Clinical evaluation of HPV DNA test combined with liquid-based cytology in the diagnosis of cervical disease

Objectives: To evaluate the sensitivity and accuracy of the HPV DNA test in conjunction with thin prep cytology test as a screening method of human papillomavirus (HPV) infection. To study either the cervical erosion is related to high risk HPV infection or to determine the mean age distribution that is more prone to HPV infection. Material and Methods: The study is a retrospective cohort implemented to determine the real performance of liquid based medium and HPV DNA testing combined in second clinical hospital of Jilin University Changchun, China. The study group included total 150 patients from January 1, 2011 to December 30, 2012. A computerized search identified patients with thin prep test results and high risk HPV DNA testing during a 2-year period was recruited. The patients were chosen after proper speculum examination followed by thin prep cytology (TCT) and HPV DNA test. Cytologic specimens were obtained with endocervical brush, which was rinsed into the vial of Cytyc. The residual samples after the cytology report were taken for reflex HPV DNA test. The manufacture protocol was followed for HPV DNA testing using Hybrid Capture II. Colposcopic biopsy was performed for the diagnosis purpose, in patients who had atypical squamous cells of undeter-mined significance (AUS-US), low grade intraepithelial lesion (LSIL) or high-grade intraepithelial lesion (HSIL) in cytology and with positive results of highrisk HPV DNA. The diagnostic criteria were based on the Bethesda System (TBS). Findings: The high risk HPV positive women with abnormal cytology had a CIN I risk of 73 (86%), whereas 35 (23.3%) high-risk HPV positive women out of 109 (72.7%) normal cytology who underwent histological biopsy had CIN I 16 (10.7%). The risk for cervical intraepithelial neoplasia (CIN) in women with high-risk HPV positive with normal cytology was higher among women invited for the first time 31 - 40 years of age 12 (8%) than among older women 1 (0.7%). Out of 44 (29.3%) women who had I degree erosion with 6 (14%) positive HPV DNA test 38 (86%) had a normal histology biopsy showing no statically significant between them. Conclusion: The data confirm that HR-HPV DNA testing is much more sensitive than cytology alone and that HPV DNA testing helps in identifying women with high risk of serious cervical disease in an efficient and medically acceptable manner. The other most significant advantage of this cervical cancer screening method is that women who are HPV DNA positive can easily and quickly referred for colposcopic examination (within one year), which could identify the precancerous and cancer stage. And those who are HPV DNA negative can safely have much longer screening intervals saving considerable costs. With mean age being 38 ± 10 years, age older than 30 years should undergo HPV DNA testing with cytology triage in primary screening. But in woman younger than 30 years using HPV DNA assay, as an initial screening step can increase the prevalence of abnormal smears and the positive predictive value of HPV followed by TCT. However, close follow-up is essential if the initial biopsy is negative because a considerable number of women may have HPV infection positive in subsequent studies.

Effectiveness of Co-Testing in Cervical Cancer Screening Program in Macao SAR

Background: Cervical cancer remains a significant public health concern in Macao SAR despite the implementation of a cervical cancer screening program and HPV vaccination. To improve early detection, Macao SAR introduced HPV DNA testing alongside cytology (co-testing) as the primary screening method in 2019. This study evaluates the effectiveness of co-testing in identifying cervical precancerous lesions (CIN2+) compared to cytology alone. Methods: We conducted a retrospective analysis of women aged 30 - 65 years who participated in the routine cervical cancer screening program in Macao SAR Primary Healthcare Centers from 2019 to 2022. Data from over 70,000 women were analyzed, comparing the detection rates of CIN2+ through co-testing and cytology alone. Women with abnormal cytology or positive HPV results were referred for colposcopy. Results: The introduction of co-testing led to a significant increase in the detection of CIN2+, particularly in women with atypical squamous cells of undetermined significance (ASCUS) or negative for intraepithelial lesion or malignancy (NILM) cytology results. Between 2019 and 2022, the percentage of women with ASCUS/NILM and any high-risk HPV (hrHPV) positive who were diagnosed with CIN2+ after colposcopy were 24%, 13%, 10% and 7.5% respectively. This highlights the ability of co-testing to identify high-risk individuals who would have been missed by cytology alone. Discussion: Our findings demonstrate the effectiveness of co-testing in improving the sensitivity of cervical cancer screening in Macao SAR. The inclusion of HPV DNA testing allows for better risk stratification of women with ASCUS/NILM cytology, leading to more targeted referrals for colposcopy and timely detection of precancerous lesions. The initial high positive rate in 2019 (24%) might be attributed to the small sample size and potentially reflects a backlog of undiagnosed cases prior to co-testing implementation. Conclusion: The implementation of co-testing in Macao SAR’s cervical cancer screening program significantly improves the early detection of precancerous lesions, particularly in women with ambiguous cytology results. This proactive approach contributes to reducing cervical cancer morbidity and mortality and improving women’s health outcomes in Macao SAR.

