the World Health Organization (WHO) now endorses self-sampling as a cornerstone strategy for cervical cancer elimination in LMICs [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite these advancements, global adoption remains limited. A 2023 landscape analysis revealed that only 35% of 139 countries with formal screening guidelines promote HPV primary screening, with merely 17 nations (35% of HPV-adopting countries) officially recommending self-sampling [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. In China, persistent challenges include suboptimal HR-HPV screening rates and pronounced regional disparities in implementation. The integration of self-sampling for HR-HPV nucleic acid detection could address these gaps by leveraging its operational simplicity and privacy protection features, thereby expanding screening coverage and advancing national cervical cancer prevention objectives. We are more interested in understanding whether women in economically developed regions of China, such as Shanghai, where medical conditions are advanced, have the same level of acceptance for self-sampling testing for high-risk HPV nucleic acid as women in low- and middle-income regions. What factors have a significant impact on Shanghai women's choice of self-sampling?\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e1.4 Study objectives\u003c/h2\u003e\u003cp\u003eThis study was structured to achieve three critical objectives: First, to clinically vali-date a novel cervical self-sampling device through comparative evaluation of high-risk HPV (HR-HPV) genotyping performance against clinician-collected specimens, including sensitivity, specificity, and concordance rate analyses. Second, to systematically assess patient acceptance patterns of self-sampling technology while identifying demographic, socioeconomic, and cultural determinants influencing screening participation rates, thereby generating evidence for protocol optimization. Third, to evaluate the integration potential of self-sampling as a complementary cervical cancer screening modality within China's healthcare system, with specific emphasis on its ability to expand population coverage and reduce geographic disparities in preventive care access.\u003c/p\u003e\u003c/div\u003e"},{"header":"2. Materials and methods","content":"\u003cp\u003e\u003cstrong\u003e2.1 Study design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis prospective paired-sample study employed a cross-sectional comparative design to assess the diagnostic validity of cervical self-sampling for HPV genotyping. Participants consecutively performed self-collected vaginal sampling followed by immediate physician-obtained cervical specimens, a sequential protocol eliminating potential confounding from prior clinical procedures on vaginal cytological integrity. Using physician-collected specimens as the diagnostic reference standard, self-sampling performance was quantified through sensitivity, specificity, and concordance analyses. A structured questionnaire systematically evaluated participant acceptability profiles of self-sampling technology, perceived procedural comfort levels, and methodological preferences between self-administered and clinician-based approaches.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2 Study Site and Participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis cross-sectional study was carried out at the Cervical Specialty Clinic of the Department of Gynecology, Shanghai East Hospital, between September 1, 2024 and February 28, 2025. Participants meeting the following criteria were recruited through convenience sampling:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInclusion criteria\u003c/strong\u003e:(1) Aged 25-65 years (2) Sexually active (3) Willing to provide written informed consent\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExclusion criteria\u003c/strong\u003e:(1) Sexual intercourse within 24 hours preceding specimen collection (2) Vaginal douching or intravaginal medication use within 3 days prior to sampling (3) Pre-sampling application of acetic acid/iodine solutions (4) Current use of oral contraceptives or vaginal medications (5) Pregnancy status or within 6 weeks postpartum (6) History of cervical resection or total hysterectomy (7) Declined study participation or inability to complete study procedures.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3 Sample Size Estimation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size was determined using the anticipated concordance (κ=0.95) and 95% confidence interval width (±0.05) from prior research, along with an expected HPV infection rate of 30%. This calculation yielded a required sample of 250 cases. Accounting for a 10% attrition rate, the final recruitment target was set at 275 participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.4 Study Procedures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCertified research nurses at Shanghai East Hospital's Cervical Specialty Clinic explained the study protocol and distributed informed consent forms to eligible participants. After obtaining consent, research assistants provided verbal guidance on self-sampling device operation, placed illustrated instructions in the dedicated hospital sampling area, and allowed participants to independently perform self-sampling using provided materials. Attending gynecologists then collected cervical specimens through clinician-administered sampling. All participants completed standardized questionnaires evaluating both sampling methods after specimen collection. (Figure 1)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5 Sampling Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.1 Self-Sampling Device\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study employed a disposable, sterile cervical self-sampler (Batch No.: Xiangmei Note Quarantine 20232181191; Manufacture date: September 2023) produced by Pinjia Health Technology (Hunan) Co., Ltd. Key design features include:（1）Ergonomic structure: Comprising three components - handle, telescoping shaft (14±0.5 cm length), and sampling head (1.5 cm diameter)（2）360° rotating sampling head: Ensures complete cervical contact for adequate cellular material collection（3）Soft silicone material: Minimizes discomfort during self-insertion（4）Anatomical compatibility: Dimensions optimized for vaginal anatomy of Chinese women .\u003c/p\u003e\n\u003cp\u003eThe device has been awarded a utility model patent and a design patent in China. (Patent No. ZL 2022 2153373.5; ZL 2023 0862725.7)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.2 Self-sampling procedure\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe subject should carry out self-sampling in a separate private space, referring to the product instructions:\u003c/p\u003e\n\u003cp\u003e1. Wash hands and open the product package.\u003c/p\u003e\n\u003cp\u003e2. In a comfortable position (standing or semi-squatting), hold the handle of the sampler in one hand and gently spread the vulva with the other hand;\u003c/p\u003e\n\u003cp\u003e3. insert the sampler into the vagina until a slight resistance is felt (usually up to about 14cm);\u003c/p\u003e\n\u003cp\u003e4. press the button on the end of the sampler to release the tip and rotate the sampler grip for 5-8 weeks (approximately 360° rotation) to ensure full contact with the surface of the cervix;\u003c/p\u003e\n\u003cp\u003e5. withdraw the tip and gently pull out the sampler when finished;\u003c/p\u003e\n\u003cp\u003e6. place the sampling head into the supplied cell preservation solution, break or rotate the sampling head away and seal the preservation tube.