HPV primary screening

Some more information and some non-binding advice regarding the planned switch to primary HPV screening from 1 January 2025.
 
The publication of the new nomenclature in the Official Gazette - which entails the switch from cytological to molecular screening - is expected in November so that it can take effect on the first day of the second month following the month of publication, i.e. 1 January 2025.


In the meantime,  the integrated communication on the introduction of the HPV test (released by Sciensano on Wednesday 23 October) with guidelines are made available in attachment. 

Work continues on drafting  the BELAC guidelines that will be communicated by Sciensano and made available on their portals soon. These will not contain earth-shattering, new information not previously shared with you.
 
Please find also attached the presentation on primary HPV screening given by colleague Kristof Cokelaere on the occasion of the Belgian Week of Pathology. Interesting and a powerful summary of this whole burlesque.
 
Attached you will also find an example of a draft request form for cervicovaginal cytology in times of primary HPV screening. For us too, this is still a draft and subject to changes based on input we receive from pathologists, gynaecologists, Sciensano and the Cancer Registry. You may still receive updates on this from us. It's free to use, not mandatory and it may get you started in the meantime.
 
At BELAC and at the RIZIV/INAMI, a complaint was made by the Commission on anatomic pathology (CPA/CAP) regarding the waiting times experienced by some laboratories for an initial audit preventing them from performing HPV tests under accreditation on 1 January 2025 because no audit can take place in time. We asked the BELAC and RIZIV/INAMI for a solution to the question ‘What about laboratories that wish to be able to perform HPV tests from 1 January 2025 but are not yet accredited for this? Will they be allowed to perform these tests and invoice them (later)?’ We will keep you posted on the responses.
 
I would also like to give you the following non-binding advice:

  • Take control of the pre-analytical phase: make application forms and collection material available to your customers. Whoever controls the pre-analytical phase controls the rest.
  • Do not change the current flow of samples from customers to the laboratory and be in charge of triaging the samples yourself. Don't leave the triage to our customers! Don't let them decide which lab the samples should be sent to.
  • Do the triage ‘cytological versus molecular testing’ based on the information provided on the request form. A request form that allows quick visual triage is therefore crucial!
  • Register in the LIS only those samples that you will primarily examine yourself.  If you do not perform HPV-testing, there is no interest of registering these samples in your LIS. In other words, triage comes before registration in the LIS!
  • Links between LIS systems of different labs to record ‘results’ of HPV tests and cytology tests are redundant and disproportionately costly versus the added value. Do not be compelled to set up such links.
  • If both cytology and molecular tests are to be performed on the same sample, perform the cytology test first. Cytology first, then HPV.
  • Integrated advice should only be provided when reflex-testing is done in screening context, not when cotesting is demanded or in follow-up.
  • If your laboratory performs triage, record the time spent on this and the number of samples sent for molecular testing, and make sure costs are settled in time & material between your laboratory and the laboratory that performs HPV testing for you. If both laboratories are operated by the same institution, this ‘transfer pricing’ can easily be settled. The tarifs for primary tests include 1.5 EUR for the cost of the collection material (brush + container).  This cost was not taken into account in the prices of the reflex tests! The material cost to perform cytology is included in the rate of the cytology test.
  • If, as a lab, you manage the pre-analytical phase as described above, in principle you also choose which laboratory you cooperate with for the HPV tests and you prevent a change of supplier (e.g. Hologic versus BD) over your head, without your participation, as a result of which investments made would suddenly become ‘worthless’.

 This advice was formulated in the board meeting of your professional union on Monday 14 October.
 
We hope to be of service to you with this and of course remain available for further information.
 
Best regards,
 
Romaric Croes en Koen Van De Vijver