WOLLONGONG: A leading health sociologist has raised alarms over the growing popularity of direct-to-consumer (DTC) health tests, warning that these easy-to-access kits may pose significant risks to public health. Dr. Patti Shih, from the University of Wollongong’s Australian Centre for Health Engagement, Evidence & Values (ACHEEV), has called for urgent regulatory reforms and improved public awareness to safeguard consumers.
The surge in diagnostic technology and digital health has led to an increase in self-testing kits, ranging from food sensitivity and testosterone tests to multicancer detection and menopause indicators. While these tests are marketed as empowering tools for personal health management, Dr. Shih’s research, recently published in The BMJ, highlights serious concerns about their accuracy, reliability, and safety.
"Consumers are often exposed to incomplete or misleading marketing that can lead to harmful, ill-informed decisions about their health," said Dr. Shih.
These kits, widely available in pharmacies, supermarkets, and online, often bypass traditional healthcare systems, eliminating the need for a doctor’s consultation. However, researchers warn that the absence of dedicated regulatory frameworks means these products can cause more harm than good.
Key concerns raised by experts
Dr. Shih’s paper, coauthored with international researchers from Australia, the US, Denmark, and the UK, outlines several risks associated with DTC tests:
Inaccuracy of Results: Tests for fertility or menopause can provide incorrect information, potentially misleading users about their health status.
False Positives/Negatives: Faulty results may lead to unnecessary medical consultations or delay critical treatments.
Poor Instructions and Packaging: Incomplete or ambiguous instructions often result in improper use or misinterpretation.
Overdiagnosis and Distress: Results that aren’t clinically relevant may spark anxiety and unnecessary medical interventions.
Financial and Health Burdens: Misleading results can drive consumers toward non-evidence-based treatments, causing economic strain and physical harm.
A call for regulatory action
Dr. Shih emphasized the need for commercial suppliers to prove the benefit of their products, define appropriate target populations, and avoid harmful misinterpretations. She also urged regulatory bodies to address broader harms, including financial exploitation, psychological distress, and health risks linked to overdiagnosis.
"Regulations must evolve to match the pace of innovation in DTC testing. Consumers deserve transparency, reliability, and safety when accessing these products," Dr. Shih stated.
Public advisory
Consumers are urged to consult healthcare professionals before relying on DTC test results. While self-tests may offer convenience, they cannot replace the expertise of medical practitioners in diagnosing and managing health conditions.