\u003c/p\u003e\n\u003cp\u003eThe entire self-sampling process usually takes 3-5 minutes, and the research assistant is on standby nearby throughout the process, but does not intervene in the actual procedure.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5.3 Clinician Sampling Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eApproximately 5 minutes after completion of the self-sampling, the attending gynaecologist (≥5 years of practice) performs the sampling using standard cervical exfoliative cell collection methods. The patient was placed in the cystotomy position, the physician placed a speculum to expose the cervix, and the same type of sampler was used to fully sample the surface of the cervix and the cervical canal, and the sampling head was placed in labelled cytostatic solution for storage.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.6 Sample Processing and HPV Detection\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth self-collected and clinician-collected specimens were preserved in cytological preservation solution (Cida Biotechnology, Guangzhou; Batch No. GZ20230812) at 2–8°C for 24–48 hours. Specimens were subsequently transported at ambient temperature (15–25°C) to Zhengzhou Aiwidi Medical Laboratory (an independent third-party laboratory) with a transit time not exceeding 72 hours.\u003c/p\u003e\n\u003cp\u003eHPV genotyping was performed using a PCR-reverse dot hybridization assay (Human Papillomavirus Genotyping Kit, Type 23; Yaneng Biotechnology, Shenzhen; Batch No. SZ20230915; Registration No. 20173400219). The assay detects 23 HPV subtypes including 18 high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 73, 82, 83) and 5 low-risk types (6, 11, 42, 43, 44, 81). All specimens were processed within 7 days of laboratory receipt. To minimize inter-batch variability, specimens arriving in the same shipment underwent concurrent analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.7 Questionnaire Administration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFollowing completion of both sampling methods, subjects completed a structured questionnaire containing five domains: (1) demographic characteristics (age, educational attainment, HPV vaccination history, cervical screening history); (2) procedural experience evaluation using 10-point scales (comfort level: 1=least to 10=most satisfied; pain intensity: 0=no pain to 10=worst pain) for both methods; (3) sampling preference (self-/ clinician-sampling/no preference) with rationale selection (privacy, comfort, professional expertise); (4) self-sampling implementation assessment (operational concerns, assistance requirements); and (5) cost-benefit analysis comparing method preferences under different pricing scenarios (approximately CNY200 for self-sampling versus CNY300 for clinician-sampling).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8 Statistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analyses adhered to the according-to-protocol principle, including subjects with complete paired HPV test results. Three analytical frameworks were implemented: (1) Concordance Evaluation using Kappa statistics (95% CI; interpretation thresholds: \u0026gt;0.8=very good, 0.61-0.80=good, 0.41-0.60=moderate, 0.21-0.40=fair, \u0026lt;0.21=slight) to quantify inter-method HPV detection agreement; (2) Diagnostic Performance Evaluation calculating self-sampling’s sensitivity, specificity, accuracy, PPV, and NPV (95% CI) against clinician-collected reference standard, with McNemar’s test comparing paired proportions; (3) Acceptability Profiling presenting categorical variables as frequencies (%) and continuous variables as mean±SD/median(IQR), assessing demographic predictors via χ² tests (association strength by Cramér’s V: 0.1-0.3=weak, 0.3-0.5=moderate, \u0026gt;0.5=strong) and identifying self-sampling acceptability determinants through multivariable logistic regression. All analyses were conducted in SPSS 25.0 (IBM Corp.) with α=0.05 defining statistical significance.\u003c/p\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Study Population Characteristics\u003c/h2\u003e\u003cp\u003eAs outlined in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e, all of 936 women attending the gynecology outpatient clinic at Shanghai East Hospital underwent initial screening. Of these, 658 were excluded due to unmet inclusion criteria or refusal to participate, yielding 278 enrolled participants. During the study period, two participants were excluded for incomplete self-sampling procedures, resulting in 276 cases with full datasets for analysis. Additionally, 268 valid questionnaires were collected, while eight participants completed HPV testing but failed to submit their questionnaires.\u003c/p\u003e\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e summarizes the cohort\u0026rsquo;s demographic and clinical profiles. The mean age was 43.6\u0026thinsp;\u0026plusmn;\u0026thinsp;9.8 years, with the largest proportion (47.8%) aged 31\u0026ndash;45 years. HPV vaccination coverage was 35.07%, and 60.45% reported prior HPV testing. Notably, 21.64% had never undergone cervical cancer screening.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eBasic characteristics of the study subjects (N\u0026thinsp;=\u0026thinsp;268)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristics\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eClassification\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNumber\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ePercentage (%)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e0\u0026ndash;30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e17.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e31\u0026ndash;45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e128\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e47.8\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e46\u0026ndash;60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e73\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e27.2\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e7.5\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHPV Vaccination Status\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eYes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e94\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e35.07\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNo\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e171\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e63.81\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot sure what HPV vaccine is\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e1.12\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003ePrevious Cervical Cancer Screening *\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePap