The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel coronavirus”).
TPP is a special document issued by the MHRA to describe the required features of the medical device intended to address a specific disease(s). In general, the target product profile covers such aspects as the intended use determined by the medical device manufacturer, the targeted population, and also the additional characteristics of the device related to its safety and performance. The documents of this type are intended to provide medical device manufacturers with additional information to be considered with regards to the characteristics the device shall have to be used for the intended purpose. Thus, the TPP usually outlines both preferred and minimally acceptable profiles of the medical device depending on its intended purpose, alleged use environment, and intended users. The authority also emphasizes that the TPP could be subject to additional review and revision on the basis of the new information received from scientific evidence.
COVID-related Target Product Profiles
The present document has been developed by the MHRA to address the matters related to the outbreak of COVID-19 caused by the virus SARS-CoV-2 or the “novel coronavirus.” In this context, it becomes especially important the extent to which the particular product meets the applicable characteristics in order to ensure its safety and effectiveness when being used for the intended purpose. The MHRA also states that in case of any deviations made to the device, such deviations should be duly justified, while the medical device manufacturer would also have to demonstrate that such deviations do not affect the performance of the device.
According to the document, point of care tests (POCT) are playing the important role in addressing COVID-related factors since they allow to accelerate the identification of the infected patients. The tests of this type are based on the analysis of a sample of bodily fluid in order to determine the presence of viral nucleic acids or antigens. Moreover, in certain cases, such tests could be also used outside the clinical environment. Thus, in general, they should comply with the safety requirements and provide accurate and reliable testing information within a relatively short period of time.
The tests covered by the scope of the present TPP are intended to triage the infected patients on the basis of the information on SARS-CoV-2 nucleic acids or antigens to be provided by the tests. The triage process stands for dividing the patients into certain groups depending on the severity of the disease and intensity of the treatment required. Such a process allows healthcare professionals and care providers to focus on patients who require the most attention.
The MHRA also outlines the POCT that are intended for other purposes and thus are actually falling outside the scope of the present target product profile. Such COVID-19 tests include, inter alia, the ones intended to:
- Obtain confirmation of the initial diagnosis,
- Make any prognosis regarding the expected outcomes of the disease,
- Make any predictions regarding the way the organism of the patient would actually respond to the treatment,
- Distinguish the novel coronavirus from other similar pathogens,
- Supplemental laboratory tests,
- Self-tests intended to be used directly by the patients (laypersons).
As it is stated by the MHRA, the products for the use cases described hereabove are requiring separate target product profiles due to the specific characteristics such products should meet.
SARS-CoV-2 Tests Clinical Performance Requirements
The most important section of the document issued by the MHRA is dedicated to the requirements for COVID-19 tests related to clinical performance. In particular, the requirements described by the MHRA are based on the «minimally acceptable» approach due to the public health emergency. Hence, the tests failing to meet the requirements indicated in the present target product profile would be not allowed to be marketed in the UK.
According to the general rule, compliance of the test in question with the minimally acceptable requirements is determined depending on whether it meets the acceptance criteria in the terms of clinical sensitivity and specificity. At the same time, the authority states that the applicable requirements could change depending on some aspects related to the future use of the tests. For instance, the MHRA expresses the position that for some groups of target populations the sensitivity and specificity characteristics should be different. In order to assist medical device manufacturers and other parties involved in the actual implementation of the requirements, the MHRA also provides special tables to be used in supporting the decision-making process. According to the document, in certain cases, it is allowed to use the test with lower sensitivity and specificity thresholds but rapid performance together with the more accurate but relatively «slow» test to get an additional confirmation in order to avoid negative consequences of the incorrect determination in the context of triage.
The MHRA also mentions that the acceptance criteria used in the present target product profile are actually based on the appropriate TPPs developed and published by the World Health Organisation for in vitro diagnostic devices intended to be used in the context of other diseases.
Additional Aspects to be Considered
The MHRA additionally emphasizes that the required characteristics of the COVID-19 tests, and also the present target product profile indicating the current applicable requirements could be subject to changes and amendments in case of new information about the COVID-19, response measures and the virus itself will be found. According to the document, the disease is continuously changing, so its diagnosis and treatment should be changed accordingly. Thus, each time considering the options related to the test, the industry representatives shall duly ensure they are using the latest version of the TPP.
Among the changes the authority expects to take place, the most important is related to how the tests should be used. In particular, it is expected that the availability of reliable and accurate tests intended to be used by laypersons would increase. Nowadays the manufacturers are developing in vitro diagnostic medical devices that could be effectively used by patients having no experience or professional background themselves.
Another important point included in the document relates to access to the panel of samples. According to the MHRA, it could be useful for the following purposes:
- Samples could be used for calibration purposes, and also to assess the analytical performance of the tests.
- Samples could be also used to assess the actual effectiveness of the tests when used for the particular target population.
Summarizing the information provided here above, the present MHRA target product profile on SARS-CoV-2 tests outlines the minimally acceptable requirements the in vitro diagnostic medical devices should meet in order to be allowed for marketing and use in the UK. The document also emphasizes the important aspects to be considered by the medical device manufacturers and other parties involved with regard to the safety and performance of the tests, including the requirements related to the sensitivity and specificity, and also the particular conditions under which such requirements could be changed.
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