WHAT'S NEW - COVID-19 Rapid Testing
COVID-19 Rapid Testing
The Government announced two rapid tests yesterday which are to be deployed initially in health and social care settings but after a number of false dawns this would appear to make testing on set an option.
Indeed the Government press release says “the tests do not require a trained health professional to operate them, meaning they can be rolled out in more non-clinical settings” but as ever the devil is in the detail and there are some obstacles to navigate.
On initial reading, these do look promising but it is likely they will be hard to source outside the NHS / social care settings at least for the time being. Also because these tests fall within the legal definition of ‘diagnostics and screening’ they will need to be taken, processed and results given by a medic / nurse / professional under the aegis of a registered healthcare provider. More on that below – but unless there is a change to the law it’s difficult to see how these could be undertaken without medical supervision.
Are they accurate?
The raw data on these tests has not been released as yet but the DNA Nudge test cites sensitivity of 98% and specificity of 100% - which is good.
LamPORE are being coy about their numbers for now but if we look back to the PR nightmare the Government had over tests purchased from China early on that turned out not to be accurate it’s unlikely these are duds. Both tests have been evaluated in clinical situations for some time; we just don’t have the actual test data yet.
Also in a previous bulletin we pointed out that if the testing is regular and rapid sensitivity / specificity aren’t so important. Rather than rehash previous bulletins on testing, let’s get stuck in to the operational details.
Companies can’t just put any old test on sale. This is a highly regulated marketplace for obvious reasons. Tests for use in medical settings need rigorous testing and CE marking. Some tests (and any used outside healthcare) need to be authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
• EU Directive 98/79/EC on in vitro diagnostic medical devices (IVD) applies to COVID-19 tests. In order to place these tests on the EU market, the manufacturer has to jump through a bunch of very specific hoops that ultimately result in their being able to put a CE mark on the IVD. Then such tests can be used by healthcare professionals only. (At national level, governments can waive the CE requirement on a device-by-device basis as has happened with DNA Nudge).
• All other devices are classed as ‘self-testing’ and require the involvement of a ‘notified body’ (MHRA in the UK) which carries out additional verification of the technical documentation. Currently the MHRA hasn’t authorised any test to be used outside a clinical setting.
What is ‘clinical’ or ‘professional’ use?
The MHRA defines professional users as:
“persons using the medical device in the course of their work and in the framework of a professional healthcare activity”
The definition of a Schedule 1 of the Health and Social Care Act (H&SCA) 2008 (regulated activities) regulations 2014 also define a “health care professional”
“means a person who is— (i) a medical practitioner, (ii) a dental practitioner, (iii) a dental hygienist, (iv) a dental therapist, (v) a dental nurse, (vi) a dental technician, (vii) an orthodontic therapist, (viii) a nurse, (ix) a midwife, (x) a biomedical scientist, (xi) a clinical scientist, (xii) an operating department practitioner, (xiii) a paramedic, or (xiv )a radiographer;” (these are the main ones).
So these tests need to be carried out by a medic of some flavour or other. And you’d probably want that because even though both these tests are easier to perform (saliva samples) it’s quite difficult to find detectable amounts of virus early in an infection. You don’t want that hampered by poor sampling technique.
The other issue is this is ‘diagnostics and screening’ which is a “Regulated Activity” under the H&SCA. To quote the Care Quality Commission (CQC) who regulate this:
“The activity includes instances of taking a sample or biopsy because it captures procedures if they involve removal of tissue, cells or fluids from the body, for the purpose of diagnosing disease, disorder or injury or monitoring its cause or extent. Therefore, anyone who 'removes' tissue, cells or fluids from the body for diagnostic reasons must register.
The activity also includes anyone who uses equipment to examine tissue, cells or fluids from the body to obtain information on the cause and extent of a disease, disorder or injury. If the provider removing the sample is the same provider who is carrying out the examination then this may be included within a single registration; if a remote contractor is used for diagnostic analysis, such as a laboratory company, the analysis will also require registration in its own right.”
There are exclusions but none is relevant for our purposes (save that if someone is registered for another activity they don’t need to register separately for D&S for samples like swabs). There is also the interpretation of individuals’ results. Granted, these tests are designed to be simple to use and give (almost) a binary ‘computer says yes / no’ answer but if someone tests positive they will have questions that will need answering by someone trained to do so. This is one of the principal reasons such tests fall within the regulated activity of diagnostics and screening, and why statute puts them firmly in the domain of medically trained professionals.
There are other aspects of CQC oversight that apply but be in no doubt – this is a Regulated Activity within the H&SCA and as such anyone involved in the taking and processing of samples and the communication of results needs to be doing it on behalf of a registered provider and be qualified / a member of whichever statutory body regulates their profession from the list above.
This is why “the tests do not require a trained health professional to operate them, meaning they can be rolled out in more non-clinical settings” is mistaken and likely slightly over enthusiastic PR. In fairness in the Government PR it does mention hospitals and care homes too – and both are Regulated Activities. Yes, the test is simple to perform - you plug in the cartridge and press a button and it flashes green or red but it’s still a Regulated Activity because it’s diagnostics and screening.
This is distinct from physiological measurement such as blood glucose stabbers for diabetics, blood pO2 meters you stick on your finger or a pregnancy test. These are not diagnostic tests – they are not being used to diagnose an illness, they are taking a measurement. Also a pregnancy test is not technically ‘diagnosis’ as – despite all the attempts to medicalise it – pregnancy is not an illness.
Even if the MHRA did grant a Marketing Authorisation for home use – which may happen in the future – it is difficult to see see a way around the H&SCA / CQC ‘diagnostic and screening’ issue unless it goes through parliament. We shall continue to watch with interest.
We think this is a positive development and very welcome - but it is likely availability might be the limiting factor, certainly to start with. Also as the law stands at the moment it seems clear that these tests need to be conducted under medical supervision for the reasons stated above.