smear/TCT\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e120\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e44.78\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHPV testing\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e162\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e60.45\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eClinician examination (VIA/VILI)/Colposcopy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e43\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e16.04\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot sure if screened\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e8.21\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNever screened\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e21.64\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime Since Last HPV Test\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWithin 1 year\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e30.22\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWithin 3 years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e25.00\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eWithin 5 years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e19\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e7.09\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eMore than 5 years\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e14\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e5.22\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot sure what HPV testing is\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e6.34\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNever tested\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e70\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e26.12\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eLocation of Previous HPV Testing\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eHospital\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e157\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e58.58\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePhysical examination center\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e42\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e15.67\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSelf-sampling at home\u0026thinsp;+\u0026thinsp;mail sample\u0026thinsp;+\u0026thinsp;mobile report\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.37\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNot sure what HPV testing is\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2.24\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eNever tested\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e76\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e28.36\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOther\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.75\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003e* Note: Previous Cervical Cancer Screening is multiple choice, with percentages totalling more than 100 per cent.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec20\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Consistency Analysis of HPV Testing\u003c/h2\u003e\u003cp\u003eAs shown in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e, the statistical comparison of HPV test results between self-sampling and clinician sampling revealed a positive concordance rate of 91.4% (95% CI: 83.2\u0026ndash;96.5%) and a negative concordance rate of 100% (95% CI: 98.2\u0026ndash;100%). The overall concordance (P₀) was 97.5%, with a Kappa coefficient of 0.937 (95% CI: 0.89\u0026ndash;0.98), indicating excellent agreement between the two methods.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eComparison of HPV Test Results (Positive/Negative) between Self-Sampling and Clinician Sampling (N\u0026thinsp;=\u0026thinsp;276)\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePositive clinician sampling\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eNegative clinician sampling\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eTotal\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePositive Self-sampling\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e74(TP)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e0(FP)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e74\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eNegative Self-sampling\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e7(FN)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e195(TN)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e202\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e195\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e276\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"4\"\u003eTP: true positive; FP: false positive; FN: false negative; TN: true negative\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Diagnostic Performance Analysis\u003c/h2\u003e\u003cp\u003eUsing clinician sampling results as the gold standard, the diagnostic performance of self-sampling is summarized in Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e. Self-sampling demonstrated a sensitivity of 91.4% (95% CI: 83.2\u0026ndash;96.5%), specificity of 100% (95% CI: 98.2\u0026ndash;100%), accuracy of 97.5% (95% CI: 94.8\u0026ndash;99.0%), positive predictive value of 100% (95% CI: 95.1\u0026ndash;100%), and negative predictive value of 96.5% (95% CI: 93.0\u0026ndash;98.5%).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eDiagnostic Performance Indicators of Self-Sampling\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\"+\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eIndicator\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eFormula\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eValue(95% CI)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eSensitivity\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTP / (TP\u0026thinsp;+\u0026thinsp;FN)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"+\" colname=\"c3\"\u003e\u003cp\u003e74 / (74\u0026thinsp;+\u0026thinsp;7) =\u0026nbsp;\u003cb\u003e91.4%\u003c/b\u003e\u0026nbsp;(83.2\u0026ndash;96.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eSpecificity\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTN / (TN\u0026thinsp;+\u0026thinsp;FP)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"+\" colname=\"c3\"\u003e\u003cp\u003e195 / (195\u0026thinsp;+\u0026thinsp;0) =\u0026nbsp;\u003cb\u003e100%\u003c/b\u003e\u0026nbsp;(98.2\u0026ndash;100%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAccuracy\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e(TP\u0026thinsp;+\u0026thinsp;TN) / Total\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"+\" colname=\"c3\"\u003e\u003cp\u003e(74\u0026thinsp;+\u0026thinsp;195) / 276 =\u0026nbsp;\u003cb\u003e97.5%\u003c/b\u003e\u0026nbsp;(94.8\u0026ndash;99.0%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003ePPV\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTP / (TP\u0026thinsp;+\u0026thinsp;FP)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"+\" colname=\"c3\"\u003e\u003cp\u003e74 / (74\u0026thinsp;+\u0026thinsp;0) =\u0026nbsp;\u003cb\u003e100%\u003c/b\u003e\u0026nbsp;(95.0\u0026ndash;100%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eNPV\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eTN / (TN\u0026thinsp;+\u0026thinsp;FN)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\"+\" colname=\"c3\"\u003e\u003cp\u003e195 / (195\u0026thinsp;+\u0026thinsp;7) =\u0026nbsp;\u003cb\u003e96.5%\u003c/b\u003e\u0026nbsp;(93.2\u0026ndash;98.5%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eAmong the seven false-negative HPV test results, further analysis revealed that these cases primarily involved HPV type 58 (three cases), HPV type 16 (two cases), and HPV type 52 (two cases). This suggests potential differences in detection sensitivity across HPV subtypes with self-sampling, or possible contributing factors such as non-adherence to sampling protocols, inadequate sampling depth/volume, or lesion location variability.