Marta del Pino
Physician at the Gynecological Oncology Unit at the Hospital Clínic of Barcelona, scientific coordinator at the Clinical Institute of Gynecology, Obstetrics and Neonatology (ICGON) and associate professor at the University of Barcelona
The study evaluates whether it is possible to detect the human papillomavirus (HPV) in menstrual fluid collected with a minipad and compares its performance with cervical sampling performed by healthcare professionals to detect precancerous lesions of the cervix (CIN2+).
Overall, this is an interesting study because it proposes a non-invasive alternative to conventional HPV screening (performed by a doctor or midwife) and could be especially useful for women who do not undergo screening due to barriers such as discomfort, fear, or difficulty accessing services. The study includes a large community sample (more than 3,000 women with regular cycles) and makes a direct comparison with professional sampling. In this context, HPV detection in menstrual samples collected with a mini-sanitary swab shows good sensitivity (similar to that of conventional cervical sampling) for identifying CIN2+, with a very high negative predictive value. This means that a negative result greatly reduces the likelihood of actual CIN2+ lesions and can provide significant clinical reassurance.
That said, this study should not be considered an immediate replacement for current screening. There are important limitations: it only includes women who menstruate and have regular cycles, and it uses a prototype device that is not commercially available. Furthermore, as is common in many screening studies, not all women with negative results underwent biopsy; this may introduce verification bias and overestimate the test's performance.
It should also be considered that, by collecting material from the entire genital tract, the test could detect HPV infections not present in the cervix, increasing the number of false positives. In fact, as with any HPV-based strategy, the positive predictive value (i.e., the probability that a positive result actually corresponds to a CIN2+ lesion) is limited in the general population, and a significant proportion of positive results will not have a lesion. Before considering its use in clinical practice, implementation studies in other settings, comparisons with other self-sampling methods already available, and cost-effectiveness and care pathway analyses would be necessary.
In this context, it is worth remembering that other non-invasive strategies with solid evidence already exist. Self-sampling for HPV, when analyzed with PCR-based tests, has shown very similar performance to that of samples taken by a healthcare professional and is already considered in international recommendations as an option to increase participation in screening. Urine, collected in a standardized manner, is also a promising sample, although with more variable results between studies and often with lower specificity. Therefore, the value of this research is to open up an additional alternative that could be useful in certain scenarios, but it still needs replication and implementation research.