Vaginal Intraepithelial Neoplasia Detected with Cervical Liquid-Based Cytology: Old Concerns or New Facilities?

Background: The detection of vaginal intraepithelial neoplasia (VAIN) in cervical samples is not a common finding. Therefore, we aimed to report VAINs detected in liquid-based cytology (LBC) from women examined at Hospital das Clínicas of Faculty of Medicine, Sao Paulo State University. Materials and Methods: We evaluated LBC samples from women referred to gynecology examination for different reasons (previous abnormal PapTest, follow up of treated cervical lesion, ecc) and women examined for regular screening proposals, and compared with biopsy diagnoses, including the controversial diagnoses of vaginal intraepithelial neoplasia (VAIN). Results: From 1866 patients, 1423 (76.3%) cases were negative and 443 (23.7%) were positive for any cellular alteration. Age of patients ranged from 12 to 86 years. We detected 25 histologically confirmed VAIN (1.3% p = 0.0002 by Fisher’s exact test IC 95% 0.0090 - 0.0198) and 1.1% VAIN (p = 0.0031 by Fisher’s exact test IC 95% 0.0077 - 0.0179). Conclusion: The identification of VAIN in routine is feasible;the professionals involved with cytological examination should be aware of these lesions in Pap test samples.

New cheaper human papilloma virus mass screening strategy reduces cervical cancer incidence in Changsha city:A clinical trial

BACKGROUND Cervical cancer is the second leading cause of death in women worldwide,second only to breast cancer.Around 80%of women have been infected with human papillomavirus(HPV)in their lifetime.Early screening and treatment are effective means of preventing cervical cancer,but due to economic reasons,many parts of the world do not have free screening programs to protect women’s health.AIM To increase HPV cervical cancer screening in Changsha and reduce the incidence of cervical cancer.METHODS Cervical cancer screening included gynecological examination,vaginal secretion examination and HPV high-risk typing testing.Cervical cytology examination(ThinPrep cytology test)was performed for individuals who test positive for HPV types other than 16 and 18.Vaginal colposcopy examination was performed for HPV16 and 18 positive individuals,as well as for those who were positive for ThinPrep cytology test.If the results of vaginal colposcopy examination were abnormal,histopathological examination was performed.We conducted a cost-benefit analysis after 4 years.RESULTS From 2019 to 2022,523437 women aged 35-64 years in Changsha city were screened and 73313 were positive,with a 14%positive rate.The detection rate of precancerous lesions of cervical cancer was 0.6%and the detection rate of cervical cancer was 0.037%.Among 311212 patients who underwent two cancers examinations,the incidence rate was reduced by more than half in the second examination.The average screening cost per woman was 120 RMB.The average cost of detecting early cases was 10619 RMB,with an early detection cost coefficient of 0.083.CONCLUSION Our screening strategy was effective and cost-effective,making it valuable for early diagnosis and treatment of cervical cancer.It is worth promoting in economically limited areas.

p16/Ki-67 dual-stained cytology used for triage in cervical cancer opportunistic screening

Objective:To evaluate the efficiency of p16/Ki-67 dual stain used as a triage in cervical cancer screening.Methods:In this study,we did 468 p16/Ki-67 dual stain in human papillomavirus(HPV)16/18-positive or 12 other high-risk HPV(OHR-HPV)positive Thinprep cytologic test(TCT)atypical squamous cells of undetermined significance(ASCUS)/lower-grade squamous intraepithelial lesion(LSIL)women.We evaluated the sensitivity,specificity,positive predictive value(PPV)and negative predictive value(NPV)of the triage test.Results:The sensitivity,specificity,PPV and NPV of p16/Ki-67 dual stain in HPV 16/18-positive women were91.5%/68.4%,77.0%/75.0%,73.9%/59.1%and 92.8%/81.8%.In 12 OHR-HPV positive TCT ASCUS/LSIL women,the results were 79.1%/95.0%,88.5%/66.7%,88.5%/70.4%and 89.2%/94.1%.The risk of precancerous lesions in p16/Ki-67 dual stain positive cases was much higher than before,and the negative cases had lower risk.Besides,there was no cervical intraepithelial neoplasia(CIN)III case missed after triaged by p16/Ki-67 dual-stained cytology.In p16/Ki-67 dual-stained cytology positive women with benign pathology or CIN I,the 1-year progression rate is 20.5%and in p16/Ki-67 dual-stained cytology negative women,the 1-year progression rate is5.6%.Conclusions:hr-HPV genotyping test plays an important role in cervical cancer screening.p16/Ki-67 dual stain may be a promising triage test.As for chronic cervicitis or CIN I patients,a positive p16/Ki-67 dual-stained cytology suggests a high risk in progression and need to be followed up closely.

