Since 1998,Preventive Oncology International,Inc.(POI)has been at the forefront of studying human papillomavirus(HPV)self-collection for cervical cancer screening,with a significant focus in China.Through multiple cli...Since 1998,Preventive Oncology International,Inc.(POI)has been at the forefront of studying human papillomavirus(HPV)self-collection for cervical cancer screening,with a significant focus in China.Through multiple clinical trials over the past 25 years,POI has explored various aspects related to self-collection methodologies.In 2004–2006,POI established that self-collection could be equivalent to direct endocervical samples.Subsequently,a large randomized trial involving 10,000 patients in 2010 further confirmed that self-collected vaginal specimens,tested for high-risk HPV(hrHPV)using a PCR-based assay with high analytic sensitivity,could effectively replace endocervical specimens with minimal loss of sensitivity and a slight decrease in specificity.Throughout the years,POI's research has encompassed several crucial topics,including patient acceptance,the development of new cost-effective,simpler,and faster assays,exploring different collection devices,devising efficient methods of specimen transport,and implementing population-based screening systems.The findings strongly support the integration of self-collection methodologies into cervical cancer control programs worldwide,particularly in medically underserved regions.As HPV self-collection continues to evolve,ongoing research and innovations are expected to play a pivotal role in achieving the global mission of combating cervical cancer.展开更多
Background: Community based cervical cancer screening models using self-collection can effectively place the identification of who is positive in the hands of the patient. The key areas we have identified as critical ...Background: Community based cervical cancer screening models using self-collection can effectively place the identification of who is positive in the hands of the patient. The key areas we have identified as critical are 1) education, 2) notification of screening opportunities, 3) registration, 4) submission of samples, 5) receiving results with an explanation, and 6) being advised where to receive evaluation and management from qualified healthcare personnel. Methods: Our primary objectives were to create, register, and pilot a website as a public platform for cervical cancer prevention for both city and rural, individual and organizational application. We selected two sites: Shenzhen City in China as the local city (individual participant) site, and Sangzhi County in Hunan Province as the remote (group management) site. The website was reviewable to all of China, but applications for screening and registration were open only to the women from the 2 pilot sites. In the local site, the women would first sign up (obtain a password) to view the website (www.mcareu.com), and then if they desired, they could register for screening using their true name and their state ID. After an offline confirmation of the address, the sampling kit would arrive. Results were available with additional education and guidance for care also on the website. Findings: 120,099 people nationwide visited the website in 27 months by the end of May, 2015, 1148 women from the sites registered at the website and 87.5% enrolled in the pilot trial. 72.3% of those testing positive returned for management. Virtually 100% of the registration/historical information was entered appropriately and 100% of the samples were handled properly. Interpretation: Web-based decision aids help patients through the uncertainties of healthcare. Applied to cervical cancer screening using self-collection, the effectiveness of the model specifically in respect to accessibility, education, registration, data input, and instructions for positive management was clearly demonstrated by this pilot as well as the potential for future diagnostics applicable to self-collection.展开更多
Background:Dry specimen transport has shown equivalence to traditional liquid transport using a novel high-risk Human papillomavirus assay.Considering that dry transport might cross obstacles during cervical cancer sc...Background:Dry specimen transport has shown equivalence to traditional liquid transport using a novel high-risk Human papillomavirus assay.Considering that dry transport might cross obstacles during cervical cancer screening in low and middle resource settings,this study was designed evaluate different processing time of dry specimen transport using the same isothermal amplification hrHPV assay.Methods:There were 564 women between the ages of 30–55 recruited from colposcopy clinic.For each patient,two endocervical samples were collected and placed into empty collection tubes by physician.Samples were stored at room temperature until analyzed for hrHPV using the AmpFire assay at two time points:2 days and 2 weeks.511 of the 564 participants with positive hrHPV were provided colposcopy exam and quadrant biopsy.Results:A total of 1128 endocervical samples from 564 patients were detected by the Ampfire assay.Good agreement was found between two time periods(KappaStandard error=0.67±0.04).Sensitivity(2days/2weeks)for CIN2t was 95.28%(95%CI:92.14%–98.42%)vs 90.57%(CI(86.65%–94.49%)and specificity(2days/2weeks)was 22.47%(CI 19.33%–25.61%)vs 28.15%(CI 24.23%–32.07%)respectively.The difference for Ampfire HPV detection in sensitivity for CIN2t for the two time periods was not significant(P=0.227),while the difference in specificity for CIN2t was significant(P=0.001).The difference in Ct values 29.23(CI 28.15–30.31)and 29.27(CI 28.19–30.35)between two time points was not significant(P?0.164).Conclusion:Processing dry brush specimens can be delayed up to 2 weeks.Using the AmpFire assay platform which supports cervical cancer prevention programs in low-to-middle-income countries(LMICs).展开更多
文摘Since 1998,Preventive Oncology International,Inc.(POI)has been at the forefront of studying human papillomavirus(HPV)self-collection for cervical cancer screening,with a significant focus in China.Through multiple clinical trials over the past 25 years,POI has explored various aspects related to self-collection methodologies.In 2004–2006,POI established that self-collection could be equivalent to direct endocervical samples.Subsequently,a large randomized trial involving 10,000 patients in 2010 further confirmed that self-collected vaginal specimens,tested for high-risk HPV(hrHPV)using a PCR-based assay with high analytic sensitivity,could effectively replace endocervical specimens with minimal loss of sensitivity and a slight decrease in specificity.Throughout the years,POI's research has encompassed several crucial topics,including patient acceptance,the development of new cost-effective,simpler,and faster assays,exploring different collection devices,devising efficient methods of specimen transport,and implementing population-based screening systems.The findings strongly support the integration of self-collection methodologies into cervical cancer control programs worldwide,particularly in medically underserved regions.As HPV self-collection continues to evolve,ongoing research and innovations are expected to play a pivotal role in achieving the global mission of combating cervical cancer.