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\u003ch2\u003e3.4 Sampling Method Preference Analysis\u003c/h2\u003e\u003cp\u003eThe results of the questionnaire (N\u0026thinsp;=\u0026thinsp;268) showed that 41.42% of the respondents preferred cervical self-sampling, 32.09% preferred clinician sampling, and 26.49% indicated that both methods were acceptable. After considering the cost factor (approximately CNY200 for self-sampling vs. approximately CNY 300 for clinician sampling plus time cost), the preference for self-sampling increased significantly to 56.72%, clinician sampling preference decreased to 19.78%, and the indifference rate was 23.51%. This significant change (up 15.3 percentage points) suggests that financial factors are an important consideration influencing the choice of patient sampling method.\u003c/p\u003e\u003cp\u003eThe main reasons for respondents' preference for self-sampling were: a more comfortable and less embarrassing environment for at-home sampling (59.21%), the ability to control the sampling force by themselves to reduce pain (57.24%), protection of privacy (56.58%), and flexibility and convenience of time (41.45%). These proportions were similar, suggesting that multiple factors combined to influence patients' self-sampling preferences. The main reasons for choosing clinician sampling were that clinician sampling was more professional and reliable (73.58%) and the accuracy of hospital test reports was high (56.60%), while only 9.43 per cent of patients chose clinician sampling because they were afraid to do it by themselves.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec23\" class=\"Section2\"\u003e\u003ch2\u003e3.5 Sampling comfort and pain analysis\u003c/h2\u003e\u003cp\u003eIn terms of comfort rating, 55.97% of the respondents considered self-sampling as more comfortable, only 23.13% considered clinician sampling as more comfortable and 20.90% considered both as equally comfortable. The comfort rating of the self-sampling product showed that 76.87% of the respondents rated it as \u0026lsquo;very satisfactory\u0026rsquo; (10 points), while only 49.25% of the physician samplers rated it as \u0026lsquo;very satisfactory\u0026rsquo;, indicating that the self-sampling has a significant advantage in terms of product comfort (χ\u0026sup2;=38.44, P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003cp\u003eIn terms of pain ratings, 67.91% of respondents indicated that self-sampling was less painful, while only 11.94% felt that physician-sampling was less painful, and 20.15% felt that the difference was not significant.\u003c/p\u003e\u003cp\u003eSelf-sampling pain ratings showed that 71.64% of users rated no pain (0), 21.26% rated mild pain (1\u0026ndash;3), and only 7.10% reported moderate or greater pain sensations (4\u0026ndash;10). In comparison, clinician sampling was rated as pain-free by only 22.39% of users, 48.13% reported mild pain, and 29.48% reported more than moderate pain sensation. The difference in pain-free rates (71.64% vs. 22.39%) further confirms the clear advantage of self-sampling in mitigating the patient discomfort experience. (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e)\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec24\" class=\"Section2\"\u003e\u003ch2\u003e3.6 Analysis of Factors Affecting Sampling Mode Preference\u003c/h2\u003e\u003cp\u003eChi-square analysis revealed that sampling mode preference was significantly associated with age, HPV vaccination status, prior screening history, time since last HPV test, subjective comfort during sampling, and self-sampling product comfort/pain scores (P\u0026thinsp;\u0026lt;\u0026thinsp;0.05, Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e), indicating that preferences are shaped by a combination of individual characteristics, healthcare behaviors, and sampling experiences.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eAnalysis of Factors Influencing Preferences in Sampling Methods\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"7\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVariable\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eSelf-sampling (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eClinician sampling (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eEither/No preference (%)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eχ\u0026sup2;\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003eP\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003eCram\u0026eacute;r's V\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge Group\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e29.99\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.00001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.264\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e0\u0026ndash;30\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e34.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e29.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e36.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e31\u0026ndash;45\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e31.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e38.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e30.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e46\u0026ndash;60\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e54.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e27.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e17.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u0026ge;\u0026thinsp;61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e75.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e15.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e10.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVaccination Status\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e14.29\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.0064\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.163\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVaccinated\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e26.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e39.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e34.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNot vaccinated\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e49.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e28.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e22.