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Researchers from the University of Birmingham have recommended updating regulations so that some ‘off the shelf’ health testing kits can only be bought under the supervision of a pharmacist. 

The UoB researchers reviewed a range of commercially available self-use health tests from pharmacies, supermarkets and other shops, including tests for bowel cancer, blood cholesterol, menopause and vitamin deficiency.

They identified numerous issues with the self-test kit market, including the fact that while 14 or the 24 sampled products “claimed a performance of at least 98 per cent” for accuracy, sensitivity or specificity, evidence to back this up was “largely unavailable”. 

For some tests that did set out the methodology behind their claims, many had been tested against similar products rather than more reliable and established tests.

Eighteen were flagged as having usability issues that could lead to a false result, including 11 tests where there were problems in the equipment, 10 where there sampling process problems and 15 where there were issues with either the instructions or the interpretation of results. 

The research team argued that self-test kits should be subjected to more stringent regulatory checks and be required to show more transparency around how efficacy claims have been made. 

The tests "should not only be tested in laboratories" but also "by the people and for the purposes for which they are intended to be used," they said. 

Dr Clare Davenport, a UoB academic who co-authored the paper, said: “The same consideration given to pharmaceuticals should be given to self-testing where some, such as pregnancy tests, could be sold over the counter and others that carry greater risk of misuse are sold only with the support of a pharmacist. 

“These latest studies have also shown that information and data that support claims of accuracy, specificity or sensitivity needs to be available to the public.”

Professor Jon Deeks added: “A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.

“Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers. 

“Several of the self-test manufacturers refused to provide us with reports of their studies, which support their claims, stating that they were ‘commercially confidential’. 

“Legally, they do not need to share this information. However, for all matters of our health, it really is important that the evidence upon which health decisions are made is available and can be scrutinised.”