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Cervical cancer screening

Self-collected vaginal samples

Clinical question

GUIDELINE UPDATES - This guideline was last updated 2/1/2021

UPCOMING GUIDELINES - This guideline was updated and comes into practice on 7/1/2022Download PDF

Background

Only six in 10 women participate in the National Cervical Screening Program (NCSP) 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 Register (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 human papillomavirus (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 NCSP, HPV testing on self-collected samples will be available to some women age 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 NCSP and are age 30 years or over
  • women who are overdue for cervical screening by 2 years or longer and are age 30 years or over.

See the National Cervical Screening Policy.

Evidence

MSAC systematic review

The MSAC 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 MSAC 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 MSAC 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 cervical intraepithelial neoplasia grade 2 or higher (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.

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 PCR 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) test result had the appropriate clinical follow-up within 6 months. Among 45 women with a positive oncogenic HPV (16/18) test result, 28 (62.2%) attended for colposcopy within 6 months, and attendance for colposcopy was lower among women with negative or LSIL cytology (18/27 attended) than among women with HSIL 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) 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 16/18.[10]

2020 analysis

Given the limited data on the outcomes for women with self-collected samples in the National Cancer Screening Register dataset available from the first 2 years of the renewed NCSP, referral to colposcopy continues to be recommended for all women at intermediate risk who test positive for HPV (any type) at 12 months after an initial positive test. This management decision is based on the higher underlying risk in under-screened women who are eligible for the self-collection pathway. By comparison, women with clinician-collected samples at intermediate risk (those with a positive oncogenic HPV (not 16/18) test result, for whom repeat HPV testing at 12 months is positive for oncogenic HPV (not 16/18) but reflex LBC does not predict pHSIL, HSIL, cancer or a glandular abnormality) can delay colposcopy and instead undergo a second repeated HPV test 12 months later (i.e. 24 months after the initial screen).

Recommendations

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

MSAC evidence-based recommendation
REC6.13: Oncogenic HPV types 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.
Note: recommendation numbering changed Feb 2021, this was previously 6.10
MSAC evidence-based recommendation
REC6.14: Referral of women with positive oncogenic HPV (16/18) test result (self-collected sample)
Women who have undergone HPV testing on a self-collected sample and have a positive oncogenic HPV (16/18) test result should be referred directly for colposcopic assessment. A cervical sample for LBC should be obtained at the time of colposcopy and is not required prior to referral.
Note: recommendation numbering changed Feb 2021, this was previously 6.11
Consensus-based recommendation

REC6.15: Women with a positive oncogenic HPV (not 16/18) 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) test result should be advised to visit their GP or healthcare professional to obtain a cervical sample for LBC:

  • If the LBC test result is negative or pLSIL/LSIL, HPV testing should be repeated in 12 months, preferably by a healthcare professional.
  • If the LBC test result is pHSIL/HSIL or any glandular abnormality the woman should be referred for colposcopy at the earliest opportunity, ideally within 8 weeks.


Approval: 1-Feb-2021
Note: recommendation numbering changed Feb 2021, this was previously 6.12

Consensus-based recommendation

REC6.16: Management of 12 month repeat HPV test result after initial positive oncogenic HPV (not 16/18) 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) test result should be referred for colposcopic assessment:
  • If the repeat HPV test was clinician-collected, reflex LBC will be available to inform colposcopic assessment.
  • If the repeat HPV test was self-collected, a cervical sample for LBC should be obtained at the time of colposcopy.


Approval: 1-Feb-2021
Note: recommendation numbering changed Feb 2021, this was previously 6.13

Practice point

REC6.17: 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 LBC can be performed on the same sample, which avoids a further visit to collect a cervical sample for LBC.

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.
Approval: 1-Feb-2021
Note: recommendation numbering changed Feb 2021, this was previously 6.14

Practice point

REC6.18: 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 (age >30 years, at least 2 years overdue for cervical screening test, or never been screened) as per NCSP policy.
Approval: 1-Feb-2021
Note: recommendation numbering changed Feb 2021, this was previously 6.15

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 regarding reassurance and explanation of the screening pathway and the procedure. Women who have a positive oncogenic HPV (any type) test result will require a clinician-collected cervical sample for LBC 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 Section 5. Benefits, harms and cost-effectiveness of cervical screening in the renewed NCSP.

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 NCSP 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 LBC 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) test result until after they have collected a cervical sample for LBC. However, women who have a positive HPV (16/18) test result should be referred directly to colposcopy and the cervical sample for LBC 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.

Author(s):

References

  1. Australian Institute of Health and Welfare. Cervical screening in Australia 2012–2013. Cancer series no. 93. Cat. no. CAN 91. Canberra: AIHW; 2015 Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129550872.
  2. Victorian Cervical Cytology Registry. Statistical Report 2013. Carlton South: The Victorian Cervical Cytology Registry(VCCR); 2013 Available from: http://www.vccr.org/site/VCCR/filesystem/documents/dataandresearch/StatisticalReports/VCS_StatisticsReport_2013_Web_SinglePages_Final.pdf.
  3. 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 Available from: 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: NHMRC; 2005.
  5. 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 Available from: 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 Available from: 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 Available from: http://www.ncbi.nlm.nih.gov/pubmed/20223872.
  9. 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 Available from: http://www.ncbi.nlm.nih.gov/pubmed/25713024.
  10. 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 Available from: 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 Available from: 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 Available from: http://www.ncbi.nlm.nih.gov/pubmed/26536865.
  13. 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 Available from: 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 Available from: http://www.ncbi.nlm.nih.gov/pubmed/24646201.

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