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Why self-test kit suppliers must provide access to professional customer support
Friday 23rd September 2022
Dr John Rees
In an ideal world, medical self-test kits would be provided to patients by their doctor or a pharmacist, who would also be in a position to provide advice about how to use the test and interpret the results. However, difficulties getting GP appointments, time constraints during consultations, the funding system for NHS diagnostics in primary care, and subsequent delayed referral for laboratory tests, means that this is unworkable.
Current medical device regulations stipulate that manufacturers of self-test kits must perform user trials with laypersons to show that the majority of people can perform the test and interpret their results correctly. Nevertheless, it is inevitable that a small, but important, proportion of users will, despite their simplicity, misinterpret the instructions, or will need some reassurance that they have performed the test and interpreted the results correctly, particularly as some self-test kits address serious health matters. For these reasons, users of self-test kits should have simple access to a timely, competent customer support team, with the necessary scientific or clinical knowledge to provide professional help and advice when needed.
In contrast to most consumer products, medical self-test kits could be better positioned as a combination of test and service (advice), although it is unlikely that all suppliers will have the necessary expertise. Due to the nature of these products, and the user's need for reassurance that they have used a test and interpreted the result correctly, access to a helpline or online chat is just as important as the quality of the test device itself. This goes further than just the statutory requirements on manufacturers of self-test kits to provide contact details within the instruction leaflet, but also to have a team of competent, scientific or clinical staff, with the necessary expertise and experience, to provide on-the-spot accurate and professional help to users.
Nevertheless, this should not go as far as providing medical advice. It is important to stress that an in-vitro diagnostic test result in isolation, whether performed at home with a self-test kit or by a hospital laboratory, must be considered together with the patient's clinical history performed by their doctor. It is also a UK and EU regulatory requirement that all self-test users must be advised to discuss their self-test result with their doctor or pharmacist before making any changes to medication or lifestyle.
In conclusion, suppliers of self-test kits should see the provision of a professionally staffed helpline, who understand the concerns and needs of self-test users, as being integral to the provision of the self-test device itself.
SELFCHECK self-test users are supported in the UK by a customer care team of scientific and regulatory professionals that provide help and advice, with expertise in the design and development of lateral flow rapid test technology and the development of medical diagnostics for research and clinical use in hospital laboratories. For further information, please see www.selfchecktests.com