Research of cervical cytology screening in diagnosis of 370,000 cases with cervical lesion in Guangdong

Objective： Analysis of the results of 37 million cases by using cervical liquid-based cytology screening, discussion the situation of cervical cancer and precancerous lesions in Guangdong province. Methods： From 2002 to 2006, using liquid-based thin-layer cytology （TCT） method screening cervical lesions within 371,929 women in Guangdong. Cytological diagnosis adopt TBS （the Bethesda system） Standard （TBS improved 2001 version of the diagnostic criteria）, statistic positive rate by age and region respectively. Results： 371,929 cases of gynecology cervical samples in Guangdong, 331,251 cases were negative, accounted for 91.23%; cytology positive cases： 32,548 cases were squamous intraepithelial lesions （8.96%）, 486 cases were glandular epithelial lesions （0.13%）; grouped according to age： 30 to 40-year-old positive rate was 9.13%, 40 to 50-year-old positive rate was 9.60%, the latter had higher cytology positive rate; grouped according to region： the total samples in PRD areas were 304.951 cases, accounted for 81.99%, in which 24301 cases were positive （8.14%）, in 66978 cases （18.01%） of NON-PRD regions, 7645 cases were positive （11.87%）, there were 1858 cases had biopsy/follow-up results from 2004 to 2005, and the rate was 2.88%. Conclusion： The cytological positive rate of cervical cancer and its precancerous lesions was 9.09% in Guangdong （of which the rate of cytological diagnosis as precancerous lesions was 3.40%）, 30 to 50 age group had the high incidence of cervical cancer and its precursor lesions, and also the main stage of prevention for cervical cancer. Cytology positive rate was 11.87% in economic underdevelopment Non-Pearl River Delta regions, much higher than the Pearl River Delta region.

Correlative analysis between abnormal cervical cytology and pathology of vaginoscopic biopsy or conization

Objectives: To evaluate the predictive value of cervical intraepithelial neoplasia (CIN)III/ carcinoma in situ (CIS) by correlating analysis between abnormal cervical cytologic findings and pathological diagnosis of vaginoscopic biopsies or conization.Methods: Routine cervical cytology screening was performed in 31,634 cases by fluid-based thin-layer method (ThinPrep cytology test, TCT), 948 patients had both abnormal squamous cell appearance by TCT and pathological diagnosis of vaginoscopic biopsies and /or cervical conization. The predictive value of CINIII/CIS were studied retrospectively by correlating analysis of different cytology abnormalities and pathology diagnosis.Results: Cytologically, 1,260 out of 31,634 TCT tests showed abnormal squamous cells appearance, including atypical squamous cell of undetermined significance (ASCUS) 675 cases(2.13%), low squamous intraepithelial lesion (L-SIL) 379 cases(1.20%), high squamous intraepithelial lesion (H-SIL)176 cases(0.56%),cancer 30 cases (0.09%). Among 948 patients with pathological diagnosis, there were CINII-III in 70 cases(7.38%) and CINIII/CIS in 56 cases.(5.91%). The relative risks (RR) of different precancerous TCT results in predicting CIN III/CIS validated by pathology are as follow: AUSCUS 14.7% (95% confidence interval (CI) 8.0-27.0), Lsil 13.9% (95% CI 6.3-30.9), Hsil 126.1 (95% CI 60.6-218.6). The RR of AUSCUS group is not significantly different from that of L-SIL group(P =0.951). However, the RR of CINⅢ/CIS morbidity between the H-SIL or cancer group and the ASCUS or L-SIL group are significantly different (all P value <0.01).Conclusion: Vaginoscopic biopsy could verify pathological CINⅡ-Ⅲ and CINⅢ/CIS from cases with abnormal TCT results. There is significantly greater risk of being CINⅢ/CIS validated by vaginoscopic biopsy in the H-SILpatients,while ASCUS and L-SIL group have the coequal risk.

