OBJECTIVE:To evaluate and compare the diagnostic performance of the Food and Drug Administration-approved APTIMA® human papillomavirus (HPV) assay (E6/E7 mRNA-based) and the Mygene HPV-STI Assay (MHSA) in detecting cervical intraepithelial neoplasia (CIN) 2+ and CIN3+ lesions among Chinese women in a screening setting. METHODS:A total of 3,166 women were enrolled from Wuxiang County, Shanxi Province, China, and followed for 3 years. APTIMA and MHSA were performed using cervical cytology specimens. Histopathology served as the reference standard. Diagnostic accuracy (sensitivity, specificity, and predictive values), assay concordance, and receiver operating characteristic (ROC) analyses were conducted for baseline and longitudinal detection of CIN2+/CIN3+. RESULTS:Among 2,683 women with complete follow-up, the prevalence of high-risk-HPV was 17.22% by APTIMA and 20.16% by MHSA. Substantial concordance was observed (κ=0.798). APTIMA showed higher specificity than MHSA when combined with cytology (CIN2+: 88.42% vs. 87.96%, p=0.038; CIN3+: 87.28% vs. 86.87%, p=0.063), while sensitivity and predictive values were comparable. The MHSA demonstrated broader HPV genotyping, while APTIMA yielded slightly superior performance in post-test probability for CIN3+ over 3 years. ROC analysis confirmed comparable diagnostic discrimination. CONCLUSION:Both assays offer high clinical accuracy within 3 years. While APTIMA remains the validated standard, the MHSA may serve as a promising next-generation sequencing-based alternative, particularly in expanded genotyping.

Cervical cancer (CC) remains a major health challenge worldwide. Early detection methods and screening strategies are important for reducing both incidence and mortality rates. This study evaluates the clinical performance of the real-time optoelectronic device, TruScreen (TS), in detecting high-grade cervical precancers compared to standard methods [high-risk human papillomavirus (hrHPV) testing, cytology, and colposcopy) in a Chinese hospital-based opportunistic screening cohort. In addition, assess the clinical effectiveness of the TS strategies alongside current guidelines and methodologies in cervical cancer screening. A multicenter, cross-sectional study was conducted across 64 hospitals between September 2018 and June 2021 in China. Participants (n = 14,982 women aged ≥ 20 years) underwent TS test, hrHPV test, liquid-based cytology (LBC), and colposcopy with biopsy confirmation. Diagnostic performance [sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV)] were calculated using histopathology as the gold standard. Strategies incorporating TS test were compared to WHO-recommended guidelines. For cervical intraepithelial neoplasia grade 2 and servier lesions (CIN2+), TS test demonstrated comparable sensitivity (87.0

The aim of this study is to develop a machine learning triage model for HR-HPV positive women based on methylation patterns of human and HPV genes to predict the risk of CIN2 +, and to compare its performance with traditional detection techniques. A total of 512 eligible women participated in the study, with exfoliated cervical cell specimens collected for methylation analysis of both human and HPV genes. Highly methylated gene fragments related to cervical cancer were identified through high density, high association, high MHL (Methylation Haplotype Load) screening and Logistic regression. The samples were divided into a training set and a validation set at a ratio of 7:3, and a machine learning triage model was constructed using CIN2+ as the outcome. Among 512 HR-HPV positive women, 174 (34.0%) had CIN2 +. To construct the random forest model, 10 high methylation human gene fragments were identified from a pool of 45 genes, along with HPV 16, 18, and 52 L2 genes. In the validation set, the random forest model identified 45 samples as positive (38 were true positives) and 112 samples as negative (96 were true negatives). The model achieved an AUC of 0.9, and DeLong test confirmed its performance was significantly superior (p < 0.001) to HPV 16/18 genotyping and cytology testing. The random forest model constructed based on methylation patterns of human and HPV genes demonstrated strong predictive efficacy for CIN2+ in HR-HPV positive women, and may optimize the triage method in cervical cancer screening.

