BMJ Studies Raise Concerns About How Customers Interpret Self-Test Accuracy Claims.

Customers who purchase home testing kits from a pharmacy generally take the results on trust. There isn’t a huge amount of brand discernment in the self-testing kits market – i.e. customers tend simply to purchase whatever products are available in their pharmacy of choice. All are implicitly assumed to be accurate and reliable – but is this always the case? Two 2023 University of Birmingham-led studies of direct to consumer home testing kits sold in the UK, published in the British Medical Journal (BMJ) in July 2025, looked into the information provided with self-test kits sold in pharmacies, supermarkets, and health and well-being shops. One study reviewed whether the instructional information and promotional material itself supported informed decisions, and a linked study examined the accuracy of the vendor’s performance claims.

What was the verdict?

The first study reviewed the information supplied with 30 self-tests covering 19 conditions and assessed whether or not customers were given enough guidance on when to use the test, how to interpret the result and what to do afterwards. The second study assessed the evidence behind a range of test performance claims, including accuracy, sensitivity and specificity, as well as regulatory requirements, equipment safety, usability, interpretability and readability. The researchers found that many tests gave customers ‘limited information for informed use’, that some high accuracy claims were difficult to verify from publicly available evidence, and that 18 of the 30 obtained tests were considered “high risk” because of concerns around equipment, sampling, instructions or interpretation.

A wake up call for UK pharmacies

Although the studies didn’t target pharmacies exclusively – supermarkets and other retail outlets were also covered – the results have been a wake-up call for many community pharmacies. This is because a self-test sold in a pharmacy carries a level of assumed credibility. Customers do not see it as just another retail item; they are likely to treat the result as health information they can act on. If the test instructions are weak, the accuracy claim is poorly explained, or the next-step guidance is unclear, the pharmacy may be left dealing with the consequences: a customer reassured by a result that does not fit their symptoms, or alarmed by a result they do not know how to interpret.

This is the real warning in the studies. The concern is not that every home test is unreliable – far from it. The crux is that a test can be legally sold, neatly packaged and confidently marketed while still giving consumers too little information to use it well. University of Birmingham coverage of the studies reported that accuracy claims were made for 24 of the 30 tests purchased, with 14 of those 24 claiming ‘at least 98% accuracy’, sensitivity or specificity; it also noted that supporting evidence was often unavailable or insufficient for likely purchasers to judge the claim properly. Their conclusion was that stricter regulations are needed to address concerns surrounding over-the-counter self testing kits.

While this may or may not be the case, there are things that pharmacies can do to strengthen accuracy and quality on the shop floor.

What pharmacies should check before stocking a self-test

The first question is not whether the product has a strong headline claim, but whether the vendor can explain what the test is intended to detect, who it is intended for, what sample is required, when the sample should be taken, how the result should be read, and what the customer should do after a positive, negative or invalid result.

Accuracy should also be checked at the product level – a pharmacy needs to know whether the performance claim relates to analytical accuracy under controlled conditions, comparison with a suitable reference method, or anecdotal real-world use by members of the public. These are all very different claims – something which may be obvious to a trained pharmacist or medical professional, but not so much to a member of the public. Claim evaluation should also account for the fact that a test may perform well in controlled conditions but fail to deliver results if the user instructions are hard to follow, the result window is easy to miss, or the limitations are buried in small print.

This is why evidence-based stock selection is so important for pharmacies when sourcing home testing kits. A suitable self-test line should come with accessible instructions for use, defined limitations, a clear intended purpose, support for customer questions, and supplier accountability if a product query or complaint arises.

Find out more

Our Suresign range supports pharmacies with evidence-based home-testing products designed for a range of common customer concerns, including pregnancy, UTI and health-check categories. Speak to us today about stocking self-testing kits that give customers a practical first step in their health journey, while supporting pharmacy teams with the product information needed to explain correct use, result limits and onward advice.