We recognise that it is essential that self-test users are provided with the information they need to decide whether self-testing is appropriate for them, and also that they receive the relevant aftercare to allow the self-test user to understand the meaning and consequences of their test result. Ideally, patients with symptoms should speak with their pharmacist or GP, before considering using a self-test kit.
Whilst we agree that GPs should not be expected to endure the burden of interpreting and discussing reams of multiple test results from non-symptomatic health screening tests, from private laboratories, with their patients, clinicians should be aware that it is a requirement of current UK legislation for manufacturers of biomarker specific self-test kits to clearly direct users to speak with their doctor to discuss their test result before taking any decision of medical relevance (1).
With reference to the recent RCGP Position Statement on Non-Symptomatic Self-Tests (2), we also agree that self-test manufacturers and suppliers should, where appropriate;
- provide impartial information on the pros and cons of self-testing
- explain the evidence base for the use of a specific biomarker for a particular disease with reference to national guidelines, and their relevance
- produce impartial information to allow the patient to appreciate whether or not a specific self-test is relevant to them, including the risks and benefits of testing
- show a proven benefit and usefulness to patients for testing for a specific biomarker, when used appropriately, and explicitly explain whether the test is available by the NHS, and if not why not
- supply only devices that have been independently evaluated and certified by Notified Bodies, who are responsible to the UK’s competent Authority (MHRA)
- maintain the internationally recognised Quality Assurance System for the design, development, manufacture and supply of medical devices (ISO13485:2016) applied in the context of current UK legislation (IVDD/IVDR), independently and externally audited by UKAS accredited auditors
- provide resources to explain what the results mean to the user, ensuring that the information is clear and specific
- provide further resources for the self-test user on how to interpret the results in the context of a specific disease and explain the consequences of a false positive or negative result
- provide appropriate aftercare, including expert advice on the interpretation of the results and signposting to clinicians when required
The SELFCHECK self-test concept is quite different to self-testing services provided by private laboratories, where blood samples are collected by the patient and then posted for screening against a large panel of biomarkers.
In contrast, each SELFCHECK test detects a single, specific, established biomarker and provides a result within 10 minutes, using immunochromatographic (lateral flow) or biochemical methods. Most of the same devices have been used in a healthcare setting for over 15 years. Full information is provided with each test on what the test does and what the result will mean to the user. Additionally, SELFCHECK users also have access to expert UK support who can assist with using the test, and appropriate signposting.
All SELFCHECK medical device components are manufactured in the EU and assembled in the UK according to EU and UK law (IVDD/IVDR), in ISO13485:2016 certified laboratories. These are the exact, same regulations and performance requirements that apply to diagnostics used in NHS hospital laboratories.
Currently, under the IVDD regulations, almost all diagnostics used in NHS hospital labs do not require independent evaluation by Notified Bodies, but are self-certified by the manufacturer. This is in contrast to self-testing kits such as SELFCHECK, which all have to be independently evaluated including diagnostic performance and usability by laypersons. The forthcoming IVDR will replace IVDD and will require all diagnostics, including those used in hospital labs to be independently evaluated by Notified Bodies such as BSi, MDC, TUV etc.
The instructions-for-use provided with each SELFCHECK test provides clear information, written in simple English, as to what the test is for, its limitations and how to interpret the results. The key information provided with each test is independently evaluated by Notified Bodies that are appointed by Competent Authorities. The UK Competent Authority is MHRA.
SELFCHECK products already meet the key requirements for quality assurance of medical diagnostics, according to current UK and EU legislation (IVDD/IVDR). Nevertheless, we recognise that potential users may benefit from additional information, so that a more fully informed decision can be made before deciding whether to use a specific test, together with appropriate aftercare and signposting.
We anticipate that this review will be completed by the end of Q2, 2023 and information updated promptly thereafter. We welcome constructive input from stakeholders.
1. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Annex I, Section 8.7(t)