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eScreening History\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e32.61\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.0001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.248\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eScreened\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e32.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e39.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e27.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eUnsure\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e35.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e35.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e30.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNever screened\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e72.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e6.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e20.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eTime Since Last HPV Test\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e29.58\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e0.0010\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.235\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eWithin 1 year\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e21.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e50.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e28.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMore than 1 year\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e44.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e30.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e26.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNever tested\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e65.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e14.3\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e20.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eComfort Evaluation\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e194.93\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.00001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.616\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSelf-sampling more comfortable\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e70.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e12.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e16.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eClinician sampling more comfortable\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e3.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e88.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e8.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAbout the same\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e5.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e21.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e73.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSelf-Sampling Pain Rating\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e\u003cp\u003e59.28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e\u003cp\u003e\u0026lt;\u0026thinsp;0.00001\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c7\"\u003e\u003cp\u003e0.352\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNo pain (0)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e49.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e26.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e24.0\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eslight pain (1\u0026ndash;3)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e22.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e42.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e35.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003emoderate-to-severe pain (\u0026ge;\u0026thinsp;4)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e10.5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e57.9\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e31.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eFurther multifactorial logistic regression analysis identified three independent predictors of self-sampling preference: comfort score (OR\u0026thinsp;=\u0026thinsp;9.78, 95%CI: 5.12\u0026ndash;18.67), age\u0026thinsp;\u0026ge;\u0026thinsp;46 years (OR\u0026thinsp;=\u0026thinsp;2.81, 95%CI: 1.43\u0026ndash;5.52), and absence of screening history (OR\u0026thinsp;=\u0026thinsp;3.21, 95%CI: 1.58\u0026ndash;6.53). Notably, HPV vaccination history (OR\u0026thinsp;=\u0026thinsp;0.67, 95%CI: 0.37\u0026ndash;1.22) showed no independent association with self-sampling preference.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec25\" class=\"Section2\"\u003e\u003ch2\u003e3.7 Evaluation of Self-Sampling Practices\u003c/h2\u003e\u003cp\u003eThe survey revealed that 91.04% of participants successfully performed cervical self-sampling without challenges and independently adhered to the provided instructions. Among the 8.96% reporting difficulties, operational uncertainties predominated: confusion about swab tip detachment or sample preservation (58.33%), uncertainty regarding sampling adequacy or removal timing (41.67%), ambiguity about insertion depth markers (16.67%), and questions about rotational technique during sampling (16.67%). These results highlight critical gaps in user comprehension, specifically in technical execution and procedural clarity, directly guiding targeted improvements to instructional materials and competency-based training protocols for these operational challenges.\u003c/p\u003e\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eThis study demonstrates that cervical self-sampling achieves near-perfect concordance with clinician-collected samples for HPV genotyping (κ\u0026thinsp;=\u0026thinsp;0.937, 95% CI:0.89\u0026ndash;0.98). The molecular analysis revealed equivalent diagnostic performance between methods: 91.4% sensitivity (detecting true positives) and 100% specificity (excluding false positives), with an overall accuracy of 97.5%. Notably, both modalities showed identical positive predictive values (100%), while the negative predictive value of self-sampling reached 96.5%. Critically, no statistically significant difference emerged in high-risk HPV detection rates between self- and clinician-sampling, robustly validating self-sampling as a reliable alternative for HPV genetic testing in cervical cancer screening programs.\u003c/p\u003e\u003cp\u003eThe acceptability analysis revealed tiered preference for self-sampling, with 41.42% of participants expressing immediate preference that increased to 56.72% when cost considerations were introduced. Three patient-centered factors emerged as key drivers for choosing self-sampling: comfort (59.21%), privacy protection (56.58%), and reduced pain perception (57.24%). These findings align with a large-scale validation study (N\u0026thinsp;=\u0026thinsp;8,136) in China's remote regions [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e], where self-sampling acceptance reached 62.37%, with convenience (32.66%), privacy (21.84%), and pain reduction (21.18%) serving as comparable motivators; proportional differences between studies are attributable to distinct questionnaire designs (single- vs. multiple-choice formats).