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Off-the-shelf medical tests are failing to back up accuracy promises with evidence, study finds

UNITED KINGDOM, JUL 24 – Researchers found 60% of self-tests pose high risks due to poor accuracy evidence and inadequate user guidance, prompting calls for stronger regulation to protect consumers and the NHS.

  • A study published in the BMJ reported that researchers bought 30 self-testing kits in 2023, finding many lacked evidence supporting their accuracy and had high error rates.
  • Professor Jon Deeks noted that the proliferation of new self-test kits in recent years prompted the NIHR to fund a comprehensive evaluation, as no prior study had reviewed kits available on the UK high street.
  • Performance data showed 14 tests claimed 98% accuracy, yet 18 were judged high-risk due to errors and evidence was not publicly available.
  • The MHRA responded by calling for guidance, with Joseph Burt, MHRA head of Diagnostics, saying it would review the evidence and consider all allegations of device deficiencies, while Bernie Croal warned of the risks of false reassurance and the impact on the NHS.
  • Market forecasts suggest the UK self-test market could reach £660 million by 2030, with researchers highlighting the potential for improved patient care amid ongoing monitoring of market expansion since 2023.
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Medical Xpress broke the news in on Wednesday, July 23, 2025.
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