Concordance in the Interpretation of Cervical Cytology for the Early Diagnosis of Cervical Cancer

Objective: To identify the diagnostic concordance in the interpretation of cervical smears. Material and Methods: Cross-sectional study from October 2011 to January 2013. 50 samples were read by every 4 cyto-technologists who are the total staffs that read and interpret cytological specimens from a public health institution of the city of San Luis Potosí, México. The cytological diagnosis was confirmed by a certified pathologist. Checklist was developed to determine the quality of the interpretation composed of three sections: adequate sample, inadequate sample and cytological diagnosis. The diagnostic report was made by Bethesda System 2001 classification. Diagnostic concordance was measured through the Kappa coefficient. To establish the differences in cytological diagnosis between each cyto-technologist, chi square test was applied. Results: The concordance is acceptable in the classification of samples as inadequate (k = 0.66). The negative diagnosis was a significant concordance between each cytotechnologist and pathologist;however, no case had very good concordance. In the epithelial abnormalities, only the cytotechnologist 2 had significant concordance with the pathologist, however, its concordance is low. In the case of glandular abnormalities, only cytotechnologist 1 had no significant concordance with the pathologist. The percentage of true negatives was 30%, true positives 20%, false negatives 50% and false positives 0 %. There are significant differences between the readings of cyto-technologist 1 and 2 (p < 0.008), between 1 to 4 (p < 0.001), between 2 and 3 (p < 0.05), and finally between 3 and 4 (p < 0.003). Conclusions: The concordance between cyto-technologists and pathologists is below the required minimum level set by national and international standards.

Follow-up study on ThinPrep cytology test-positive patients in tropical regions

BACKGROUND As shown in the statistics from the World Health Organization,it is estimated that approximately 75000 new cases of cervical cancer occur every year in China.In 2008,33000 people died of cervical cancer in China.It is proven that most women are at risk of cervical cancer.The progression from human papillomavirus(HPV)infection to cervical cancer can be several years or decades,which offers a unique opportunity to prevent cancer.AIM To observe the changes in ThinPrep cytology tests(TCT)and HPV infection in patients who were detected to be positive via TCT screening of cervical cancer and further explore the biopsy results.METHODS This paper performed a follow-up study on 206 cervical cancer screening-positive patients of 12231 total cases from our previous research.We conducted an observational study on the TCT results based on the interpretation of The Bethesda System.RESULTS Over a 5-year period,10 cases received consistent follow-up.The proportions of cases in which glandular epithelial lesions were detected increased over the follow-up period.The differences between the years were statistically significant(P<0.01).Over the 5 years,the proportion of patients whose squamous epithelial lesions transformed into glandular epithelial lesions increased yearly.Annual positive rates of HPV infection were:year 1,73%(24/33);year 2,43%(6/14);year 3,36%(9/25);year 4,50%(9/18);and year 5,25%(6/24).The positive detection rate after biopsy over a 9-year period was 29%.CONCLUSION The follow-up study for 5 years to 9 years revealed a tendency to change from squamous epithelial lesions to glandular epithelial lesions and an improvement of the disease(which had not been reported previously).The HPV test indicated a high negative conversion ratio of the viral infection.However,the follow-up cases were not found to have persistent infection of high-risk HPV.Therefore,early intervention of cervical cancer screening is necessary.Low re-examination compliance,patient education,and preventive measures should be enhanced.

A study on service capacity of primary medical and health institutions for cervical cancer screening in urban and rural areas in China

Objective: To provide a decision-making basis for sustainable and effective development of cervical cancer screening.Methods: This cross-sectional study assesses the service capacity to conduct cervical cancer screening with a sample of 310 medical staff, medical institutions and affiliated township health centers from 20 countylevel/district-level areas in 14 Chinese provinces in 2016.Results: The county-level/district-level institutions were the main prescreening institutions for cervical cancer screening. More medical staff have become engaged in screening, with a significantly higher amounts in urban than in rural areas(P<0.05). The number of human papillomavirus(HPV) testers grew the fastest(by 225% in urban and 125% in rural areas) over the course of the project. HPV testing took less time than cytology to complete the same number of screening tasks in both urban and rural areas. The proportion of mid-level professionals was the highest among the medical staff, 40.0% in urban and 44.7% in rural areas(P=0.406), and most medical staff had a Bachelor’s degree, accounting for 76.3% in urban and 52.0% in rural areas(P<0.001). In urban areas, 75.0% were qualified medical staff, compared with 68.0% in rural areas, among which the lowest proportion was observed for rural cytology inspectors(22.7%). The medical equipment for cervical pathology diagnosis in urban areas was better(P<0.001). HPV testing equipment was relatively adequate(typing test equipment was 70% in urban areas, and non-typing testing equipment was 70% in rural areas).Conclusions: The service capacity of cervical cancer screening is insufficient for the health needs of the Chinese population. HPV testing might be an optimal choice to fill the needs of cervical cancer screening given current Chinese medical health service capacity.

