Session Type: 1-hour Oral Session
Session Title: 1-hour Oral Session
Authors(s): M. Martinelli (1), C. Giubbi (1), R. Musumeci (1), F. Perdoni (1), C. Molteni (1), M.L. Di Meo (2), F.P. Sina (2), R. Fruscio (2, 1), F. Landoni (2, 1), S. Castriciano (3), C. Cocuzza (1)
Authors Affiliations(s): (1) Department of Medicine and Surgery, University of Milano-Bicocca, Italy, (2) ASST Monza, Italy, (3) Copan Italia Spa, Italy
Background:
The use of HPV testing on self-samples has been well documented to be a valid alternative for cervical cancer screening; less is known about its possible introduction in a test of cure setting to monitor possible residual/recurrent disease in women treated for high-grade cervical dysplasia.
The aim of this ongoing study is to evaluate the accuracy of HPV testing on vaginal and urine self-samples collected from women before and after cervical dysplasia treatment as compared to clinician-collected cervical samples (gold-standard).
Methods:Self-taken vaginal (FLOQSwab®, Copan), urine (Colli-Pee, Novosanis) and physician-collected cervical samples were obtained as part of a longitudinal clinical study from 244 women attending the Colposcopy Clinic, San Gerardo Hospital (Monza, Italy). Presently, 81 patients have returned for at least 1 follow-up after 6/12 months. A total of 50 (50/244, 20.5%) women underwent conization at the time of colposcopy and 29 (29/50, 58%) have had one post-treatment follow-up visit. All samples were extracted with Microlab Nimbus platform and HPV detection was carried out using AnyplexII HPV28 (Seegene).
Results:Preliminary results have shown high HPV positivity rates among treated women with percentages of 96% (48/50), 94% (47/50) and 90% (45/50) in cervical, vaginal and urine samples, respectively. HPV16 and HPV31 resulted the most frequent types detected in all three different samples. 32 (32/50, 64%) cases of CIN2+ were detected among women who underwent conization; high-risk HPV type (hrHPV) positivity for CIN2+ was 100% (32/32) for cervical, 96.9% (31/32) for vaginal and 93.8% (30/32) for urine samples.
After treatment, 8 women (8/29, 27.6%) were hrHPV-positive from the analysis of cervical samples. Positivity for hrHPV was demonstrated in 44.8% (13/29) and 41.4% (12/29) of vaginal and urine samples, respectively. Seven of these women (7/8, 87.5%) showed persistent infection with the same hrHPV genotype.
Conclusions:Preliminary data showed a very good performance of AnyplexII HPV28 test on self-taken samples collected using FLOQSwab® and Colli-Pee devices compared to the gold standard cervical sample for the detection of high-grade cervical dysplasia. Further analysis obtained on a larger number of patients are necessary to evaluate a possible use of self-sampling to predict residual/recurrent disease avoiding unnecessary post-treatment visits.
Session Type: 1-hour Oral Session
Session Title: 1-hour Oral Session
Authors(s): M. Martinelli (1), C. Giubbi (1), R. Musumeci (1), F. Perdoni (1), C. Molteni (1), M.L. Di Meo (2), F.P. Sina (2), R. Fruscio (2, 1), F. Landoni (2, 1), S. Castriciano (3), C. Cocuzza (1)
Authors Affiliations(s): (1) Department of Medicine and Surgery, University of Milano-Bicocca, Italy, (2) ASST Monza, Italy, (3) Copan Italia Spa, Italy
Background:
The use of HPV testing on self-samples has been well documented to be a valid alternative for cervical cancer screening; less is known about its possible introduction in a test of cure setting to monitor possible residual/recurrent disease in women treated for high-grade cervical dysplasia.
The aim of this ongoing study is to evaluate the accuracy of HPV testing on vaginal and urine self-samples collected from women before and after cervical dysplasia treatment as compared to clinician-collected cervical samples (gold-standard).
Methods:Self-taken vaginal (FLOQSwab®, Copan), urine (Colli-Pee, Novosanis) and physician-collected cervical samples were obtained as part of a longitudinal clinical study from 244 women attending the Colposcopy Clinic, San Gerardo Hospital (Monza, Italy). Presently, 81 patients have returned for at least 1 follow-up after 6/12 months. A total of 50 (50/244, 20.5%) women underwent conization at the time of colposcopy and 29 (29/50, 58%) have had one post-treatment follow-up visit. All samples were extracted with Microlab Nimbus platform and HPV detection was carried out using AnyplexII HPV28 (Seegene).
Results:Preliminary results have shown high HPV positivity rates among treated women with percentages of 96% (48/50), 94% (47/50) and 90% (45/50) in cervical, vaginal and urine samples, respectively. HPV16 and HPV31 resulted the most frequent types detected in all three different samples. 32 (32/50, 64%) cases of CIN2+ were detected among women who underwent conization; high-risk HPV type (hrHPV) positivity for CIN2+ was 100% (32/32) for cervical, 96.9% (31/32) for vaginal and 93.8% (30/32) for urine samples.
After treatment, 8 women (8/29, 27.6%) were hrHPV-positive from the analysis of cervical samples. Positivity for hrHPV was demonstrated in 44.8% (13/29) and 41.4% (12/29) of vaginal and urine samples, respectively. Seven of these women (7/8, 87.5%) showed persistent infection with the same hrHPV genotype.
Conclusions:Preliminary data showed a very good performance of AnyplexII HPV28 test on self-taken samples collected using FLOQSwab® and Colli-Pee devices compared to the gold standard cervical sample for the detection of high-grade cervical dysplasia. Further analysis obtained on a larger number of patients are necessary to evaluate a possible use of self-sampling to predict residual/recurrent disease avoiding unnecessary post-treatment visits.