文摘Background: Community based cervical cancer screening models using self-collection can effectively place the identification of who is positive in the hands of the patient. The key areas we have identified as critical are 1) education, 2) notification of screening opportunities, 3) registration, 4) submission of samples, 5) receiving results with an explanation, and 6) being advised where to receive evaluation and management from qualified healthcare personnel. Methods: Our primary objectives were to create, register, and pilot a website as a public platform for cervical cancer prevention for both city and rural, individual and organizational application. We selected two sites: Shenzhen City in China as the local city (individual participant) site, and Sangzhi County in Hunan Province as the remote (group management) site. The website was reviewable to all of China, but applications for screening and registration were open only to the women from the 2 pilot sites. In the local site, the women would first sign up (obtain a password) to view the website (www.mcareu.com), and then if they desired, they could register for screening using their true name and their state ID. After an offline confirmation of the address, the sampling kit would arrive. Results were available with additional education and guidance for care also on the website. Findings: 120,099 people nationwide visited the website in 27 months by the end of May, 2015, 1148 women from the sites registered at the website and 87.5% enrolled in the pilot trial. 72.3% of those testing positive returned for management. Virtually 100% of the registration/historical information was entered appropriately and 100% of the samples were handled properly. Interpretation: Web-based decision aids help patients through the uncertainties of healthcare. Applied to cervical cancer screening using self-collection, the effectiveness of the model specifically in respect to accessibility, education, registration, data input, and instructions for positive management was clearly demonstrated by this pilot as well as the potential for future diagnostics applicable to self-collection.
基金the Science and Technology Research Project Foundation of Shanxi Province,China(201803D421049).
文摘Background:Dry specimen transport has shown equivalence to traditional liquid transport using a novel high-risk Human papillomavirus assay.Considering that dry transport might cross obstacles during cervical cancer screening in low and middle resource settings,this study was designed evaluate different processing time of dry specimen transport using the same isothermal amplification hrHPV assay.Methods:There were 564 women between the ages of 30–55 recruited from colposcopy clinic.For each patient,two endocervical samples were collected and placed into empty collection tubes by physician.Samples were stored at room temperature until analyzed for hrHPV using the AmpFire assay at two time points:2 days and 2 weeks.511 of the 564 participants with positive hrHPV were provided colposcopy exam and quadrant biopsy.Results:A total of 1128 endocervical samples from 564 patients were detected by the Ampfire assay.Good agreement was found between two time periods(KappaStandard error=0.67±0.04).Sensitivity(2days/2weeks)for CIN2t was 95.28%(95%CI:92.14%–98.42%)vs 90.57%(CI(86.65%–94.49%)and specificity(2days/2weeks)was 22.47%(CI 19.33%–25.61%)vs 28.15%(CI 24.23%–32.07%)respectively.The difference for Ampfire HPV detection in sensitivity for CIN2t for the two time periods was not significant(P=0.227),while the difference in specificity for CIN2t was significant(P=0.001).The difference in Ct values 29.23(CI 28.15–30.31)and 29.27(CI 28.19–30.35)between two time points was not significant(P?0.164).Conclusion:Processing dry brush specimens can be delayed up to 2 weeks.Using the AmpFire assay platform which supports cervical cancer prevention programs in low-to-middle-income countries(LMICs).