HPV E6/E7 mRNA联合细胞学检查用于子宫颈癌早期筛查的初步评价

目的探讨人乳头瘤病毒(HPV)E6/E7 mRNA联合液基薄层细胞学检查(TCT)用于宫颈癌早期筛查的初步评价。方法收集2015年10月—2019年7月在本院进行宫颈癌筛查患者825例,均进行HPV E6/E7 mRNA、TCT检测,以组织病理学为金标准,分析HPV E6/E7 mRNA与TCT联合检测用于评估患者宫颈病变风险的诊断效能。结果HPV E6/E7 mRNA检测和TCT检测不同病理分级患者宫颈慢性炎、低级别鳞状上皮内病变(LSIL)、高级别鳞状上皮内病变(HSIL)、宫颈癌的阳性率分别为12.17%、39.04%、86.61%、87.88%和36.51%、82.89%、82.14%、81.82%。HPV E6/E7 mRNA检测的敏感性为86.90%,特异性为80.44%,准确性为81.58%。TCT检测的敏感性为82.07%,特异性为50.74%,准确性为56.24%。HPV E6/E7 mRNA联合TCT检测的敏感性为70.34%,特异性为83.68%,准确性为81.33%。HPV E6/E7 mRNA与TCT联合检测特异性高于单一检测,差异有统计学意义(P<0.001)。HPV E6/E7 mRNA与TCT两种检测方法的受试者工作特征曲线(ROC)曲线下面积(AUC)分别为0.837和0.664,两者联合检测的AUC为0.860,差异性显著(P<0.001),提示联合诊断可提高诊断宫颈HSIL的性能。结论HPV E6/E7 mRNA联合TCT能够更好预测宫颈病变的进展,且针对高级别病变的筛查具有更高的特异性,可为临床宫颈癌筛查提供参考。

2016—2022年某精神病专科医院1181名女职工宫颈液基薄层细胞技术和人乳头状瘤病毒感染调查

目的分析精神病专科医院1181名女职工宫颈液基细胞学检查(TCT)和人乳头瘤病毒(HPV)的感染状况。方法选取精神病专科医院2016年1月至2022年12月在职的1181名女职工作为研究对象,所有人均行TCT与HPV检查,根据检查结果分析感染情况。结果1181名女职工HPV检测总阳性率为4.91%(58/1181),其中<30岁及40~50岁两个年龄段总阳性率高于其他年龄段(P<0.05)。TCT检测报告异常率为5.42%(64/1181),其中<30岁及40~50岁两个年龄段TCT检查总异常率高于其他年龄段(P<0.05)。初次性生活年龄<16岁女职工相较于初次性生活为其他年龄段女职工高危型HPV、低危型HPV、TCT异常的阳性率更高(P<0.05)。宫颈癌发病率逐年升高,且2021、2022年两个年份TCT与HPV阳性检出率相较于其他年份更高(P<0.05)。TCT分级中,高级别鳞状上皮内病变的高危型HPV阳性检出率高于低级别鳞状上皮内病变和非典型鳞状上皮细胞增生,非典型鳞状上皮细胞增生的HPV阴性率高于低级别鳞状上皮内病变和高级别鳞状上皮内病变(均P<0.05)。结论<30岁、41~50岁两个年龄段以及初次性生活年龄<16岁精神病专科医院女职工为易感人群,应加强对该部分女职工宫颈癌的防治工作,且宫颈癌发病率逐年升高,医院应更加重视医院女职工的宫颈癌预防健康宣教工作。