\u003c/p\u003e\u003cp\u003eThe highest acceptance rate (72.4%) was observed among cervical cancer screening-na\u0026iuml;ve women, underscoring self-sampling's potential to bridge screening gaps in historically underserved populations. This evidence base supports targeted deployment of direct-mail self-sampling kits to priority groups, including due/overdue screeners and non-adherent populations, where this modality demonstrates enhanced screening efficacy [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Furthermore, self-sampling addresses critical healthcare challenges by facilitating HPV testing implementation in resource-limited settings lacking routine screening infrastructure while simultaneously providing a viable alternative for maintaining cervical cancer screening continuity during public health emergencies such as the COVID-19 pandemic [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eNotably, a Dutch population-based study (n\u0026thinsp;=\u0026thinsp;840,428) revealed critical challenges in self-sampling implementation: clinician-collected specimens demonstrated superior follow-up adherence, as HR-HPV-positive women using self-sampling faced significantly elevated risks of triage non-compliance (OR\u0026thinsp;=\u0026thinsp;3.87, 95%CI 3.55\u0026ndash;4.23), colposcopy attrition, and loss-to-follow-up compared to physician-sampled counterparts [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. These findings highlight the imperative of implementing a tripartite strategy: (1) rigorous tracking systems for self-sampling positives, (2) enhanced patient health literacy programs to address follow-up barriers, and (3) development of streamlined triage protocols requiring fewer clinical visits. Such measures are essential to mitigate downstream attrition risks that currently undermine program efficacy while preserving self-sampling's coverage advantages.\u003c/p\u003e\u003cdiv id=\"Sec27\" class=\"Section2\"\u003e\u003ch2\u003e4.2 Methodological and Clinical Strengths\u003c/h2\u003e\u003cp\u003eThree key methodological strengths distinguish this investigation. First, the prospective matched-pair design enabled direct intra-individual comparison between self-collected and clinician-obtained specimens, effectively eliminating confounding from inter-subject variability through sequential dual sampling. Second, we systematically mapped the associations between critical demographic determinants (age, screening history) and sampling modality preferences, generating actionable evidence for stratified implementation strategies. Third, the study employed a novel self-sampling device ergonomically optimized to accommodate the anatomical characteristics of Chinese women's cervical canals, a technical refinement that may enhance sampling adequacy compared to conventional designs.\u003c/p\u003e\u003cp\u003eGuided by established evidence showing higher self-sampling acceptance among urban residents and individuals with advanced education [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e], we strategically selected a Shanghai-based cohort to simultaneously evaluate diagnostic performance (via histopathological confirmation) and user acceptability metrics (through structured questionnaires). This dual assessment framework not only validated the device's clinical reliability but also quantified its social receptivity in a population with concentrated healthcare resources, thereby providing a comprehensive evidence base for scaling self-sampling programs in metropolitan settings.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec28\" class=\"Section2\"\u003e\u003ch2\u003e4.3 Limitations\u003c/h2\u003e\u003cp\u003eThis study has several limitations that warrant careful consideration. The statistical robustness may be constrained by the moderate sample size (N\u0026thinsp;=\u0026thinsp;276), particularly in subgroup analyses. Conducted at a single medical center with predominantly urban participants, the findings may lack generalizability to rural and remote populations, thereby inadequately reflecting China's diverse demographic landscape. Furthermore, the self-sampling procedure was administered under researcher supervision rather than in unsupervised home environments, potentially overestimating accuracy in real-world implementation. The cross-sectional design also precludes assessment of long-term outcomes, including the sustained impact of self-sampling on CIN2\u0026thinsp;+\u0026thinsp;detection rates and cervical cancer incidence reduction.\u003c/p\u003e\u003cp\u003eAdditionally, the cost-related questions in the survey relied on hypothetical payment scenarios rather than actual financial decisions, which may inflate willingness-to-pay estimates. Future research should incorporate revealed-preference experiments with tiered pricing models for self-sampling kits to quantify price elasticity. Multilevel analyses are needed to examine geographic disparities in cost sensitivity (e.g., high-income vs. low-income regions) and evaluate insurance reimbursement frameworks (e.g., integration with public healthcare or commercial insurance coverage). Such investigations could identify economic thresholds to enhance affordability and expand HPV screening coverage, particularly through policy innovations that subsidize self-sampling costs or integrate home-based testing into national prevention programs.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec29\" class=\"Section2\"\u003e\u003ch2\u003e4.4 Clinical and Public Health Implications\u003c/h2\u003e\u003cp\u003eThis study provides empirical support for integrating cervical self-sampling as a complementary strategy to clinician-collected sampling, particularly in populations with suboptimal screening coverage. The inherent advantages of self-sampling\u0026mdash;enhanced accessibility, privacy protection, and reduced procedural discomfort\u0026mdash;position it as a viable intervention to improve HPV screening adherence.\u003c/p\u003e\u003cp\u003eA key finding reveals the critical role of cost differentials in modality selection: when self-sampling was priced at 200 CNY compared to 300 CNY (plus time costs) for clinic-based sampling, preference rates increased by 15.3 percentage points. This finding suggests that even in economically developed regions, price factors can influence respondents' choices. Of course, respondents in economically developed regions place greater emphasis on the opportunity cost of lost time than those in middle- and low-income regions. Therefore, through reasonable pricing strategies and medical insurance policy support, coupled with improvements in the efficiency of medical visits, self-sampling is expected to achieve broader coverage.\u003c/p\u003e\u003cp\u003eThree implementation pathways warrant prioritization: First, hospital-based distribution of self-sampling kits with postal return systems could decentralize screening access. Second, community health centers could operationalize standardized training protocols to ensure procedural competency. Third, mobile health platforms should be leveraged to provide real-time instructional support, particularly in resource-limited settings. Tailored communication strategies are equally vital\u0026mdash;emphasizing privacy and convenience for younger demographics, while highlighting simplified protocols and minimal discomfort for older populations. Such multidimensional approaches could catalyze the integration of self-sampling into national cervical cancer prevention programs, ultimately advancing health equity across socioeconomic strata.