Self-collection key messages

Healthcare providers and pathology sector

Broad awareness of pathway changes and timeline

From 1 July 2022, the National Cervical Screening Program (NCSP) will expand screening test options, offering self-collection of a vaginal sample as a choice to all people participating in cervical screening.

• These changes mean that you/your practice/your members may start to see an increase in the volume of requests from patients to use self-collection as an option for their Cervical Screening Test.
  
  
• From 1 July 2022 anyone eligible for a Cervical Screening Test under the NCSP (women and people with a cervix aged 25-74) will have the choice to screen either through self-collection of a vaginal sample using a simple swab (unless a co-test is indicated), or clinician-collection of a sample from the cervix using a speculum.
  
  
• Both screening options must be accessed through a healthcare provider.
  
  
• Self-collection is an option any time a human papillomavirus (HPV) test is needed, including for follow-up HPV testing after an intermediate risk result¹.
  
  
• Self-collection must be ordered and overseen by a healthcare provider who can also ensure timely clinician-collection of a cervical sample for liquid-based cytology (LBC) if required as part of a follow-up assessment.
  
  
• If HPV is detected on a self-collected vaginal sample, depending on the type of HPV detected, a clinician-collected cervical sample for LBC or referral to a specialist will be required.
  
  
• A healthcare provider is not required to observe the sample collection unless that is the person’s preference.
  
  
• People who may have difficulty (or are not confident) collecting a vaginal sample themselves, may be assisted to do so by the healthcare provider, or the healthcare provider may collect the sample on their behalf using a self-collection swab without using a speculum.
  
  
• Self-collection should be offered in a clinic setting wherever possible. However self-collection can occur in other settings at the discretion of the supervising healthcare provider, with the aim of maximising participation in cervical screening.
  
  
• Healthcare providers must clearly identify samples as self-collected on pathology request forms.
  
  
• It is the responsibility of the supervising healthcare provider to facilitate patient access to, and return of, self-collection swabs, request tests from laboratories, and communicate results and any follow-up requirements to patients.
  
  
• Self-collection is not appropriate for participants who require a co-test, for example because they:

 - are symptomatic (e.g. experiencing unusual vaginal bleeding, pain or discharge),
- are undergoing Test of Cure surveillance,
- have had a total hysterectomy with a history of high-grade squamous intraepithelial lesions, and
- have been exposed to Diethylstilbesterol (DES) in utero.

• The National Cervical Screening Program: Guidelines for the management of screen-detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding (NCSP Clinical Guidelines) have been updated to support the expansion of self-collection and will come into effect on 1 July 2022.

- The updated NCSP Clinical Guidelines bring together the best available evidence to prevent, diagnose and manage cervical cancer.
- Prior to 1 July, healthcare providers can view the updated NCSP guidelines at the PDF version available on the Cancer Council Australia’s website.

Availability and processing of self-collection samples

To ensure readiness to offer self-collection to patients from 1 July 2022, healthcare providers are encouraged to engage early with their local pathology laboratory to confirm they support processing of self-collected samples and to order the required swabs and other consumables.

• There is a range of collection devices and methods available for use under the NCSP for self-collected vaginal samples.
  
  
• Self-collection devices and methods will vary by pathology laboratory and laboratories may have varying collection and handling instructions and requirements.
  
  

Healthcare providers are encouraged to talk to their usual pathology provider in the first instance to:

- confirm that they can process self-collected vaginal samples, or
- that they are able to send on self-collected vaginal samples to a laboratory that can process self-collected vaginal samples, and
- order the correct collection device and other consumables for offering self-collection, and
- confirm any collection, handling and transport requirements.

Self-collection devices currently available include:

• Copan 552C dry flocked swab, red topped – for processing by accredited laboratories only. These swabs are delivered dry to the laboratory for processing.
  
  

If your local pathology provider is unable to process these types of self-collected samples or is unable to refer samples to an accredited laboratory for processing, healthcare providers can contact an accredited laboratory directly to arrange for processing of the sample. Australian pathology laboratories accredited to process these types of self-collected vaginal samples are:

VCS Pathology (VIC)
Contact: David Hawkes
Email: dhawkes@vcs.org.au | Phone: 0400 722 202

Douglass Hanly Moir Pathology (NSW)
Contact: Shirley George
Email: sgeorge@dhm.com.au | Phone: (02) 9855 6203

Sullivan Nicolaides Pathology (QLD)
Contact: Doctors Services
Email: doctors_services@snp.com.au | Phone: 1300 SNPATH (1300 767 284)

• Copan 552C.80 dry flocked swab, red-topped (Roche validated) – these must be re-suspended into a collection vial (e.g. ThinPrep) at time of collection. The collection vial is delivered to the laboratory for processing. Note this collection type is only available for self-collection in a clinic setting. Talk to your local laboratory about collection and handling requirements for processing these types of self-collected vaginal samples.
  
  
• Copan 5E089C dry flocked swab, white topped (Becton Dickinson (BD) validated). These swabs are delivered dry to the laboratory for processing. Talk to your local laboratory about collection and handling requirements for processing these types of self-collected vaginal samples.

Important considerations

Clinical information on pathology request forms helps pathology laboratories in performing the right tests, matching the right clinical recommendations and selecting the right Medical Benefits Schedule item/s.

