Agreement: I Agree Body: Dear Editor Coombes' report usefully frames the MHRA proposals as a patient safety response to a rapidly expanding market in direct-to-consumer self-tests.[1] The point that now needs sharper regulatory attention is narrower: when a person buys such a test, the product should make clear who is expected to interpret the result and who carries responsibility for the next step. The linked BMJ studies make this more than a matter of improved wording on a packet.[2,3] Many tests did not provide basic information on appropriate users, interpretation of results, or subsequent action. Coombes' report also records the downstream effect already seen by professionals: people take results to GPs or laboratories asking what they mean, with stress, anxiety, and sometimes unnecessary referral.[1] A test that relies on this informal clinical backstop is not functioning as a self-contained consumer product; it is opening an uncommissioned route into a diagnostic pathway. That is the gap the proposed regulations should close. Removing misleading or unsubstantiated claims will deal with part of the market failure, but it may still leave products whose downstream consequences are not assigned to any accountable pathway. Tests marketed for reassurance or early detection are particularly vulnerable to this problem: a positive result may prompt consultation of uncertain value, while a negative result may provide reassurance that is not clinically warranted. The MHRA's impact assessment should therefore ask a specific implementation question: for higher-risk direct-to-consumer self-tests, what clear and auditable post-test pathway is required before market access, and who is accountable for providing it?[4] At minimum, such products should provide plain-language absolute-risk interpretation and a defined follow-up route that does not simply default to NHS general practice. The objective is not to impede useful self-testing. It is to prevent commercial self-testing from becoming informal screening with publicly funded aftercare. References 1. Coombes R. Health self-testing kit crackdown: tougher regulations set to remove harmful products from the UK high street following BMJ studies. BMJ 2026;393:e410896. doi:10.1136/bmj-2026-410896. 2. Davenport C, Richter A, Hillier B, et al. Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of information on intended use, instructions for use, and post-test decision making. BMJ 2025;390:e085546. doi:10.1136/bmj-2025-085546. 3. Hillier B, Deeks JJ, Alderman J, et al. Direct-to-consumer self-tests sold in the UK in 2023: cross sectional review of regulation and evidence of performance. BMJ 2025;390:e085547. doi:10.1136/bmj-2025-085547. 4. Medicines and Healthcare products Regulatory Agency. Pre-market medical devices regulation-stakeholder impact survey. GOV.UK. Published 11 May 2026. No competing Interests: Yes The following competing Interests: Electronic Publication Date: Sunday, May 24, 2026 - 05:02 AI use: No, I have not used AI Highwire Comment Subject: Health self-testing kit crackdown: Tougher regulations set to remove harmful products from the UK high street following BMJ studies Workflow State: Released Full Title: Self-tests need accountable follow-up pathways Highwire Comment Response to: Health self-testing kit crackdown: Tougher regulations set to remove harmful products from the UK high street following BMJ studies Check this box if you would like your letter to appear anonymously:: Last Name: wu First name and middle initial: Xiaojuan Email: xiger6666@126.com Address: Ganzhou, Jiangxi, China Occupation: Physician Affiliation: Ganzhou People’s Hospital, Ganzhou, Jiangxi, China BMJ: Additional Article Info: Rapid response