IBMS Response: At-Home PSA Tests

The Institute of Biomedical Science (IBMS), the professional body for regulated scientists working in healthcare, acknowledges the BBC's findings regarding the inconsistent and inaccurate results produced by at-home prostate-specific antigen (PSA) tests. While we support innovations that increase public access to diagnostic tools, we emphasise that consumer tests must meet rigorous standards to ensure accuracy, reliability, and clinical relevance.

Key Concerns with At-Home PSA Tests

1. Lack of Accuracy and Reliability
• The BBC's investigation highlights the variability of results among at-home PSA test kits, with one test failing entirely and another producing a false positive. This raises concerns about the quality control, sensitivity, and specificity of these tests.
• PSA levels can fluctuate due to various benign factors, such as infections, recent physical activity, or ejaculation. A single at-home test result, without proper clinical context, can lead to undue anxiety or false reassurance.
2. Regulatory Gaps and Inconsistent Standards
• The Medicines and Healthcare products Regulatory Agency (MHRA) states that over-the-counter PSA kits are "not a reliable indicator of prostate cancer" and should not claim to detect cancer. However, current regulations permit marketing language that suggests these tests can "assess prostate cancer risk."
• Some at-home test kits are sold with packaging labelled "for professional use only," indicating a misalignment between their intended use and consumer accessibility.
3. Clinical Pathway Considerations
• NHS laboratory PSA testing is not performed in isolation; it is part of a broader clinical assessment that considers risk factors such as age, ethnicity, and family history.
• NHS laboratory PSA tests are clinically validated by biomedical scientists to ensure that they perform correctly, are high quality and support the diagnostic question being asked.
• Laboratory-based PSA testing follows stringent quality assurance protocols, ensuring consistent, precise results that are interpreted by trained, regulated healthcare professionals.
• The interpretation of PSA levels requires professional medical judgment. In contrast, rapid at-home tests provide a binary result (positive or negative), which does not reflect the nuanced nature of PSA interpretation in clinical settings.

The Need for a Responsible Approach

While direct-to-consumer testing has potential benefits, such as increasing awareness and prompting earlier consultations with healthcare providers, its implementation must not compromise patient safety or clinical effectiveness. Lessons from other areas of diagnostic testing, including sexual health, highlight the risks of unregulated private testing, which can lead to unnecessary anxiety, misinterpretation of results, and increased pressure on NHS services for confirmatory testing.

IBMS Recommendations

1. Stronger Regulation and Quality Standards
• The MHRA and other regulatory bodies should strengthen oversight of at-home PSA test manufacturers to ensure accuracy, clinical validity, and reliability before these products reach consumers.
• Clearer restrictions on marketing language should be implemented to prevent misleading claims about cancer detection and risk assessment.
2. Public Education and Clinical Guidance
• Greater public awareness is needed to differentiate at-home PSA tests from NHS laboratory testing. Men concerned about prostate cancer should be encouraged to consult their GP rather than rely on self-testing.
• Healthcare professionals should be prepared to manage the consequences of inaccurate at-home test results, including unnecessary referrals or false reassurance.
3. Integrated Testing Pathways
• Where private sector testing is available, pathways should be established to integrate results into NHS care, ensuring proper follow-up and reducing the burden of unnecessary repeat testing.
• A collaborative approach between public health bodies, private test providers, and regulators is essential to establish best practices and protect patient safety.

Conclusion

At-home PSA tests, in their current form, present significant concerns regarding accuracy, regulation, and patient safety. While increasing access to diagnostic testing is valuable, this must not come at the cost of clinical integrity or public trust. The IBMS calls for greater regulatory scrutiny, enhanced public education, and integrated healthcare pathways to ensure that testing strategies support early diagnosis without compromising patient care.

We urge men concerned about their prostate health to seek professional medical advice and utilise NHS laboratory-based testing, which provides the accuracy, context, and expert interpretation necessary for informed clinical decision-making.