液基细胞学检查结合人乳头瘤病毒检测在绝经后女性宫颈癌机会性筛查中的应用价值

目的探讨液基细胞学检查(TCT)结合人乳头瘤病毒(HPV)检测在绝经后女性宫颈癌机会性筛查中的应用价值。方法选取2022年6月至2023年6月在吉林医药学院附属医院妇科门诊接受诊治的1022例绝经后妇女为研究对象,分别进行TCT、阴道镜组织检查和HPV检查,以阴道镜组织检查为金标准,采用ROC分析评价TCT、HPV与二者联合对绝经后宫颈癌的诊断效能。结果1022份TCT检测样本中,TCT结果为正常或炎症反应919例(89.9%),而TCT检查异常者103例(10.1%)。阴道细胞学的分类及报告系统(TBS)报告为非典型鳞状上皮细胞(ASC-US)53例(51.5%),低度鳞状上皮内瘤变(LSIL)23例(22.3%),高度鳞状上皮内瘤变(HSIL)21例(20.4%),鳞状细胞癌(SCC)6例(5.8%)。阴道镜组织病理结果显示,炎症反应34例(33.0%),上皮内瘤变(CIN)Ⅰ37例(35.9%);CINⅡ16例(15.5%);CINⅢ11例(10.7%),SCC 5例(4.9%)。TCT检查异常者中有69例(66.9%)为阴道镜检查异常,TCT结果与病理学结果总体符合率为56.3%(58/103)。随着TBS分类级别越高,HPV阳性率越高,HSIL组和SCC组的HPV阳性率高于LSIL组和ASC-US组,差异有统计学意义(P<0.05)。ROC分析结果显示,TCT诊断的AUC高于HPV,为0.785(95%CI:0.694~0.895),敏感度较高的是TCT检查,但是特异度较高的是HPV检测。二者联合诊断的AUC进一步提高,为0.813(95%CI:0.723~0.924),敏感度和特异度分别是84.3%和88.5%。结论HPV检查结合TCT检查在绝经后女性宫颈癌机会性筛查中具有重要应用价值,建议临床加以推广。

人乳头瘤病毒E6/E7 mRNA检测在宫颈癌筛查中的应用价值

目的探讨人乳头瘤病毒(HPV)E6/E7 mRNA检测在宫颈癌筛查中的应用价值。方法选取2000例接受宫颈癌筛查的女性,均接受液基薄层细胞学检查(TCT)和HPV E6/E7 mRNA检测,以阴道镜病理活检结果作为金标准,评估TCT、HPV E6/E7 mRNA定性、HPV E6/E7 mRNA定量单独及联合检测对宫颈癌的诊断价值。结果2000例筛查女性中,正常或炎症1917例,低级别鳞状上皮内病变(LSIL)60例,高级别鳞状上皮内病变(HSIL)14例,宫颈癌9例。TCT检测结果显示,无上皮内瘤变或恶性病变(NILM)1753例,未明确意义的非典型鳞状上皮细胞(ASCUS)/非典型腺细胞(AGC)168例,LSIL 57例,HSIL 13例,宫颈癌9例。HPV E6/E7 mRNA检测结果显示,阳性178例,阴性1822例,随着组织学严重程度的增加,HPV E6/E7 mRNA检测的病毒拷贝数逐渐增加。受试者工作特征(ROC)曲线显示,TCT、HPV E6/E7 mRNA定性、HPV E6/E7 mRNA定量联合检测诊断宫颈癌的曲线下面积(AUC)为0.896(95%CI:0.882~0.909),此时的灵敏度为0.880,特异度为0.836。结论HPV E6/E7 mRNA检测作为宫颈癌初筛方案具有一定的可行性,TCT、HPV E6/E7 mRNA定性、HPV E6/E7 mRNA定量联合检测在宫颈癌筛查中有较高的价值。

