Self-collected vaginal samples

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Background

Only six in 10 women participate in the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. at the recommended 2-year interval.[1] In very remote regions, the 2-yearly participation rate is estimated at 55%.[1] There is a clear trend of decreasing participation with decreasing socioeconomic status, with an estimated participation rate of 52% in areas of lowest socioeconomic status.[1]

Data from the Victorian Cervical Cytology RegisterA database of identifiable persons containing defined demographic and health information, established for a specific purpose. In the case of cervical screening or other cancer screening registers, the purpose includes inviting eligible persons for screening, sending reminders when they are overdue for screening, follow up of abnormalities, statistical reporting and research. (VCCR) show that more than 80% of women diagnosed with invasive cervical cancer have never been screened or have participated in the screening program but were more than 6 months overdue for a recommended cytology test at the time of their cancer diagnosis.[2] Self-collection of HPV test samples has been suggested as a strategy to overcome barriers to undergoing a screening test that some women experience. Providing HPV self-collection kits to never-screened and under-screened women has been shown to improve screening participation in international studies.[3]

Under the renewed NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears., HPV testing on self-collected samples will be available to some women aged 30–74 years under the supervision of a healthcare professional who also offers cervical screening. The following groups of women will be eligible:[4]

  • women who have never participated in the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. and are 30 years of age or over
  • women who are overdue for cervical screening by 2 years or longer and are 30 years of age or over.

See the National Cervical Screening Policy.

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Evidence

MSACThe Australian Medical Services Advisory Committee systematic review

The MSACThe Australian Medical Services Advisory Committee evaluation assessed the comparative safety and effectiveness of including self-collected samples for HPV testing for never-screened and under-screened women, to supplement the organised screening program using clinician-collected samples for HPV testing, compared with the existing collection protocol.[5]

The MSACThe Australian Medical Services Advisory Committee assessment of accuracy of self-collected samples was based on 10 level III-2 diagnostic accuracy studies conducted in a screening setting, which were included in a systematic review.[3] Evidence for adherence rates was obtained from a randomised controlled trial[6] and two cohort studies.[7][8]

The MSACThe Australian Medical Services Advisory Committee systematic review made the following conclusions:[5]

  • The accuracy of HPV testing using self-collected samples varies between different types of sampling devices and HPV tests.
  • HPV tests using self-collected samples have moderate-to-high sensitivity and comparably high specificity for detecting CIN2+, compared with clinic HPV testing in nine of 10 studies identified, with a relative sensitivity of 0.62–1.00 and relative specificity of 0.93–1.00.
  • High rates of adherence to screening follow-up have been reported among previously unscreened women with a positive HPV test result from a self-collected sample.

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Other evidence

A more recent meta-analysis[9] found that the sensitivity and specificity of HPV testing to detect CIN2+ in self-collected samples were similar to those for clinician-collected samples when using validated PCRPolymerase Chain Reaction tests. When using signal amplification-based HPV assays, self-collected samples showed lower sensitivity than clinician-collected samples.[9][10]

Two recent studies conducted in Victoria suggest that offering self-collection is likely to be acceptable to Australian women who have not been screened recently.[11][12] One of these, a randomised controlled trial, additionally found that offering self-collection was more effective than a reminder letter in encouraging women who were unscreened or overdue for screening to undergo a round of screening.[13] Overall, 75.7% of women with a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result had the appropriate clinical follow-up within 6 months. Among 45 women with a positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result, 28 (62.2%) attended for colposcopy within 6 months, and attendance for colposcopy was lower among women with negative or LSILLow-grade squamous intraepithelial lesionThe low-grade squamous intraepithelial lesion (LSIL) category is the morphological correlate of productive viral infection. It is to be used when the scientist/pathologist observes changes that would have been described as ‘HPV effect’ or ‘CIN 1’ in the previous Australian terminology and represents part of the previous ‘low-grade squamous epithelial abnormality’ category. cytology (18/27 attended) than among women with HSILHigh-grade squamous intraepithelial lesionIn the Australian context, HSIL is used to refer to a cytology predictive of a high grade precancerous lesion (AMBS 2004), or histologically confirmed high grade precancerous lesion (HSIL-CIN2 or HSIL-CIN3 as per LAST terminology). cytology (8/8 attended).[13] The authors suggested that medical practitioners may not have referred women for colposcopy when subsequent cytology was negative.[13] The trial protocol had recommended colposcopy referral for women with a positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result, and did not require or actively recommend that cytology be collected prior to referral (this was at the discretion of the healthcare professional),[14] however cytology was collected from 35 of the 37 women who attended for any follow-up.[13]

