Update for laboratories who test samples for the National Cervical Screening Program
Find out about 2 new requirements for laboratories who test samples for the National Cervical Screening Program.
Laboratories who test samples for the National Cervical Screening Program (NCSP) must follow 2 new sets of requirements.
The National Pathology Accreditation Advisory Council (NPAAC) has released:
- Cervical Requirements — Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (Second Edition 2019)
- Self-collection Requirements — Requirements for Validation of Self-Collected Vaginal Swabs for Use in the National Cervical Screening Program (2019)
Changes to the Cervical Requirements
The Cervical Requirements replace the first edition from 2017. They outline what labs who test samples under the NCSP need to do.
Changes in monitoring HPV rates
Labs must routinely monitor the proportion of screening tests that are HPV positive.
They then compare this with national rates from the National Cancer Screening Register (NCSR). If there is a large difference between these 2 rates, the lab must investigate why.
The Guidelines for handling HPV positivity rates explain how labs should investigate HPV positivity rates that are significantly different to the national rates.
The NCSR will continue to publish quarterly national average HPV positivity rates. These include the breakdown by date of birth (pre- and post-30 June 1980).
Notification of reagent failure
A reagent is a chemical used to test a batch of samples. If a lab suspects a problem with a reagent, they must investigate. If they find reagent failure that might affect other test providers, they must immediately notify:
- the Therapeutic Goods Administration (TGA), using their incident reporting scheme
- the NCSP, by emailing the Reagent Batch Failure Notification form in the Guidelines to NCSROperations [at] health.gov.au
The Guidelines describe how to handle notifications.
No commercially supplied HPV tests are currently approved for screening using self-collected vaginal swabs.
NPAAC has developed Self-collection Requirements to outline what a lab must do to offer testing of self-collected vaginal swabs for HPV under the NCSP.
An ‘applicant’ lab seeking accreditation to test self-collected vaginal swabs must work with a ‘comparator’ lab. The applicant lab must show that its testing of self-collected vaginal swabs is accurate enough to offer the test to women.
- have had the accuracy of their testing for self-collected vaginal swabs compared against specimens collected by health care workers
- have been accredited to test for HPV on self-collected swabs
Two labs are currently accredited to test for HPV on self-collected vaginal swabs:
Applicant labs wishing to offer testing of self-collected samples must have their assays checked against a comparator lab.
Comparator labs contact details
- Douglass Hanly Moir Pathology
- Contact – Dr Ian Chambers
- Email – ichambers [at] dhm.com.au
- Phone – (02) 9855 5311
- VCS Pathology
- Contact – Associate Professor David Hawkes
- Email – dhawkes [at] vcs.org.au
- Phone – (03) 9250 0030
For advice on these NPAAC requirements, please NPAAC [at] health.gov.au (contact NPAAC).