人乳头瘤病毒DNA、E6/E7 mRNA及液基薄层细胞学检查对女性宫颈癌的筛查价值

目的探讨人乳头瘤病毒(HPV)DNA、E6/E7 mRNA及液基薄层细胞学检查(TCT)对女性宫颈癌的筛查价值。方法选取28021例体检女性,均接受HPV DNA、E6/E7 mRNA和TCT单项或多项检测,记录HPV DNA、E6/E7 mRNA、TCT单独及联合检测对宫颈癌的检出情况。以组织活检结果为金标准,评估HPV DNA、E6/E7 mRNA、TCT单独或联合检测对宫颈癌的筛查价值。结果TCT、HPV DNA、E6/E7 mRNA对宫颈癌的检出率分别为8.8%、26.9%、29.7%。各方法单独检测时,TCT单独检测筛查宫颈癌的特异度最高(85.53%),但灵敏度最低(28.44%),HPV DNA单独检测筛查宫颈癌的灵敏度最高(60.25%)。两种方法联合检测时,HPV DNA+E6/E7 mRNA联合检测筛查宫颈癌的灵敏度最高(81.75%),特异度最低(26.34%),TCT+HPV DNA联合检测筛查宫颈癌的特异度(61.08%)和阴性预测值(57.11%)最高,任意两种方法联合检测筛查宫颈癌的灵敏度、特异度比较,差异均有统计学意义(P﹤0.05)。TCT+HPV DNA+E6/E7 mRNA联合检测筛查宫颈癌的灵敏度、特异度与HPV DNA+E6/E7 mRNA检测比较,差异均无统计学意义(P﹥0.05),但灵敏度高于TCT+E6/E7 mRNA联合检测,特异度低于TCT+E6/E7 mRNA联合检测,差异均有统计学意义(P﹤0.05)。结论HPV DNA检测适合作为女性健康体检者宫颈癌筛查的首选方法,E6/E7 mRNA与TCT检测可作为宫颈癌进一步检查的优选。HPV DNA+E6/E7 mRNA联合检测具有较高的灵敏度和阳性预测值,可作为年轻女性宫颈癌筛查的优选方案,联合检测对提高阳性率及降低假阳性率有帮助。

HPV检测联合液基薄层细胞学检测宫颈癌的诊断价值分析

目的 研究液基薄层细胞学(Thinprep-Cytologic Test, TCT)检测联合人乳头瘤病者(Human Papillomavirus, HPV)检测对宫颈癌的诊断价值。方法 选取2022年1月—2023年10月淄博市妇幼保健院新院区检验科的100例疑似宫颈癌前病变患者为研究对象,均实施HPV检测、TCT以及联合检测,以阴道镜下取宫颈活检病理诊断结果为金标准,分析上述单一及联合检测的阳性率以及诊断价值。结果 100例受检者中,HPV检查阳性检出率为20.00%,TCT阳性检出率为27.00%,TCT+HPV阳性检出率为35.00%;TCT+HPV的准确度(96.00%)、灵敏度(91.89%)高于TCT和HPV,差异有统计学意义(χ^(2)=8.000、15.457、7.974、18.231,P均<0.05)。结论 TCT+HPV具有较高的特异度、灵敏度及准确度,在宫颈癌诊断中具有积极意义。

PAX1甲基化与p16/Ki-67联合检测提高宫颈癌非典型鳞状细胞的诊断效能

目的 比较配对盒家族基因1(paired boxed gene 1,PAXl)甲基化与p16/Ki-67双染单独及联合检测在薄层液基细胞学检查(thinprep cytologic test, TCT)为意义不明的非典型鳞状细胞(atypical squamous cells of undetermined significance, ASC-US)及低级别鳞状上皮内病变(low-grade squamous intraepithelial lesion, LSIL)人群中的诊断效能。方法 选择郑州大学第一附属医院2021-2022年247例TCT结果为ASC-US和LSIL患者,以阴道镜下病理结果为金标准,敏感度、特异性、准确度与ROC曲线下面积(area under the subject curve, AUC)为评价指标,比较PAX1甲基化和p16/Ki-67双染单独及联合检测的检验效能。结果 PAX1甲基化与p16/Ki-67双染的阳性率随着阴道镜下病理结果的严重程度而增加,PAX1甲基化和p16/Ki-67联合检测在TCT为ASC-US人群中的敏感度为91.25%、特异度为97.72%、准确度为95.51%,优于甲基化、p16/Ki-67双染单独检测,差异有统计学意义(P<0.01)。结论 PAX1甲基化和p16/Ki-67双染联合检测可以提高TCT结果为ASC-US患者的诊断效能。