OBJECTIVE:Novel human papillomavirus (HPV) tests must undergo thorough validation before implementation in the cervical cancer screening population. The MyGene HPV sexually transmitted infection (STI) assay (MHSA), an emerging test based on emerging next-generation sequencing, presents as a promising tool for enhancing detection capabilities in screening settings. This study aims to conduct a comparative analysis of the clinical performance of two assays (Cobas 4800 vs. MHSA) in detecting 14 high-risk (GR)-HPV genotypes for the identification of high-grade cervical intraepithelial neoplasia (CIN2+/CIN3+) in longitudinal cervical cancer screening among Chinese women. METHODS:A total of 2985 consecutive specimens from a cervical screening program in Erdos City were examined using both MHSA and Cobas 4800 assays. Follow-up study was also conducted for 3 years. RESULTS:The overall percent agreement (OPA), percentage of negative agreement (PNA), and Kappa statistics for 14 HR-HPV positivity, type-specific HPV16, HPV18, and 12 other HR-HPV demonstrated strong concordance between the two assays. The clinical performance of MHSA was comparable to the Cobas 4800 assay at both baseline and over the 3-year cumulative follow-up. Moreover, MHSA effectively reduced unnecessary colposcopy referrals and showed better triage efficiency both at baseline and at the 3-year follow-up. When combined with HPV typing and cytology results, MHSA outperforms the Cobas 4800 in terms of clinical performance and triage efficiency. CONCLUSION:Our study indicated that MHSA could be considered a valuable option for cervical cancer screening in China.

Tailored cervical cancer screening strategies are essential, particularly in resource-limited settings. This study aimed to assess the genotype-specific impact of high-risk human papillomavirus (HR-HPV) infections on cervical cytological progression over a 3-year interval among Chinese women, thereby providing evidence for more precise and individualized screening approaches. A multicenter cohort was established in 2017 across three Chinese provinces. Participants underwent baseline HPV genotyping and cytological examination, with genotyping for five high-risk types (HPV16, 18, 33, 52, and 58), and follow-up evaluations conducted from 2018 to 2020. Cytological progression was defined as a transition from normal cytology (negative for intraepithelial lesion or malignancy, NILM) at baseline to low-grade squamous intraepithelial lesion (LSIL) or worse at the final follow-up. A total of 7240 women were included to evaluate the cytological progression. The overall progression rate was 0.7%, with a notably higher rate among HR-HPV-positive women (2.1%) compared to HR-HPV-negative women (0.5%). Specifically, HPV16, HPV52, and HPV58 were significantly associated with an increased risk of progression, with adjusted odds ratios (aORs) of 6.26 (95% CI: 2.62-14.95), 6.68 (95% CI: 3.30-13.53), and 4.24 (95% CI: 1.51-11.94), respectively. Moreover, women with persistent infections with HPV16, HPV52, and HPV58 had approximately 8-fold, 6-fold, and 5-fold higher risks of progression, respectively, compared with women without infections. Stratified management based on high-risk genotypes-particularly HPV16, HPV52, and HPV58-may help prioritize colposcopy and more intensive follow-up for women at elevated risk, which could contribute to cervical cancer prevention efforts. Trial Registration: Chinese Clinical Trial Registry Center of the World Health Organization International Clinical Trials Registry Platform number: ChiCRT2200055287.

