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 ...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.展开更多
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 introdu...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.展开更多
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 ...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.展开更多
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 h...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.展开更多
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 v...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.展开更多
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-technolog...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.展开更多
文摘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.
文摘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.
基金Supported by the Hainan Provincial Natural Science Foundation of China,No.822RC870 and No.819MS148.
文摘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.
文摘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.
文摘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.
文摘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.