A recent modelled analysis found that undergoing even one round of screening could substantially reduce an unscreened woman’s risk of cervical cancer over her lifetime, by around 41% if this occurred at age 30 or 40.[10] The authors noted that benefits of self-collection would be maximised by using a sufficiently accurate HPV test that had capacity to perform partial genotyping for HPV 16/18Only HPV types 16 and or 18 detected using routine HPV screening tests in laboratory..[10]
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Recommendations

Flowchart 6.2. Cervical screening pathway for primary oncogenic HPV testing using self-collected samples

Cervical screening pathway for self collection.PNG


MSACThe Australian Medical Services Advisory Committee evidence-based recommendationQuestion mark transparent.png

REC6.10: Oncogenic HPV typesOncogenic HPV are HPV types considered capable of causing cancer. Types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68 are included in tests suitable for cervical screening. Some tests also detect type 66. not detected in self-collected sample
Women who have undergone HPV testing on a self-collected sample and in whom oncogenic HPV is not detected should be invited to re-screen with a HPV test in 5 years and should be advised to have a clinician-collected sample.

MSACThe Australian Medical Services Advisory Committee evidence-based recommendationQuestion mark transparent.png

REC6.11: Referral of women with positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result (self-collected sample)
Women who have undergone HPV testing on a self-collected sample and have a positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result should be referred directly for colposcopic assessment. A cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. should be obtained at the time of colposcopy and is not required prior to referral.

Consensus-based recommendationQuestion mark transparent.png

REC6.12: Women with a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result (self-collected sample)
Women who have undergone HPV testing on a self-collected sample and who have a positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result should be advised to visit their GP or healthcare professional to obtain a cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory.:

  • If the LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. test result is negative or pLSILPossible LSIL in the Australian Modified Bethesda System is broadly equivalent to ASCUS in US Bethesda system./LSILLow-grade squamous intraepithelial lesionThe low-grade squamous intraepithelial lesion (LSIL) category is the morphological correlate of productive viral infection. It is to be used when the scientist/pathologist observes changes that would have been described as ‘HPV effect’ or ‘CIN 1’ in the previous Australian terminology and represents part of the previous ‘low-grade squamous epithelial abnormality’ category., HPV testing should be repeated in 12 months, preferably by a healthcare professional.
  • If the LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. test result is pHSILPossible HSIL in the Australian Modified Bethesda System is broadly equivalent to ASC-H in US Bethesda system./HSILHigh-grade squamous intraepithelial lesionIn the Australian context, HSIL is used to refer to a cytology predictive of a high grade precancerous lesion (AMBS 2004), or histologically confirmed high grade precancerous lesion (HSIL-CIN2 or HSIL-CIN3 as per LAST terminology). or any glandular abnormality the woman should be referred for colposcopy at the earliest opportunity, ideally within 8 weeks.
Consensus-based recommendationQuestion mark transparent.png

REC6.13: Management of 12 month repeat HPV test result after initial positive oncogenic HPV (not 16/18)Women with a positive HPV test result of other oncogenic HPV types other than types 16 and 18 detected using routine HPV testing in a pathology laboratory. test result on a self-collected sample
At 12-month repeat HPV testing:

  • Women in whom oncogenic HPV is not detected should return to routine 5 yearly screening, and should be advised to have a clinician-collected sample at that time.
  • Women with a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result should be referred for colposcopic assessment:
  • If the repeat HPV test was clinician-collected, reflex LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. will be available to inform colposcopic assessment.
  • If the repeat HPV test was self-collected, a cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. should be obtained at the time of colposcopy.
Practice pointQuestion mark transparent.png

REC6.14: Clinician-collected sample for follow-up HPV test after initial self-collected sample
When follow-up HPV testing is required after an initial positive oncogenic HPV test result, the sample should be collected by a clinician, if possible.