宫颈癌筛查中TCT联合HPV的应用价值及与阴道感染关系

目的:探讨薄层液基细胞学(TCT)联合人乳头状瘤病毒(HPV)检测在宫颈癌筛查中的应用价值,分析宫颈癌与阴道感染的关系。方法:收集2022年7月-2023年7月本中心行宫颈病变筛查的483名女性临床资料,纳入对象均行TCT、HPV检测,依据病理诊断结果分为非宫颈癌组(n=467)和宫颈癌(n=16),受试者工作特征曲线(ROC)分析TCT、HPV检测筛查宫颈癌价值;比较两组阴道感染率、阴道微生态情况。结果:以病理结果为依据,诊断宫颈癌TCT检测准确率为92.3%,HPV检测准确率为92.6%,2项联合检测准确率为98.1%;ROC分析,2项联合检测诊断宫颈癌的曲线下面积(0.953)高于TCT(0.777)、HPV(0.808),联合检测诊断特异度(96.8%)和敏感度(93.8%)更高(P<0.05);宫颈癌组阴道感染率(93.8%)高于非宫颈癌组(29.1%),过氧化氢(56.3%)、乳杆菌(50.0%)阳性率高于非宫颈癌组(31,1%、21.0%),唾液酸苷酶(6.3%)、白细胞酯酶(43.8%)阳性率低于非宫颈癌组(28.9%、75.4%)(均P<0.05)。结论:TCT联合HPV检测筛查宫颈癌价值较高,宫颈癌患者阴道感染率升高,阴道微生态发生变化,临床需多加关注。

TCT结合HR-HPV基因检测对宫颈癌及癌前病变筛查的临床意义

目的探讨液基细胞学(TCT)与高危型人乳头瘤病毒(HR-HPV)基因联合检测对宫颈癌及癌前病变筛查的临床意义。方法选取2020年1月至2022年12月于临夏州人民医院妇科门诊筛查宫颈病变者6762例,所有受检者同时行TCT、HR-HPV基因检测,对TCT和(或)HR-HPV基因检测结果阳性者行阴道镜和组织病理学检查,并以此为诊断标准,对比分析TCT、HR-HPV基因检测单独和联合检测在宫颈癌及癌前病变筛查中的诊断价值。结果6762例受检者中TCT检查和HR-HPV基因检测阳性分别有705例(10.43%)和884例(13.07%)。对1289例TCT和(或)HR-HPV基因检测阳性者行阴道镜和组织病理学检查,共检出阳性838例,占65.01%,其中CIN1占53.94%,CIN2占21.48%,CIN3占15.39%,宫颈癌占9.19%。以组织病理学结果为诊断金标准,TCT检查、HR-HPV基因检测以及TCT+HR-HPV基因检测的病理阳性率分别为40.65%、49.50%、54.38%,TCT+HR-HPV基因检测的病理阳性率显著高于单独TCT检查和HR-HPV基因检测,差异有统计学意义(χ^(2)=48.730、6.168,P<0.05)。TCT检查联合HR-HPV基因检测方法筛查宫颈癌及癌前病变的灵敏度为83.65%,准确率为84.54%,均高于TCT检查的64.68%、70.75%和HR-HPV基因检测的76.13%、78.28%(χ^(2)=79.550、41.259、15.145、4.262,P<0.05)。结论TCT与HR-HPV基因检测联合可提高宫颈癌及癌前病变的早期检出率。

HPV DNA、HPV E6/E7蛋白和TCT在宫颈上皮内瘤变及宫颈癌筛查中的价值

目的 探讨人乳头瘤病毒(human papilloma virus,HPV)DNA、HPV E6/E7蛋白和液基薄层细胞学检查(thin-prep cytology test,TCT)在宫颈上皮内瘤变(cervical intraepithelial neoplasia,CIN)及宫颈癌筛查中的价值。方法 选取2021年7月至2022年6月于诸暨市人民医院妇科接受早期宫颈癌筛查的成年女性190例为研究对象,分别进行HPV DNA、HPVE6/E7蛋白及TCT检测,并进一步行阴道镜活检检查。比较不同病变患者的HPVDNA、HPVE6/E7蛋白和TCT对高级别病变的诊断效能。结果 CIN3及宫颈癌患者的HPV DNA、HPV E6/E7蛋白、TCT检查及三者联合检测的阳性率均显著高于宫颈炎患者(P<0.05),宫颈癌患者的HPV DNA、HPV E6/E7蛋白、TCT检查及三者联合检测的阳性率均显著高于CIN1患者(P<0.05)。CIN2+患者的HPV DNA、HPV E6/E7蛋白、TCT及三者联合检测的阳性率显著高于CIN1-患者。HPVDNA、HPVE6/E7蛋白、TCT三者联合诊断高级别病变的敏感度、特异性、阳性预测值和阴性预测值分别为90.80%、30.10%、52.32%、79.48%。结论 HPV DNA、HPV E6/E7蛋白及TCT可作为筛查宫颈癌和癌前病变的手段,且三者联合检测的敏感度最高。