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec30\" class=\"Section2\"\u003e\u003ch2\u003e4.5 Future Research Directions\u003c/h2\u003e\u003cp\u003eBuilding upon current evidence, five research priorities emerge requiring systematic investigation. First, large-scale multicenter validation studies should expand sample sizes across diverse geographic regions and demographic subgroups, particularly addressing variations by age, education level, and urban/rural residency to strengthen generalizability. Second, real-world accuracy assessments must evaluate self-sampling performance in unsupervised home environments, with dedicated focus on operational errors among populations with differing educational backgrounds. Third, the development of digital assistance tools warrants urgent attention, including mobile app-guided video tutorials for standardized sampling procedures and AI-driven quality control systems to overcome challenges in sample preservation and adequacy evaluation. Fourth, longitudinal clinical impact studies through sustained follow-up are needed to establish self-sampling's effectiveness in precancerous lesion detection and early cervical cancer diagnosis. Finally, comprehensive cost-benefit analyses comparing self-sampling with clinic-based methods should quantify direct medical costs, time expenditures, and systemic healthcare burdens.\u003c/p\u003e\u003c/div\u003e"},{"header":"5. Conclusions","content":"\u003cp\u003eThis study demonstrates that the novel cervical self-sampling device achieves high diagnostic performance for HPV genotyping, with 91.4% sensitivity and 100% specificity, showing near-perfect concordance with physician-collected samples (κ=0.937). Notably, over half of participants (56.72%) preferred self-sampling after cost considerations, with 71.64% reporting pain-free experiences compared to 22.39% in clinician-assisted sampling, underscoring its advantages in comfort and tolerability. Demographic analysis revealed stronger preference among individuals aged ≥46 years, those without prior screening history, and participants perceiving enhanced procedural comfort. In addition, even patients in economically developed regions are more likely to accept self-sampling testing due to price factors and time costs.\u003c/p\u003e\n\u003cp\u003eWhile cervical self-sampling serves as a practical complement to clinician-based methods and holds potential to expand screening coverage-particularly for underscreened populations—its clinical implementation requires addressing operational training needs and inter-genotype detection sensitivity variations. As technological refinements and practical experience accumulate, this approach is positioned to become a pivotal tool in China's cervical cancer prevention strategy, bridging gaps in early detection accessibility.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eCRediT authorship contribution statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBowen Xu\u003c/strong\u003e: Conceptualization; Investigation; Methodology; Writing - original draft. \u003cstrong\u003eJingjing Liu\u003c/strong\u003e: Data curation; Formal analysis. \u003cstrong\u003eHui Li\u003c/strong\u003e: Data curation; Investigation.\u0026nbsp;\u003cstrong\u003eTingting Zhang\u003c/strong\u003e: Supervision; Validation; Writing - review \u0026amp; editing. \u003cstrong\u003eFang Li\u003c/strong\u003e: Project administration; Resources.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study received ethical clearance from the Institutional Review Board of Shanghai East Hospital (Ethical Review Number: 2024YS-182; Approval Date: 15 August 2024) and was prospectively registered with the Chinese Clinical Trial Registry (Registration ID: ChiCTR2500100121). All participants signed a written informed consent form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was supported by the Pudong New Area ‘National Experimental Zone for Comprehensive Reform of Chinese Medicine Development’ Construction Project（PDZY-2023-1104）;The National Natural Science Foundation of China (NSFC; 82273091).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of competing interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors acknowledge Mrs Wenjuan Ji，the staff of Shanghai SanteFam Healthcare Technology Co., Ltd. for hers assistance in participant training.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eBray, F., et al., Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 2024. 74(3): p. 229-263.\u003c/li\u003e\n\u003cli\u003eWHO guideline for screening and treatment of cervical pre-cancer lesions for cervical cancer prevention: Use of dual-stain cytology to triage women after a positive test for human papillomavirus (HPV). WHO Guidelines Approved by the Guidelines Review Committee. 2024, Geneva: World Health Organization.\u003c/li\u003e\n\u003cli\u003eHan, B., et al., Cancer incidence and mortality in China, 2022. Journal of the National Cancer Center, 2024. 4(1): p. 47-53.\u003c/li\u003e\n\u003cli\u003eCrosbie, E.J., et al., Human papillomavirus and cervical cancer. Lancet, 2013. 382(9895): p. 889-99.\u003c/li\u003e\n\u003cli\u003eSchiffman, M. and N. Wentzensen, Human Papillomavirus Infection and the Multistage Carcinogenesis of Cervical Cancer. Cancer Epidemiology, Biomarkers \u0026amp; Prevention, 2013. 22(4): p. 553-560.\u003c/li\u003e\n\u003cli\u003eBertoli, H.K., et al., Risk of vulvar, vaginal and anal high-grade intraepithelial neoplasia and cancer according to cervical human papillomavirus (HPV) status: A population-based prospective cohort study. Gynecologic Oncology, 2020. 157(2): p. 456-462.\u003c/li\u003e\n\u003cli\u003eChen, G., et al., Prevalence and genotype distribution of human papillomavirus in women with cervical cancer or cervical intraepithelial neoplasia in Henan province, central China. Journal of Medical Virology, 2020. 92(12): p. 3743-3749.\u003c/li\u003e\n\u003cli\u003eWei, F., et al., Causal attribution of human papillomavirus genotypes to invasive cervical cancer worldwide: a systematic analysis of the global literature. The Lancet (British edition), 2024. 404(10451): p. 435-444.\u003c/li\u003e\n\u003cli\u003eCuzick, J., et al., Overview of Human Papillomavirus-Based and Other Novel Options for Cervical Cancer Screening in Developed and Developing Countries. Vaccine, 2008. 26: p. K29-K41.\u003c/li\u003e\n\u003cli\u003eWright, T.C., et al., Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test. Gynecologic Oncology, 2015. 136(2): p. 189-197.\u003c/li\u003e\n\u003cli\u003eLi MZ, et al. Chinese Guidelines for Cervical Cancer Screening (I). Modern Advances in Obstetrics and Gynecology. 2023;32(7):481-487.\u003c/li\u003e\n\u003cli\u003eBorek, A.J., et al., Acceptability of self-sampling and self-testing for infections: a rapid systematic review on public users\u0026rsquo; views. BMC Public Health, 2025. 25(1).\u003c/li\u003e\n\u003cli\u003eGravitt, P.E., et al., Looking ahead: A case for human papillomavirus testing of self‐sampled vaginal specimens as a cervical cancer screening strategy. International Journal of Cancer, 2011. 