To ensure the accurate and timely processing of self-collected samples, healthcare providers must:

• follow any self-collection handling and processing requirements and instructions provided by their laboratory
  
  
• clearly indicate that the sample has been self-collected on the pathology request form, and on the sample if appropriate
  
  
• ask the patient if they identify as Aboriginal and/or Torres Strait Islander and record the patient’s identification status on the pathology request form
  
  
• also seek to determine the patient’s CALD status, by recording their country of birth and language spoken at home, where possible.

Self-collection of a vaginal sample – accuracy

Recent evidence demonstrates a Cervical Screening Test using a self-collected vaginal sample is as accurate as a clinician-collected sample taken from the cervix during a speculum examination. 

A self-collected sample is taken from the vagina (not the cervix) and is tested for the presence of HPV. For asymptomatic participants there is strong evidence that HPV tests on self-collected vaginal samples and clinician-collected cervical samples have equivalent sensitivity when using a Polymerase Chain Reaction (PCR)-based HPV test2 – the test used by the National Cervical Screening Program.

• A recent meta-analysis has demonstrated the accuracy of self-collection.²
  
  
• Screening using a self-collected vaginal sample has equivalent sensitivity when compared to a clinician-collected cervical sample.
  
  
• A summary of the evidence of self-collection sensitivity can be found in the updated Clinical Guidelines.
  
  
• A self-collected sample is from the vagina (not the cervix). It can only be tested for HPV and not for cytology (cervical cell abnormalities). If a sample is positive for HPV, depending on the type of HPV detected, the participant will either need a speculum examination for LBC to determine management or will need to be sent directly for colposcopy.
  
  
• According to data from the National Cancer Screening Register, the current rate of unsatisfactory HPV samples (from self-collected samples) is under 2.6%³. This is well within the acceptable range.
  
  
• Patients with symptoms that could indicate cervical abnormalities or cancer require diagnostic testing and should be managed in accordance with the Clinical Guidelines.

Importance of self-collection as an option for participants, particularly hard to reach groups

• Self-collection provides a level of control and choice for patients, removing a significant barrier to participation in screening.
  
  There are some groups that are less likely to screen, including Aboriginal and/or Torres Strait Islander peoples, culturally and linguistically diverse communities, people who identify as LGBTIQ+, people with disabilities, people who have experienced sexual violence, post-menopausal people and people who have had previous negative cervical screening experiences. Self-collection may be more acceptable to these groups.

• Self-collection may also improve general screening participation.
  
  
• A pilot demonstrated that 85.7% of never or under-screened people who declined a speculum examination, agreed to HPV self-collection when the test was offered to them in a sensitive and culturally appropriate manner and with appropriate follow-up advice⁴.
  
  
• More than 70% of people diagnosed with invasive cervical cancer are under-screened or have never screened⁵.

Role of healthcare providers in the self-collection pathway

• Healthcare providers continue to play a central and critical role in the NCSP in assessing patient risk and using clinical judgement to recommend testing and follow-up.
  
  
• Healthcare providers will still need to offer a consultation for cervical screening whether it be a self-collected vaginal sample or clinician-collected cervical sample. Where self-collection is chosen, healthcare providers can use the time saved to discuss sexual health, post self-collection follow up and other health matters.
  
  
• Healthcare providers are best placed to talk with their patients about cervical screening to determine the best option of testing for their patients.
  
  
• Healthcare providers will need to explain to their patients how to collect a self-collected sample from the vagina.
  
  
• Healthcare providers must provide patients with clear information about the (low) likelihood that HPV may be detected on their self-collected vaginal sample and, if so, what follow up will be required.
  
  
• Healthcare providers should consider engaging an interpreter if needed. It’s free and can be booked via the Translating and Interpreting Service’s Doctors Priority Line on 1300 131 450.
  
  
• The NCSP remains committed to supporting healthcare providers to develop and maintain their cervical screening competencies.
  
  
• Practices using Best Practice, MedicalDirector and Communicare can now integrate their practice systems with the National Cancer Screening Register to view their patient’s cervical screening record directly within a patient record. All other users can access their patient’s screening records via PRODA. Visit the NCSR for more information.

For pathology laboratories only

National Pathology Accreditation Advisory Council (NPAAC) requirements: self-collection testing and referral

Providers of Medical Pathology Services must clearly identify self-collected vaginal samples for HPV testing as part of the NCSP.

The NPAAC Requirements for Medical Pathology Services outline the standards for good medical pathology practice, ensuring that patient and referrer’s (including healthcare providers or laboratories) expectations are safely and satisfactorily met in a timely manner.

Laboratories are able to process self-collected vaginal samples under the NCSP where they:

• are accredited to process self-collected vaginal samples under the NPAAC Requirements for Validation of Self-collected Vaginal Swabs for Use in the NCSP,
  
  or
  
  
• are accredited through verifying the use of one of the available TGA approved commercial devices to process self-collected vaginal samples (i.e. Roche or BD).

Laboratories that receive self-collected vaginal samples for processing but are unable to process samples in-house should continue to refer those samples on to a laboratory that can process them, including NPAAC accredited laboratories or accredited laboratories verified to use one of the commercial tests, as appropriate.

It is important that laboratories contact the referral accredited laboratory before July 2022 to allow for interlab reporting mechanisms to be set up.

Laboratories are encouraged to contact their healthcare providers to:

• Explain what self-collection devices and other consumables are required for self-collection testing, either at their laboratory or for the referral laboratory.
  
  
• Provide an updated swab chart and any collection processing and handling instructions.

Healthcare providers may also refer self-collected vaginal samples directly to accredited labs for processing where appropriate. More information on processing of self-collection samples can be found at the NCSP website.