Objective To provide a comprehensive review of the surgical methods for repairing post-epicanthoplasty deformity,aiming to offer a reference for clinical decision-making in selecting appropriate techniques.Methods Relevant research literature concerning the repair of post-epicanthoplasty deformities was extensively reviewed.The background,clinical applications,and current challenges of these reconstructive procedures were summarized and analyzed.Results Post-epicanthoplasty deformities are not uncommon,and with evolving aesthetic standards,the demand for medial canthal reconstruction is increasing.The primary surgical techniques reported in the literature include the V-Y advancement flap,the reverse skin-redraping method,and the reverse Z-plasty.In recent years,the application of orbicularis oculi myocutaneous flaps has become more prevalent.While most of these procedures yield satisfactory outcomes,they still face certain limitations,particularly in addressing challenges related to scar management,individual patient variations,and the precise control of medial canthal morphology.Conclusion When clinically addressing post-epicanthoplasty deformities,surgeons must select the most suitable surgical method based on a comprehensive assessment of the patient's specific condition and various contributing factors.An individualized approach is crucial to achieving the optimal aesthetic and functional outcomes.

To evaluate the risk of cervical intraepithelial neoplasia, grade 2 or worse (≥ CIN2) in women with normal cervical cytology using extended high-risk human papillomavirus (HR-HPV) genotyping. This study is a population-based, nationwide, multi-center prospective cohort study. A subset of 6853 women with normal cytology and HPV testing results using an extended genotyping assay were included in the analysis. The odds ratio (OR) and adjusted OR (aOR) was calculated using univariate analyses and multivariate logistic regression, with HPV negative and other 9 HR-HPV-positive genotypes (HPV 31, 35, 39, 45, 51, 56, 59, 66, and 68) as reference, respectively. The 3-year cumulative absolute risk was calculated. Over the study period, 87 ≥ CIN 2 cases were identified. Most ≥ CIN 2 cases were positive for HPV 16 (50.6%) or HPV 33/52/58 (46.0%) at baseline. Compared to other 9 h-HPV, HPV 16 (aOR = 20.5, 95% CI: 8.5-49.5), HPV18 (aOR = 10.1, 95% CI: 3.2-31.8), and HPV 33/52/58 (aOR = 4.8, 95% CI: 2.0-11.8) were significantly associated with higher risk of ≥ CIN 2. HPV 16 and 33 had the highest cumulative absolute risk of ≥ CIN2 (25.9% and 22.2%), followed by HPV 18 (15.4%), HPV 58 (11.3%), and HPV 52 (8.1%). Other 9 h-HPV had a lower risk of ≥ CIN 2 (4.7%). Extended HPV genotyping beyond HPV 16/18 (e.g., HPV 33, 52, and 58) might be effective for risk stratification in women with normal cervical cytology. The management of HPV-positive women based on refined genotype-based risk estimations may be a promising strategy for cervical cancer screening. The study was registered at the Chinese Clinical Trial Registry Center of the World Health Organization International Clinical Trials Registry Platform (Registration number ChiCRT2200055287).

To evaluate the clinical performance of Hybribio's 14-type HPV real-time PCR with 16/18 genotyping (HBRT-H14) and its risk stratification utility among women with normal cytology (NILM). From 2017 to 2020, a multicenter cohort enrolled 8,401 women aged 30-64 years with NILM cytology. Baseline HPV testing used HBRT-H14. Women positive for HPV 16/18 were referred for colposcopy; follow-up was annual for 3 years or until the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+). Analyses included 6,679 women who completed follow-up. Overall HPV positivity was 11.4%, including 2.3% HPV 16/18. Over 3 years, sensitivity and specificity of HPV positivity for CIN2+ were 92.3% (95% confidence interval [CI]: 84.2-96.4) and 89.6% (88.8-90.3). For HPV 16/18 positivity, sensitivity and specificity were 41.0% (30.8-52.1) and 98.2% (97.8-98.5). Three-year cumulative CIN2+ risk was 20.9% (15.2-28.1) for HPV 16/18-positive women, 6.6% (4.9-8.9) for other types, and 0.1% (0.04-0.2) for HPV-negative women. HBRT-H14 shows strong clinical performance for detecting CIN2+, and HPV 16/18 genotyping provides effective risk stratification among women with NILM cytology. Findings support integration of HBRT-H14 into HPV-based screening pathways with HPV 16/18 genotyping and cytology triage of other types.IMPORTANCEThis multicenter prospective study evaluated the Hybribio 14 high-risk HPV real-time PCR assay (HBRT-H14) in 8,401 women with normal (NILM) cytology under guideline-based follow-up. The assay showed high clinical sensitivity and a very low risk among HPV-negative women, and HPV 16/18 genotyping provided clear risk stratification. These findings deliver large-scale, practice-oriented evidence supporting integration of HBRT-H14 into HPV-based screening pathways that use HPV 16/18 genotyping with cytology triage of other types.

