Our analysis comparing the costs of using DNA methylation testing for triage instead of liquid-based cytology (LBC) within the Netherlands cervical screening programme has now been published as an open access peer reviewed publication in the journal Diagnostics.
Self-sample collection for human papillomavirus (HPV)-primary cervical screening has been adopted in some settings to complement traditional clinician-based sampling. It has the potential to increase coverage in under-screened groups because it removes some barriers posed by clinician-based sampling, such as the inconvenience of booking an appointment. However, a major limitation to self-collection is that, if the original self-collected sample is high-risk HPV positive, a second sample is needed for LBC triage (which looks for cytological abnormalities) to assess the need for colposcopy. LBC is resource intensive, has variable test performance, and requires people to attend a healthcare setting to have a clinician-collected sample taken. This additional step in the self-sampling pathway can lead to loss to follow-up (people not completing screening). DNA methylation assays such as the QIAsure® FAM19A4/mir124-2 DNA Methylation Test (QIAGEN, N.V, Hilden, Germany), can be used on self-collected samples, and could be used instead of LBC for triage in national screening programmes.
Using a decision tree model, we compared the costs of using LBC with using DNA methylation testing for triage within the Netherlands cervical screening programme, where self-sampling is available as an alternative to clinician-based sampling. It was informed with data from the Dutch cervical cancer screening programme, published studies, and manufacturer data, and used two alternative scenarios for the relative performance of DNA methylation and LBC, to account for uncertainties.
The study found that for the screening cohort (n = 807,269) where 22.1% self-sampled, the number of unnecessary colposcopies and CIN3+ diagnoses varied according to the relative performance of DNA methylation testing and LBC. Irrespective of relative performance, the cost per complete screen was lower and fewer people were lost to follow-up when using DNA methylation testing. The results indicate that, within an HPV primary screening programme that incorporates self-sampling, using the QIAsure Methylation Test for triage would reduce the cost per screen compared to LBC.
The analysis, first presented at Eurogin Congress in Bilbao in February 2023, was recently published as a peer reviewed article in Diagnostics and is freely available to read and download from the journal website.
Citation
Puri Sudhir K, Kagenaar E, Meijer M et al. Comparing the costs and diagnostic outcomes of replacing cytology with the QIAsure DNA Methylation Test as a Triage within HPV primary cervical cancer screening in The Netherlands. Diagnostics. 2023 Dec 6; 13(24):3612. doi:10.3390/diagnostics13243612
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