The British In Vitro Diagnostics Association (BIVDA) wishes to address articles published today by the BBC and other media outlets regarding the UK private diagnostic testing market.

In Vitro Diagnostics are a key part of any health system. Before being placed on the market, tests are checked by the Medicines and Healthcare products Regulatory Agency (MHRA) to ensure they are safe and legal. The laboratories which analyse these tests adhere to stringent quality assurance standards. Tests supplied by the NHS also go through a rigorous procurement process before being placed in the hands of medical professionals.

Tests are complex and the results can be affected by many factors, such as diet, exercise, or natural fluctuations in hormone levels. This is well understood by the manufacturer or supplier and is covered in the instructions for use – which are part of the checks conducted by the MHRA. Tests which do not have suitable accuracy or offer benefits are not approved for purchase by the NHS.

While privately-bought tests are an increasingly important part of the industry, BIVDA firmly believe that the answer to this question is better adoption and use of diagnostics by the NHS – meaning everyone can access these life-saving and life-improving tests, free, and at the point of need.

BIVDA Chief Executive Helen Dent says, “There is an important difference between screening tests – which certain parts of the population are eligible for check for signs of illness – and those which are conducted on a patient who has gone to a medical professional with symptoms.

"We would urge anyone who is offered a screening test to participate, and be confident that our industry has the safety of patients at the forefront of all we do. If you do choose to buy a test to use at home, read the instructions carefully and if in doubt, speak to your healthcare provider.”

BIVDA’s Director of Policy and Programmes, Paul Fisher says, “Before joining BIVDA, I delivered major diagnostics programmes for the UK government. Testing at home was a key part of the UK’s response to COVID-19 and continues to be a vital part of our health system.

"Patients should be reassured that at-home testing delivered by the NHS is safe, accurate, and saves lives. Private testing does offer the ability for patients to take ownership of their own health – but do check the test carries a UKCA or CE mark to make sure it is approved for use.”