OBJECTIVE:The co-expression of P16 and Ki67 suggests the presence of high-grade cervical intraepithelial neoplasia, which makes P16/Ki67 dual staining a promising marker in cervical cancer screening. This study provides a systemic review of the established evidence on the performance of P16/Ki67 versus cytology in detecting cervical intraepithelial neoplasia (CIN)2+/CIN3+ among high-risk human papillomavirus (HR-HPV)-positive women and HR-HPV-positive individuals with cytology-negative results for triage management. METHODS:Studies published from database inception to April 26, 2024, were systematically searched. A total of 26 studies were eventually included in the study, comprising 26,424 women, with 14,625 classified as P16/Ki67-positive and 11,799 as P16/Ki67-negative. RESULTS:In the triage management of HR-HPV-positive women, P16/Ki67 achieved sensitivities of 85% for CIN2+ and 88% for CIN3+, with specificities of 63% and 57%, respectively. In comparison, cytology showed lower sensitivities of 76% for CIN2+ and 79% for CIN3+, with lower specificities of 57% and 54%. In triage management of human papillomavirus (HPV)-positive but cytology-negative women, 18.48% of the HPV-positive patients, initially missed by cytology, were correctly retrieved by the addition of P16/Ki67. A negative P16/Ki67 test result reduced the risk of underlying CIN3+ to 4% for HR-HPV-positive individuals and 1% for the HR-HPV-positive individuals with cytology-negative results, prompting a recommendation for follow-up at 1-year intervals. CONCLUSION:P16/Ki67 exhibits diagnostic superiority over liquid-based cytology in detecting CIN2+/CIN3+, among HR-HPV-positive women. Furthermore, its ability to identify patients missed by cytology highlights its value as a complementary tool for triage of HR-HPV-positive but cytology-negative population. By effectively reducing unnecessary colposcopy referrals, P16/Ki67 conserves healthcare resources and improves outcomes. TRIAL REGISTRATION:PROSPERO Identifier: CRD42024567623.

Cervical cancer remains a significant health burden, and effective screening is essential, yet the age-specific performance of HPV primary screening is rarely studied. This multicenter study evaluates age-specific performance of primary human papillomavirus (HPV) testing as cross-sectional and longitudinal screening for cervical cancer among 28,501 Chinese women. At baseline, HPV screening with cytology triage demonstrates higher sensitivity (96.9

OBJECTIVE:Persistent high-risk human papillomavirus (HR-HPV) infection is an essential risk factor for HPV-associated adenocarcinomas (HPVA). A three-tier pattern system (the Silva pattern) for endocervical adenocarcinoma (ECA) associated with tumor metastasis and recurrence was described by Elvio G. Silva nearly 10 years ago. However, there are no studies on the association between HPV genotypes and Silva patterns. METHODS:The Silva pattern classification was performed on 240 surgical HPVA specimens according to the 2020 World Health Organization classification of female genital tract cancers. HPV DNA was detected using the SPF10-DEIA-LiPA25 assay for all specimens and an attribution algorithm was used to calculate the attribution rate of HPV16/18. RESULTS:Out of all HPVA cases, 29 patients (12.1%) were found to have tumors with Silva pattern A, 122 (50.8%) had pattern B tumors, and 89 (37.1%) had pattern C (representing the worst morphological behavior, poorest prognosis and highest risk of mortality). The crude prevalence of HPV16 and 18 was 46.9% and 44.7%, respectively. The attribution of HPV16 in Silva patterns A, B, and C was 58.0%, 51.7%, and 33.8%, respectively (P = 0.123). Similarly, the attribution of HPV18 was found to be 29.8%, 39.7%, and 49.5% in patterns A, B, and C, respectively. Notably, there was a statistically significant positive linear relationship between the prevalence of HPV18 and the Silva pattern from A to C (P = 0.002). CONCLUSION:HPV16 and 18 are the most prevalent HPV subtypes in patients with HPVA. HPVA patients who are infected with HPV18 exhibit worse morphological behavior compared to those with the HPV16 genotype.