Women should be advised that a clinician-collected sample is preferred because it is more effective and reflex LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. can be performed on the same sample, which avoids a further visit to collect a cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory..

If the woman declines the clinician-collected sample, she can have a self-collected sample and is eligible for reimbursement under the Medical Benefits Schedule.

Practice pointQuestion mark transparent.png

REC6.15: Clinician-collected sample after invitation to re-screen
Women who are invited to have a clinician-collected sample, and decline, will not be eligible for self-collection at that time.

Not eligible for reimbursement under the Medical Benefits Schedule unless they meet the eligibility criteria for self-collection (aged > 30 years, at least 2 years overdue for cervical screening test, or never been screened) as per NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. policy.

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Benefits and harms

Women who are eligible for the self-collection pathway will benefit by participation in screening, especially if disease is detected and treated. They will also benefit by being reassured that they are at low risk of cervical cancer if oncogenic HPV is not detected.

Women who are eligible for self-collection may be more anxious about cervical screening than other women and will need special consideration in regard to reassurance and explanation of the screening pathway and the procedure. Women who have a positive oncogenic HPV (any type)Women with a positive HPV test result of any oncogenic HPV types detected using routine HPV testing in a pathology laboratory. test result will require a clinician-collected cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. and should be guided through this process in a sensitive and culturally appropriate manner. Women who have a positive HPV (16/18) test result can have this sample collected at colposcopy. It is also important that health professionals communicate the meaning of HPV test results in a sensitive and culturally appropriate manner.

See Chapter 5. Benefits, harms and cost-effectiveness of cervical screening in the renewed NCSP.

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Health system implications of these recommendations

Clinical practice

Women who are eligible for self-collection must be given clear information by the supervising healthcare professional about the self-collection technique, how they will receive the test results and what follow-up will be required if the HPV test result is positive.

Resourcing

If women who have been regular participants in the NCSPNational Cervical Screening ProgramA joint program of the Australian, state and territory governments. It aims to reduce morbidity and mortality from cervical cancer, in a cost-effective manner through an organised approach to cervical screening. The program encourages women in the target population to have regular Pap smears. delay their screening attendance to become eligible for self-collection, they may require two visits to their healthcare provider, which will increase the costs of the program.

Barriers to implementation

Women may fail to respond to an invitation for self-collection. If the woman sees a healthcare professional for a different reason and the medical record reveals that the woman is eligible for self-collection (never screened or under-screened) it would be appropriate for the healthcare professional to encourage cervical screening.

Women with a positive oncogenic HPV test result may fail to undergo follow-up for further assessment, which should include taking a cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. and/or colposcopy.

It is possible that some healthcare professionals may choose to delay colposcopy referral for women with a positive oncogenic HPV (16/18)Women with a positive HPV test result of HPV types 16 and/or 18 detected using routine HPV testing in a pathology laboratory. test result until after they have collected a cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory.. However women who have a positive HPV (16/18) test result should be referred directly to colposcopy and the cervical sample for LBCLiquid based cytology(LBC) is a way of preparing cervical samples for examination in the laboratory. will collected by the colposcopist.

Key messages to educate women and healthcare professionals about the self-collection option and subsequent management of any abnormalities will be developed as part of implementation planning to support this guideline.

See the National Cervical Screening Program Policy.

