Strict regulations needed to address off-the-shelf health test concerns

Off-the-shelf health tests need much greater regulation due to significant concerns over claims and the suitability of the tests for the public, a landmark study has found.

In a series of papers published by The BMJ, researchers from the University of Birmingham funded by the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre have reviewed a range of commercially available health tests purchased from shops. The research team conducted the study of self-tests following concerns that directions for use, usability of equipment, and incorrect interpretation of results could cause harm.

Thirty self-testing kits were purchased that were stocked by the mainstream supermarkets, pharmacies and health and wellbeing shops, ranging from tests for vitamin deficiency, blood cholesterol, menopause and bowel cancer. Accuracy claims were made for 24 of the tests, and most (14/24; 58%) claimed a performance of at least 98% accuracy, sensitivity or specificity. However, evidence supporting accuracy claims were largely unavailable or didn’t provide sufficient information for people likely to purchase these tests.

Where information about the methods used to estimate test accuracy was available in Instructions for Use leaflets (17/30 tests), the accuracy of five tests (5/17; 29%) was evaluated against a similar test rather than a more reliable and accurate test. In addition, the descriptions of participants involved in these studies was mostly lacking, preventing an assessment of the relevance of accuracy estimates to the general public.

The study also highlights issues with the usability and safety of tests, with 18 self-tests being flagged by the research team that could lead to an erroneous result or action. The team also identified:

• 11 tests with problems in the equipment,
• 10 with problems in the sampling process, and
• 15 with problems in the instructions or the interpretation of the results.

Researchers involved in the study are now calling for better regulation and guidance for manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.

Professor Jon Deeks at the University of Birmingham and corresponding author of the study said:

“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.

“Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves. In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.

“Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”

Dr Clare Davenport, Clinical Associate Professor at the University of Birmingham and co-author of the study said:

“The wide range of off-the-shelf tests now available to the public are not endorsed by the NHS and evidence for their benefit is lacking. This is in contrast to well-established self-tests, such as pregnancy tests.

“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way”

Tests should be evaluated by people

New medicines or interventions must undergo a stringent regulatory process, including clinical trials and registration with the MHRA. In contrast, medical self-test devices are subject to less stringent checks by Notified Bodies, and this has allowed certain self-tests to be sold in the UK, despite them raising concerns.

New regulatory standards should ensure better reporting of studies of self-tests to support transparency of test claims, according to the research team. The researchers also assert that more emphasis should be placed on ensuring the clinical studies of self-tests are conducted appropriately. In particular, self-tests should not only be tested in laboratories, but they should also be evaluated by the people and for the purposes for which they are intended to be used.

Dr Clare Davenport 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 said:

“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.”