OBJECTIVES:We aimed to assess the clinical performance of DH3, a hybrid capture assay that separately detects human papillomavirus (HPV) 16/18 and 12 other HPV types, for primary screening for cervical cancer in the general population, following Chinese guidelines. METHODS:A total of 9379 eligible women aged 21 to 64 years from three centres underwent baseline screening with DH3 and liquid-based cytology (LBC), and were subsequently followed for 3 years. The diagnostic performance of HPV testing (DH3) and LBC-including sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value-was evaluated for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions. RESULTS:At baseline, 146 (1.56%) participants were identified with CIN2+ lesions. Compared with LBC with reflex high-risk HPV (HR-HPV), primary HR-HPV with reflex LBC showed a significantly higher sensitivity (95.89% [95% CI: 91.33%-98.10%] vs. 84.93% [95% CI: 78.24%-89.83%], PMcNemar[McN] = 0.004), and a marginally lower specificity (89.65% [95% CI: 89.01%-90.25%] vs. 91.61% [95% CI: 91.02%-92.15%], PMcN <0.001) for detecting CIN2+. 7747 (82.6% follow-up rate) women completed the 3-year follow-up, during which 236 (3.00%) were cumulatively diagnosed with CIN2+. HR-HPV with reflex LBC demonstrated significantly higher sensitivity than LBC with reflex HR-HPV (91.95% [95% CI: 87.77%-94.79%] vs. 63.56% [95% CI: 57.25%-59.44%], PMcN <0.001), whereas both methods exhibited similar specificity (90.57% [95% CI: 89.89%-91.21%] vs. 91.37% [95% CI: 90.72%-91.99%], PMcNr = 0.062) for CIN2+. The colposcopy referral rates for the two algorithms were also comparable (5.77% (447/7747) vs. 5.38% (417/7747), p 0.294). In addition, individuals positive for HPV16/18 had a 3-year absolute risk of CIN2+ exceeding 48%. In comparison, the risk was only 0.28% (19/6822) in the HPV-negative population, markedly >1.24% (86/6949) risk observed in individuals with normal cytology. Limiting the analysis to women aged ≥30 yielded similar results. DISCUSSION:Our study indicates that DH3 exhibits dependable clinical performance in cervical screening. The validated HPV test is expected to enhance the quality of population-based screening.

Deep learning (DL) enabled liquid-based cytology has potential for cervical cancer screening or triage. Here, we develop a DL model using whole cytology slides from 17,397 women and test it on 10,826 additional cases through a three-stage process. The DL model achieves robust performance across nine hospitals. In a multi-reader, multi-case study, it outperforms cytopathologists' sensitivity by 9%. Reading time significantly decreases with DL assistance (218s vs 30s; p < 0.0001). In community-based organized screening, the DL model's sensitivity matches that of senior cytopathologists (0.878 vs 0.854; p > 0.999), yet it has reduced specificity (0.831 vs 0.901; p < 0.0001). Notably, hospital-based opportunistic screening shows that junior cytopathologists with DL assistance significantly improve both their sensitivity and specificity (0.857 vs 0.657, 0.840 vs 0.737; both p < 0.0001). When triaging human papillomavirus-positive cases, DL assistance exhibits better performance than junior cytopathologists alone. These findings support using the DL model as an assistance tool in cervical screening and case triage.