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References

  1. 1.01.11.2 Australian Institute of Health and Welfare. Cervical screening in Australia 2012–2013. Cancer series no. 93. Cat. no. CAN 91. Canberra: AIHWAustralian Institute of Health and Welfare; 2015 Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129550872.
  2. Victorian Cervical Cytology RegistryA database of identifiable persons containing defined demographic and health information, established for a specific purpose. In the case of cervical screening or other cancer screening registers, the purpose includes inviting eligible persons for screening, sending reminders when they are overdue for screening, follow up of abnormalities, statistical reporting and research.. Statistical Report 2013. Carlton South: The Victorian Cervical Cytology RegistryA database of identifiable persons containing defined demographic and health information, established for a specific purpose. In the case of cervical screening or other cancer screening registers, the purpose includes inviting eligible persons for screening, sending reminders when they are overdue for screening, follow up of abnormalities, statistical reporting and research.(VCCR); 2013 Available from: http://www.vccr.org/site/VCCR/filesystem/documents/dataandresearch/StatisticalReports/VCS_StatisticsReport_2013_Web_SinglePages_Final.pdf.
  3. 3.03.1 Snijders PJ, Verhoef VM, Arbyn M, Ogilvie G, Minozzi S, Banzi R, et al. High-risk HPV testing on self-sampled versus clinician-collected specimens: a review on the clinical accuracy and impact on population attendance in cervical cancer screening. Int J Cancer 2013 May 15;132(10):2223-36 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22907569.
  4. National Health and Medical Research Council. Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities. Canberra: NHMRCNational Health and Medical Research Council; 2005.
  5. 5.05.1 Medical Services Advisory Committee. National Cervical Screening Program renewal: executive summary. Report November 2013.MSAC application no. 1276. Assessment report. Canberra: Australian Government Department of Health; 2014 Available from: http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/E6A211A6FFC29E2CCA257CED007FB678/$File/Executive%20Summary%20notated%2013.6.14.pdf.
  6. Tamalet C, Le Retraite L, Leandri FX, Heid P, Sancho Garnier H, Piana L. Vaginal self-sampling is an adequate means of screening HR-HPV types in women not participating in regular cervical cancer screening. Clin Microbiol Infect 2013 Jan;19(1):E44-50 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23137168.
  7. Szarewski A, Cadman L, Mallett S, Austin J, Londesborough P, Waller J, et al. Human papillomavirus testing by self-sampling: assessment of accuracy in an unsupervised clinical setting. J Med Screen 2007;14(1):34-42 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/17362570.
  8. Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, et al. HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ 2010 Mar 11;340:c1040 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20223872.
  9. 9.09.1 Arbyn M, Castle PE. Offering Self-Sampling Kits for HPV Testing to Reach Women Who Do Not Attend in the Regular Cervical Cancer Screening Program. Cancer Epidemiol Biomarkers Prev 2015 May;24(5):769-72 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25713024.
  10. 10.010.110.2 Smith M, Lew JB, Simms K, Canfell K. Impact of HPV sample self-collection for underscreened women in the renewed Cervical Screening Program. Med J Aust 2016 Mar 21;204(5):194 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26985849.
  11. Mullins R, Scalzo K, Sultana F. Self-sampling for cervical screening: could it overcome some of the barriers to the Pap test? J Med Screen 2014 Dec;21(4):201-6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/25312640.
  12. Sultana F, Mullins R, English DR, Simpson JA, Drennan KT, Heley S, et al. Women's experience with home-based self-sampling for human papillomavirus testing. BMC Cancer 2015 Nov 4;15:849 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26536865.
  13. 13.013.113.213.3 Sultana F, English DR, Simpson JA, Drennan KT, Mullins R, Brotherton JM, et al. Home-based HPV self-sampling improves participation by never- and under-screened women: Results from a large randomised trial (iPap) in Australia. Int J Cancer 2016 Feb 6 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/26850941.
  14. Sultana F, English DR, Simpson JA, Brotherton JM, Drennan K, Mullins R, et al. Rationale and design of the iPap trial: a randomized controlled trial of home-based HPV self-sampling for improving participation in cervical screening by never- and under-screened women in Australia. BMC Cancer 2014 Mar 19;14:207 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/24646201.
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