Warnings of Inaccurate Home Test Kits for Prostate Cancer.

New at-home rapid tests for prostate-specific antigen (PSA), which resemble COVID-19 lateral flow tests, have been found to produce inconsistent and inaccurate results, according to a BBC News investigation (https://www.bbc.co.uk/news/articles/cgl00gn15y8o).

In tests conducted by the BBC, five different rapid PSA tests were analysed - one test failed to work; three returned negative results; and one produced a false positive, all from the same single blood sample.

The charity Prostate Cancer UK has expressed significant concerns about these tests due to their questionable accuracy and the lack of professional medical interpretation. In the UK, there is currently no national screening program for prostate cancer - instead, men over 50, or over 45 for higher-risk groups, are advised to request a PSA blood test from their GP. The Medicines and Healthcare products Regulatory Agency (MHRA) has stated that over-the-counter PSA kits are "not a reliable indicator of prostate cancer" and should not claim to detect cancer.

The use of unreliable at-home PSA tests poses significant risks for patients. False negative results may lead individuals to mistakenly believe they are free of prostate cancer, delaying necessary medical evaluation and treatment. Conversely, false positives can cause unnecessary anxiety and lead to invasive follow-up procedures such as biopsies, which carry risks of infection and other complications. Without proper medical interpretation, these tests could contribute to misdiagnosis and inappropriate decision-making, potentially affecting patient outcomes and increasing the strain on healthcare services.

I would like to warn that the use of inaccurate at-home PSA tests could lead to serious legal and medical consequences. Patients who rely on these tests without consulting a doctor may face delayed diagnoses, reducing their chances of effective treatment and potentially leading to worse outcomes. If a patient suffers harm due to misleading results, they may have grounds for a negligence claim against manufacturers or sellers who fail to provide accurate information about the limitations of these tests.

Additionally, GPs and healthcare providers could face legal challenges if they do not properly advise patients on the unreliability of such tests, emphasising the importance of seeking professional medical advice rather than relying on unregulated home testing kits.

If you require advice on this, or any other medical negligence issue please contact me or any member of our expert Clinical Negligence Team.