BACKGROUND:The p16/Ki-67 dual-staining is increasingly applied to increase diagnostic accuracy in detecting high-grade cervical lesions, including cervical intraepithelial neoplasia Grade 2 (CIN2+) and CIN3+. OBJECTIVES:To compare the diagnostic performance of p16/Ki-67 dual-staining with the human papillomavirus (HPV) tests in the triage of women with atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) cytology results. SEARCH STRATEGY:Publications before April 27, 2024, were identified through PubMed, Embase, Web of Science, and Cochrane Library. SELECTION CRITERIA:The studies have head-to-head comparison of p16/Ki-67 dual-staining and HPV testing in detecting high-grade cervical lesions. DATA COLLECTION AND ANALYSIS:Two researchers independently screened articles by title, abstract, and full text. The GRADE and QUADAS-2 tool was used for quality evaluation. The pooled sensitivity and specificity for CIN2+ and CIN3+ were estimated using random effects models, with results and heterogeneity assessments presented in forest plots. Pretest-posttest probability (PPP) plots were constructed to evaluate the detection rates of CIN3+ in ASC-US and LSIL patients. MAIN RESULTS:Twenty-one studies with 6394 participants were included. The pooled specificity of p16/Ki-67 dual-staining was higher than that of HPV tests (CIN2+: 0.73 [95% confidence interval [CI] 0.65-0.80] versus 0.41 [95% CI 0.33-0.50]; CIN3+: 0.61 [95% CI 0.53-0.69] versus 0.33 [95% CI 0.23-0.45]). Summary receiver operating characteristic curve analysis demonstrated p16/Ki-67 dual-staining had better diagnostic accuracy for CIN2+ than HPV tests (area under the curve: 0.88 [95% CI 0.85-0.90] versus 0.79 [95% CI 0.75-0.82]). Pretest-posttest probability (PPP) plots highlighted the superior performance of p16/Ki-67 dual-staining for colposcopy referrals in LSIL patients. CONCLUSIONS:P16/Ki-67 dual-staining offers greater specificity for detecting CIN2+/CIN3+ in ASC-US and LSIL triage, particularly for LSIL. It holds potential as an alternative to HPV tests in resource-limited settings or LSIL cases, warranting further research to refine its application in diverse populations.

Previous studies showed the association between sexually transmitted infections (STIs) and cervical lesions remains ambiguous. This study was conducted among 8371 women from a screening cohort. Seven specific sexually transmitted pathogens (STPs), including one viral [high-risk human papillomavirus (hrHPV), low-risk HPV (lrHPV)], five bacterial [Ureaplasma parvum (UP), Mycoplasma hominis (MH), Ureaplasma urealyticum (UU), Chlamydia trachomatis (CT), and Mycoplasma genitalium (MG)], and one parasitic [Trichomonas vaginalis (TV)] pathogen, were tested by Next Generation Sequencing assay using well-stored baseline samples. Odds ratios (ORs) for incident cervical lesions with different STPs were calculated by Logistic Regression analysis. Within 3-year follow-up, 133 and 72 participants were diagnosed with histopathological cervical intraepithelial neoplasia grade 1 (CIN1) and CIN2+, respectively. The adjusted ORs (aORs) of atypical squamous cells of undetermined significance or worse (ASC-US+) for women with hrHPV, lrHPV, UP, MH, TV, CT, and MG infections were 2.62 (95% CI: 2.19-3.13), 1.94 (95% CI: 1.55-2.43), 1.48 (95% CI: 1.26-1.74), 1.47 (95% CI: 1.25-1.73), 1.65 (95% CI: 1.27-2.15), 1.26 (95% CI: 0.79-2.01) and 2.33 (95% CI: 1.41-3.85), respectively. The aORs of cytological high-grade squamous intraepithelial lesions (HSIL) for women with hrHPV, TV, and MG infections were 13.01 (95% CI: 5.78-29.31), 3.48 (95% CI: 1.38-8.75), and 5.87 (95% CI: 1.58-21.77). The aORs of CIN1 for hrHPV, lrHPV, and MH were 6.88(95% CI: 4.79-9.90), 2.04(95% CI: 1.29-3.14), and 1.47(95% CI: 1.02-2.11). The aOR of CIN2+ for women with hrHPV infection was 17.56 (95% CI: 10.31-29.92), no significance was observed for CIN2+ with non-hrHPV STIs. Specific STP infections were significantly associated with subsequent cervical cytological ASC-US+ (hrHPV, lrHPV, UP, MH, TV, and MG) and HSIL (hrHPV, TV, and MG). Infection with lrHPV and MH could increase the CIN1 risk in future though no obvious CIN2+ risk elevation was observed.

