Marion Saville (Australia)
VCS Foundation ExecutivePresenter of 6 Presentations
Self-sampling and other strategies for cervical cancer screening and management in low and middle income countries (ID 1649)
CLINICAL VALIDATION OF A HIGH VOLUME HUMAN PAPILLOMAVIRUS ASSAY WITH EXTENDED VACCINE RELEVANT GENOTYPING (ID 683)
Abstract
Introduction
With a growing number of countries moving to large regional, or national, HPV-based screening programs there is a growing need for high volume (>1000 tests per day) clinically validated HPV assays to support these programs. The introduction of the Gardasil vaccine has also driven interest in understanding the role of HPV31,33,45,52, and 58 in screening programs and pathways.
Methods
The Abbott alinity m HPV assay run on the alinity m instrument was compared to the reference Roche cobas 4800 HPV test using the Meijer Criteria framework to examine sensitivity and specificity for histologically confirmed cervical intraepithelial neoplasia grade two or above (CIN2+). Intra- and Inter-laboratory reproducibility was also examined. The alinity m HPV assay is currently not approved for clinical use but this is expected to change in late 2019. Samples for this study are from the Compass Trial which is a consent-based trial and this current study has ethics approval.
Results
Relative Sensitivity for histologically confirmed CIN2+ is 96.7% (95%CI 88.5-99.6%). Currently (n = 300 of 805 tested to date) relative specificity for CIN2+ is over 99%. Final results, including sensitivity, specificity and inter- and intra-laboratory reproducibility will be presented.
Conclusions
Current data suggests that the Abbott alinity m HPV assay has sensitivity and specificity that is comparable to Roche cobas 4800 HPV reference test with the additional utility of producing a more detailed HPV genotyping profile (HPV16, HPV18, HPV45, HPV31/33/52/58, HPV35/39/51/56/59/66/68) which may be useful in monitoring Gardasil9 vaccine impacts on screening programs.
SELF-COLLECTION OR PRACTITIONER-COLLECTED EVALUATION (SCOPE) STUDY: EXAMINING WHETHER USING A COPAN FLOQSWAB IS NON-INFERIOR TO PRACTIONER-COLLECTED SPECIMENS ACROSS SIX HPV ASSAYS (ID 687)
- Marion Saville (Australia)
- David Hawkes (Australia)
- Marco H. Keung (Australia)
- Ellen Ip (Australia)
- Julie Silvers (Australia)
- Farhana Sultana (Australia)
- Michael J. Malloy (Australia)
- Louiza S. Velentzis (Australia)
- Karen Canfell (Australia)
- C. David Wrede (Australia)
- Julia M. Brotherton (Australia)
Webcast
EVALUATING THE IMPLEMENTATION OF THE SELF-COLLECTION CERVICAL SCREENING PATHWAY FOR SCREENING IN VICTORIA: PROVIDER PERSPECTIVES (ID 792)
Abstract
Introduction
The renewal of the Australian National Cervical Screening Program (rNSCP) enabled HPV self-collection to be made available to women over 30 years who were at least 2 years overdue or never-screened women. The introduction of self-collection was one of the aspects of the rNCSP that practitioners felt less confident with. The aim of this study is to interview practitioners using self-collection to understand how the program is working and develop recommendations to improve uptake.
Methods
VCS Pathology held contact details for all practitioners who sent self-collect samples for testing between the period of December 1, 2017 and March 2019. Practitioners were recruited from VCS data based on their use of and experiences with self-collection. Interviews with practitioners (n=17) were audio-recorded and coded in N-Vivo.
Results
Practitioners were highly positive about the self-collection pathway because of its’ acceptability to women. Self-collection addressed barriers due to gender of the provider, logistic barriers (e.g rurality) and barriers due to the experience of women (eg. sexuality and gender identity, history of sexual violence and attitudes to clinical examination). Restrictions to women’s eligibility for self-collection was cited as a key barrier to expanded implementation. The implementation of self-collection varied significantly between practices with some practices taking a proactive approach to incorporating self-collection into regular practice. Practitioners’ motivation and engagement both significantly reduced barriers to implementation and increased uptake. This was particularly true of practices where the barriers to uptake were around the characteristics of the practice (eg. rurality and availability of female practitioners).
Conclusions
Overall participating providers found that self-collection was an effective and acceptable way to improve the uptake in never and under-screened women. The success of the program is increased by incorporating self-collection into regular practice management and tailoring the processes to the specific needs of the practice.
CLINICAL VALIDATION OF AN EXTENDED GENOTYPING HUMAN PAPILLOMAVIRUS ASSAY USING A VERSATILE, SMALL LABORATORY SYSTEM (ID 686)
Abstract
Introduction
Whilst most HPV-based screening programs focus on high volume HPV assays and accompanying instrumentation, there is also emerging interest in HPV assays which can be run on small, flexible platforms on which a wide range of other assays can be utilised. Such systems may have considerable usefulness in low and middle income settings.
Methods
The AusDiagnostics High-Risk HPV panel was compared to the reference Roche cobas 4800 HPV test using the Meijer Criteria framework to examine relative sensitivity and specificity for histologically confirmed cervical intraepithelial neoplasia grade two or above (CIN2+). Intra- and Inter-laboratory reproducibility was also examined. Samples for this study are from the Compass Trial which is a consent-based trial and this current study has ethics approval.
Results
Relative sensitivity for histologically confirmed CIN2+ was 100% (95%CI 94.8-100%). Relative specificity for CIN2+ is 98.9% (95%CI 97.8-99.5%). Intra-laboratory reproducibility had a lower confidence interval of >87% and inter-laboratory data will also be presented.
Conclusions
The AusDiagnostics High-Risk HPV panel is as sensitive and specific as the Roche cobas 4800 HPV reference test. The AusDiagnostics High-Risk HPV panel also presents individual genotyping for the twelve oncogenic HPV types and HPV66 and HPV68a/b.
EVALUATING THE IMPLEMENTATION OF THE SELF-COLLECTION CERVICAL SCREENING PATHWAY FOR SCREENING IN VICTORIA: PARTICIPANT PERSPECTIVES (ID 782)
Abstract
Introduction
There has been a plateau in the reduction of cervical cancer in Australia without significant change since 2002 due to a decline in screening participation. The renewal of the Australian National Cervical Screening Program (rNSCP) enabled HPV self-collection to be available to women over 30 years who were at least 2 years overdue or never-screened. The aim of this study is to evaluate the implementation of the self-collection cervical screening pathway in Victoria from the participant perspective.
Methods
VCS Pathology was the only laboratory in Australia accredited to conduct testing for self-collected screening samples at the time of the study. VCS held contact details for all screening participants involved in the self-collection pathway. Screening participants were recruited for semi-structured interviews through a two-stage opt-out process which involved both screening participants and their practitioners. Interviews with screening participants (n=23) were audio-recorded and coded in N-Vivo using template analysis.
Results
There were diverse reasons that participants were overdue or never screened. They included logistic barriers (e.g rurality), sexuality and gender identity, history of sexual violence and previous experience with clinical examination. There was a diversity in the implementation of self-collection due to differences in adoption practices between clinical settings. Despite this, all participants expressed a high degree of satisfaction with self-collection and identified that the availability of self-collection, as well as their practitioner’s engagement, as being critical to their decision to participate in screening. Empowerment was a key theme of the interviews.
Conclusions
Overall self-collection is an effective and acceptable way to improve the uptake of screening in never and under-screened women. The success of the program is due to providing flexibility without compromising clinical confidence. Ongoing availability and expanded self-collection will be critical to reaching under and never screened women to ensure equity in cervical cancer prevention in Australia.