New technologies for cervical screening

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Policy Statement

The National Cervical Screening Program recommends Pap smears be used as the primary method for screening until there is sufficient evidence indicating the effectiveness of new cervical screening technologies.

Key Points

• The National Cervical Screening Program (NCSP) recommends that all women aged 18-69 years, who have ever been sexually active ¹, should have cervical screening by Pap smears every two years.
• The NCSP is a cost-shared program of the Australian and state and territory governments.
• The Pap smear is a screening tool used to detect early changes in the cervix which may give rise to cancer.
• The number of deaths from cervical cancer has been falling since the introduction of the NCSP which utilises the Pap smear as a screening tool.
• There are a number of new cervical screening technologies which may impact on the NCSP including liquid based cytology and Human Papillomavirus (HPV) DNA testing.
• The role of new technologies within the NCSP will be assessed as new evidence becomes available.

Rationale

The current method of cervical cancer control in Australia is the National Cervical Screening Program (NCSP). Since the establishment of the NCSP in 1991, deaths from cervical cancer in the target age group have fallen from 4.0 per 100,000 women (1991) to 1.8 per 100,000 women (2004). ²

The Pap smear has been an extremely successful screening tool in detecting cervical abnormalities and reducing incidence and mortality associated with cervical cancer. Before any new technology is recommended for use in the NCSP there must be sufficient evidence that it is as safe, effective and cost-effective as the Pap smear. Any change to current National policy would require the approval of the states and territories programs.

Currently there are a number of new cervical screening technologies, including:

Liquid based cytology with or without computer assisted image analysis

Liquid based cytology (LBC) is a method of preparing cervical samples for examination in the laboratory. LBC cervical samples can be collected in two ways, samples are either rinsed in preservative fluid from Pap smear collection tools following the preparation of a Pap smear (split sample) or samples are prepared directly from collection tools (direct-to-vial sample). Following processing, these samples are produced as a clean, single layer of cells which can be read either manually or in combination with computer assisted image analysis. The Medical Services Advisory Committee (MSAC) reviewed the technology in 2002 and found there was insufficient evidence on the performance of liquid based cytology to enable effective comparisons to Pap smears. ²

Computer assisted image analysis allows trained personnel to examine cervical smears in the laboratory. MSAC reviewed the technology in 2003 and recommended that manual cytology screening be maintained as there was insufficient evidence to support the implementation of computer assisted image analysis. ³

A new application for a combined liquid based cytology and computer assisted imaging system is currently being assessed by MSAC.

Addendum added 14 May 2011

The latest review mentioned above was completed in 2009, MSAC assessed LBC both automated (using a ThinPrep Imager) and LBC with manual reading. MSAC found that in comparison to conventional Pap smears, both technologies are safe and at least as effective but not cost effective at the price requested. MSAC recommended that LBC (manual and automated) should not be supported for public funding.⁴

HPV DNA testing

The majority of cervical cancers are associated with persistent infection with oncogenic human papillomavirus (HPV). An HPV DNA test can detect the presence of HPV infection in cervical cells. In June 2004, the Minister for Health and Ageing endorsed a recommendation from MSAC that high risk HPV testing be listed on the Medicare Benefits Schedule for monitoring, as a ‘test of cure’, for women following treatment for high-grade intra epithelial disease of the cervix. ⁵ This recommendation was based on evidence that HPV DNA testing can be used to reliably identify women at greatest risk of recurrent disease. In line with this MSAC recommendation and the NHMRC Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen-detected abnormalities ⁶, women with treated high-grade cervical abnormalities will require cytology and colposcopy 4-6 months after treatment; cytology and high risk HPV test at 12 months and then again at 24 months after treatment.

MSAC reviewed HPV testing for cervical screening either alone or as an adjunct to cytology in 2003 and found there was insufficient evidence to support the use of the technology as a screening tool. ³ HPV testing for triaging of women with equivocal screening results was also not recommended following a review by MSAC in 2002, which found insufficient evidence to support the technology for this purpose. ⁷

New evidence to support the use of HPV DNA testing for cervical screening has become available since 2002. As a result MSAC is currently assessing a new application for HPV DNA testing.

Addendum added 14 May 2011

The latest review mentioned above was completed in 2009. MSAC assessed HPV triage testing for women with possible or definite low-grade squamous intraepithelial lesions. MSAC found that compared with repeat recall cytology at one year, HPV triage testing is safe and effective but not cost effective in the Australian setting at the current price.⁸

Self Sampling

A number of new technologies are being promoted for women to self-collect samples for HPV DNA testing and cytology. These new technologies are currently not supported within the NCSP as there is insufficient evidence to support their use and they have not been assessed by the Medical Services Advisory Committee for use within the NCSP.

Optoelectronic cervical screening

Optoelectronic cervical screening is a method of detecting abnormalities of the cervix using an optoelectronic sensor to highlight abnormal areas of the cervix. In Australia, the optoelectronic device TruScreen is on the Australian Register of Therapeutic Goods (ARTG) however it is not recommended for use in cervical screening due to its low specificity (a high level of false positive results) which may result in increased anxiety for women and unnecessary investigations such as colposcopy.

The NCSP will continue to monitor the development of new technologies for cervical screening to maintain a high quality cervical screening program in Australia.

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• The national policy on HPV DNA testing
• Additional information on HPV
• More information on HPV DNA testing and self sampling

¹ The National Cervical Screening Program recommends women who have ever been sexually active should commence having Pap smears between the ages of 18 and 20, one or two years after first sexual intercourse, whichever is later. Commonwealth of Australia (1998). Screening for the prevention of cervical cancer.

² Australian Institute of Health and Welfare (2006). Cervical Screening in Australia 2003-2004.

³ Medical Services Advisory Committee (2003). Computer-assisted image analysis for cervical screening.

⁴ Medical Services Advisory Committee (2009). Automation-Assisted and Liquid-Based Cytology (LBC) for Cervical Cancer Screening.

⁵ Medical Services Advisory Committee (2004). The use of human papillomavirus testing to monitor effectiveness of treatment of high-grade intraepithelial abnormalities of the cervix.

⁶ National Health and Medical Research Council (2005). Screening to prevent cervical cancer: guidelines for the management of asymptomatic women with screen detected abnormalities.

⁷ Medical Services Advisory Committee (2002). Human papillomavirus testing in women with cytological prediction of low-grade abnormality.

⁸ Medical Services Advisory Committee (2009). Human Papillomavirus Triage Test for Women with Possible or Definite Low-Grade squamous intraepithelial lesions.

Page currency, Latest update: 17 May, 2011

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