BACKGROUND:Cytological samples are genotyped to inform clinical management of HPV-infected women due to their accessibility. Conversely, HPV genotypes identified in biopsies are deemed directly associated with cervical lesions. Thus, investigating genotyping agreement between these two sample types and potential influence of lesion severity and vaccination status on their degree of concordance is essential for understanding their diagnostic reliability. METHODS:Paired cervical cytological samples and formalin-fixed paraffin-embedded (FFPE) biopsies from 392 cervical intraepithelial neoplasia or cancer (CIN+) cases (187 CIN1, 111 CIN2, 94 CIN3+; 262 unvaccinated, 130 vaccinated) were genotyped using SPF10-DEIA-LiPA25 detection system. Strength of agreement was measured by kappa, with thresholds indicating varying levels of agreement. RESULTS:Overall, most HPV genotypes were more frequently detected in cytological samples, with seven genotypes showing statistical differences between sample types (HPV39, 51, 52, 53, 56, 58, 68/73). Multi-type infection was more prevalent in cytological samples (147 versus 76, PMcNemar's test<0.001), whereas single-type infection was more common in FFPE biopsies (233 versus 296, PMcNemar's test<0.001). Proportions of observed agreement for all genotypes detected exceeded 95% and Prevalence-And-Bias-Adjusted kappa values (range: 0.832 to 0.990) indicated "Strong" (threshold: 0.80 to 0.90) to "Almost Perfect" (threshold: above 0.90) agreement. Lesion severity and vaccination status had negligible impacts on genotyping agreement. CONCLUSIONS:In conclusion, HPV genotyping by cytological samples and FFPE biopsies performed equally well regardless of lesion severity and vaccination status, directly supporting reliable utility of cytological HPV genotyping for clinical decisions. However, impact of sample type needs to be considered when interpretating and utilizing multi-type and/or single-type infection for scientific research. TRIAL REGISTRATION:ClinicalTrials.gov (NCT00779766). Registered on the 23th of October 2008.

Persistent infection with high-risk human papillomavirus (HR-HPV) is a necessary cause of cervical cancer and its precancerous lesions. This study aimed to identify factors associated with HR-HPV persistence in Chinese women. This study is a population-based, nationwide, multi-center prospective cohort study initiated in 2017, and a total of 10,481 women undergoing cervical cancer screening were enrolled. A subset of 1,684 women who tested HR-HPV positive at baseline were included in the analysis. The results of their HPV testing at baseline and during three follow-up visits (2018–2020) were used to assess 1-, 2-, and 3-year HR-HPV persistence. Variables with statistically significant associations in univariate analyses, expressed as odds ratios (ORs) with 95

