The Medical and Healthcare products Regulatory Agency (MHRA) of the UK has updated the information dedicated to tests and testing kits intended to detect the COVID-19. The information describes how the different types of COVID-19 tests operate and provides specifications to be used by the medical device manufacturers and other parties involved.
MHRA COVID-19 Tests Guidance for Patients and Healthcare Professionals
The first guidance published by the MHRA is intended to provide additional information on coronavirus tests and test kits to the patients and healthcare professionals.
First of all, the agency names existing types of COVID-19 tests and describes the difference between them. According to the document, the following types of tests could be used:
- Virus (antigen) tests – ones used to check whether the patient subject to examination is currently infected. For this purpose, the swab should be taken from the patient`s nose and throat.
- Antibody tests – ones used to identify the antibodies indicating that the infection was present in the past. For this purpose, a blood sample should be taken. At the moment, these tests are available only to healthcare personnel or patients. The tests of this type are mostly used to track the spreading of the infection, but not for actual diagnosing purposes.
Irrespectively of the type, all COVID-19 tests require the samples to be examined. These samples should be taken from the patient suspected to be infected with coronavirus disease and then examined in the accredited laboratory entitled to perform such tests. For this purpose, a special sample collection kit is needed. According to the current regulation, any sample collection kit which constitutes a part of the COVID-19 test should be properly marked with a CE mark indicating that it meets the applicable safety and performance criteria. Depending on the type of the kit, the sample could be collected either by the patient himself/herself or by healthcare professionals.
In the case of antigen tests, a swab collected from the throat is used to detect the genetic material from the virus. In order to expand the availability of the COVID-19 tests, the UK government has already launched a special program allowing anyone who has symptoms to get a self-sampling kit that could be used to collect the samples as described above.
In most of the cases, the samples for antibody tests are being collected by healthcare professionals.
The MHRA additionally emphasizes the importance of following the instructions for use accompanying the COVID-19 tests in order to ensure the accuracy of the results achieved. For instance, any mistakes in the collection of samples could result in incorrect test results. The authority also encourages the patients to contact the test manufacturer in case of any doubts, and also to inform the authority about any tests that do not operate properly.
Self-Test COVID-19 Kits: Regulatory Approach
It is also important to mention that there is a quite specific category of COVID-19 tests – the self-test kits. Using such kits, a customer can carry out the whole process himself, starting from collecting the samples and up to performing the test and interpreting the results received. In this case, there is no need to transfer the sample to the laboratory for further examination since the procedure could be performed by the customer without the need to engage healthcare professionals.
At the same time, there are no COVID-19 self-test kits allowed to be marketed and used in the UK. Moreover, it is strictly prohibited to make such tests available to the customers due to the fact that still there are no self-test kits properly marked with a CE mark. At the same time, a self-test COVID-19 that would be CE marked would be also allowed for marketing in the UK.
Limitations of Tests and Test Kits
The MHRA reminds us that any tests are not 100% accurate and reliable, so it is important to keep in mind that some errors or mistakes may occur. According to the guidance, mistakes could take place due to the issues related to:
- failure to follow the instructions for use when collecting the samples,
- failure to transport the samples in accordance with the procedure described by the manufacturer,
- mistakes occurred when performing the test,
- incorrect interpretation of test results.
Certain specific limitations are associated with antibody tests: due to the limited information about the immunity to COVID-19, it is still unknown whether antibodies could protect one from infecting or passing the virus. It is also unclear whether the negative antibody test could actually confirm that the person subject to testing is not infected.
As it was already mentioned before, antibody tests are currently available mostly to healthcare professionals or patients of hospitals and other healthcare institutions, and also could be purchased by private persons. Virus (antigen) tests are available under special governmental programs.
In accordance with the applicable regulation, COVID-19 tests and test kits should be treated as medical devices. Thus, both the test itself and the sample collection kit should be CE-marked in order to be allowed for marketing and use in the UK. Such a marking could be placed on a medical device upon its registration with the regulating authority.
COVID-19 Tests Guidance for Manufacturers
Another guidance document issued by the MHRA is intended to provide additional information and clarifications to medical device manufacturers. For this purpose, the authority has developed Target Product Profiles (TPPs) intended to assist in designing and developing COVID-19 tests compliant with the applicable requirements. TPPs describes the criteria to be applied for tests and test kits. However, MHRA states that these criteria are not mandatory. The Target Product Profiles employ the information the authority has nowadays, while the authority reserves the right to amend them in case it would be reasonably necessary.
In order to be allowed to market their COVID-19 tests in the UK, the manufacturers shall make claims regarding the performance of the devices. Such claims could include, inter alia, the following ones:
- analytical sensitivity,
- diagnostic sensitivity,
- analytical specificity,
- diagnostic specificity,
- reproducibility, including control of known relevant interference,
- limits of detection.
According to the guidance, the aforementioned claims should be based on the evaluation data properly collected by the manufacturer in the course of clinical trials. Before commencing such trials, the manufacturer should apply for the registration of the device for performance evaluation – a device initially intended to be used for the studies to be conducted in laboratories or another suitable environment.
Summarizing the information provided here above, the guidance documents on COVID-19 tests and test kits published by the MHRA cover the most important aspects related to the tests intended to detect the coronavirus. The documents describe the approaches to be used by customers (patients) and medical device manufacturers in accordance with the applicable regulations.
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