129(3): p. 517-527.\u003c/li\u003e\n\u003cli\u003eHillemanns, P., et al., Screening for cervical neoplasia by self-assessment for human papillomavirus DNA. The Lancet (British edition), 1999. 354(9194): p. 1970-1970.\u003c/li\u003e\n\u003cli\u003eTatara, T., et al., The Influence of Vaginal HPV Self-Sampling on the Efficacy of Populational Screening for Cervical Cancer\u0026mdash;An Umbrella Review. Cancers, 2022. 14(23): p. 5913.\u003c/li\u003e\n\u003cli\u003eYeh, P.T., et al., Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis. BMJ Global Health, 2019. 4(3): p. e001351.\u003c/li\u003e\n\u003cli\u003eStyffe, C., et al., HPV Self-sampling in Indigenous Communities: A Scoping Review. Journal of Immigrant and Minority Health, 2020. 22(4): p. 852-859.\u003c/li\u003e\n\u003cli\u003eMezei, A.K., et al., Cost-effectiveness of cervical cancer screening methods in low- and middle-income countries: A systematic review. International Journal of Cancer, 2017. 141(3): p. 437-446.\u003c/li\u003e\n\u003cli\u003eMalone, C., et al., Cost-effectiveness studies of HPV self-sampling: A systematic review. Preventive Medicine, 2020. 132: p. 105953.\u003c/li\u003e\n\u003cli\u003eAtkinson, A.E., et al., Screening for Human Papillomavirus in a Low- and Middle-Income Country. Journal of global oncology, 2019. 5(5): p. JGO1800233-JGO1800233.\u003c/li\u003e\n\u003cli\u003eCampos, N.G., et al., Cervical cancer screening in low‐resource settings: A cost‐effectiveness framework for valuing tradeoffs between test performance and program coverage. International Journal of Cancer, 2015. 137(9): p. 2208-2219.\u003c/li\u003e\n\u003cli\u003eParapob, N., et al., A comparative study of self-collected versus clinician-collected specimens in detecting high-risk HPV infection: a prospective cross-sectional study. Obstetrics \u0026amp; Gynecology Science, 2024. 67(6): p. 557-564.\u003c/li\u003e\n\u003cli\u003eWHO, World Health Organization (WHO). Self‐care interventions: human papillomavirus (HPV) self‐sampling as part of cervical cancer screening and treatment, 2022 update. 2023.\u003c/li\u003e\n\u003cli\u003eSerrano, B., et al., Worldwide use of HPV self-sampling for cervical cancer screening. Preventive Medicine, 2022. 154: p. 106900.\u003c/li\u003e\n\u003cli\u003eLi, J., et al., Effectiveness and feasibility of self-sampling for human papillomavirus testing for internet-based cervical cancer screening. Frontiers in Public Health, 2022. 10.\u003c/li\u003e\n\u003cli\u003eWiner, R.L., et al., Strategies to Increase Cervical Cancer Screening With Mailed Human Papillomavirus Self-Sampling Kits. JAMA, 2023. 330(20): p. 1971.\u003c/li\u003e\n\u003cli\u003eParker, S., et al., Perceived barriers to cervical cancer screening and motivators for at-home human papillomavirus self-sampling during the COVID-19 pandemic: Results from a telephone survey. Elife, 2023. 12.\u003c/li\u003e\n\u003cli\u003eAjenifuja, K.O., et al., Designing low-cost, accurate cervical screening strategies that take into account COVID-19: a role for self-sampled HPV typing. Infectious Agents and Cancer, 2020. 15(1).\u003c/li\u003e\n\u003cli\u003eOlthof, E.M.G., et al., The impact of loss to follow‐up in the Dutch organised HPV‐based cervical cancer screening programme. International Journal of Cancer, 2024. 154(12): p. 2132-2141.\u003c/li\u003e\n\u003cli\u003eShao, J., et al., Knowledge, attitudes, and practices of human papillomavirus and self-sampling among adult women: a cross-sectional study. Frontiers in Public Health, 2024. 12.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Cervical Cancer Screening, HPV Self-collection, Diagnostic Accuracy, Patient-centered Care, Screening Adherence, Economically Developed Regions","lastPublishedDoi":"10.21203/rs.3.rs-7693739/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7693739/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eTo evaluate the diagnostic accuracy and clinical applicability of a novel cervical self-sampling device for HPV genotyping, and to determine the factors influencing patient preference for self-collection methods in economically developed regions.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003e In this prospective paired-sample study conducted at Shanghai East Hospital (September 2024-February 2025), 276 high-risk women from gynecological outpatient clinics under-went sequential cervical sampling: self-collection followed by clinician-administered sampling. Both specimens underwent parallel HPV genotyping analysis using standardized protocols. Using clinician sampling as the reference standard, we calculated diagnostic parameters including sensitivity, specificity, and predictive values with 95% confidence intervals. Patient-reported outcomes (n\u0026thinsp;=\u0026thinsp;268 valid responses) assessing acceptability, comfort level, and preference were collected through a structured questionnaire.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eThe self-sampling method demonstrated excellent concordance with clinician sampling (κ\u0026thinsp;=\u0026thinsp;0.937; 95% CI:0.89\u0026ndash;0.98). Diagnostic performance metrics were as follows: sensitivity 91.4% (83.2\u0026ndash;96.5%), specificity 100% (98.2\u0026ndash;100%), accuracy 97.5% (94.8\u0026ndash;99.0%), positive predictive value 100% (95.0-100%), and negative predictive value 96.5% (93.2\u0026ndash;98.5%). While 41.4% of participants initially preferred self-sampling, this proportion increased to 56.7% when considering cost factors. Key determinants for self-sampling preference included: home-based collection comfort (59.2%), perceived pain reduction through self-controlled sampling pressure (57.2%), and privacy preservation (56.6%). Multivariate analysis revealed significant associations between sampling preference and age (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001), HPV vaccination status (p\u0026thinsp;=\u0026thinsp;0.0064), previous screening experience (p\u0026thinsp;=\u0026thinsp;0.0064), and comfort perception (p\u0026thinsp;\u0026lt;\u0026thinsp;0.0001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eThe novel self-sampling device achieves diagnostic accuracy comparable to clinician-collected specimens while demonstrating superior patient acceptability. Its ad-vantages in privacy protection, procedural comfort, and cost-effectiveness position it as a promising complementary strategy to enhance cervical cancer screening coverage, particularly among under-screened high-risk populations.\u003c/p\u003e","manuscriptTitle":"Diagnostic Accuracy and Acceptability of a Novel Human Papillomavirus Self-Collection Tool for Cancer Screening in Eco-nomically Developed Regions: A Prospective Cohort Study in Shanghai, China","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-10 14:48:04","doi":"10.21203/rs.3.rs-7693739/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"011b6855-65d8-421b-9081-628c2581afad","owner":[],"postedDate":"October 10th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-12-31T12:38:17+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-10 14:48:04","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7693739","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7693739","identity":"rs-7693739","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}