OBJECTIVES:This study evaluates the clinical performance of high-risk human papillomavirus (HR-HPV) testing, liquid-based cytology (LBC), and HR-HPV and LBC co-testing for detecting cervical intraepithelial neoplasia (CIN) in premenopausal and postmenopausal women. METHODS:A total of 6,085 premenopausal and 4,766 postmenopausal women were recruited for cervical cancer screening using LBC and HR-HPV testing. Following screening, colposcopy and biopsy for pathology were performed according to established protocols. We calculated the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and area under the curve (AUC) for detecting CIN2/3 or worse (CIN2/3+). RESULTS:The sensitivity of LBC for detecting CIN2+ was 73.4% (95% CI=60.7%-83.3%) in premenopausal women and 58.8% (95% CI=44.2%-72.1%) in postmenopausal women. In contrast, significantly higher sensitivities were observed for HR-HPV testing and HR-HPV and LBC co-testing, both of which showed sensitivities of 96.9% (95% CI=88.2%-99.5%) in premenopausal women and 98.0% (95% CI=88.2%-99.9%) in postmenopausal women. While HR-HPV and LBC co-testing demonstrated superior specificity compared with HR-HPV testing alone [95.8% (95% CI=95.2%-96.3%) vs. 86.3% (95% CI=85.4%-87.1%) in premenopausal women; 93.7% (95% CI=92.9%-94.3%) vs. 80.6% (95% CI=79.5%-81.7%) in postmenopausal women], it also exhibited the highest PPV for CIN2+ prediction [19.6% (95% CI=15.4%-24.4%) in premenopausal women; 14.5% (95% CI=10.9%-18.6%) in postmenopausal women] compared with LBC or HR-HPV testing alone. CONCLUSIONS:HR-HPV and LBC co-testing demonstrates comparable high clinical accuracy for detecting CIN2+ in both premenopausal and postmenopausal women, with a preference for its use in postmenopausal screening.

Objectives The aim of the study was to evaluate the clinical performance of HBRT-H14, a real-time PCR-based assay that separates human papillomavirus (HPV) 16 and HPV18 from 12 other high-risk (HR) HPV types, in population according to Chinese guideline. Methods A total of 9829 eligible women aged 21-64 years from Henan, Shanxi, and Guangdong provinces were performed by HBRT-H14 testing and liquid-based cytology (LBC) screening at baseline and followed up for 3-year. The sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value of LBC diagnosis and HPV testing were calculated for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions. Results At baseline, 80 (0.81%) participants were diagnosed with CIN2+. HR-HPV with reflex LBC had a significantly higher sensitivity (78/80, 97.50% [95% CI, 91.34-99.31%] vs. 62/80, 77.50% [67.21-85.27%], McNemar's test p < 0.001), and a slightly lower specificity (8528/9749, 87.48% [86.80-88.12%] vs. 8900/9749, 91.29% [90.72-91.83%], McNemar's test p < 0.001) than LBC with reflex HR-HPV for CIN2+. 7832 (79.6%) participants completed 3-year follow-up and 172 (2.20%) participants were cumulatively diagnosed with CIN2+. Compared with LBC with reflex HR-HPV, HR-HPV with reflex LBC significantly increased the sensitivity (161/172, 93.60% [88.91-96.39%] vs. 87/172, 50.58% [43.18-57.96%], McNemar's test p < 0.001), but marginally decreased the specificity (6776/7660, 88.46% [87.72-89.16%] vs. 6933/7660, 90.51% [89.83-91.15], McNemar's test p < 0.001). In addition, the absolute 3-year risk of CIN2+ in HPV16/18-positive individuals was as high as 33% (80/238), whereas the risk in the HPV-negative population was only 0.16% (11/6787), much lower than those in the negative for intraepithelial lesion or malignancy population (1.21%, 85/7018). Moreover, similar results were found in women >= 30 years old. Discussion The study has indicated that HBRT-14 has a reliable clinical performance for use in cervical screening. The validated HPV test would improve the quality of population screening. (c) 2024 Published by Elsevier Ltd on behalf of European Society of Clinical Microbiology and Infectious Diseases.