Self-tests (devices for self-testing) and near-patient tests have become an important aspect of healthcare, and not just since the coronavirus pandemic. However, there are still several uncertainties regarding their use: are the devices designed clear enough for laypersons to be capable using them correctly? Can they withstand ambulance and emergency room conditions?
This article will explain:
Self-tests (also “devices for self-testing”) and near-patient tests (also “point-of-care testing,” POCT) have a lot in common and are therefore treated similarly from a regulatory perspective.
Self-tests are predominantly used by laypersons in their own home. They take the sample themselves and also perform the analysis on the spot using the self-test.
Classic examples of this type of test are home pregnancy tests, cholesterol tests and coronavirus self-tests.
‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to laypersons by means of information society services
Source: IVDR Art. 2(5)
The “information society services” referred to in the IVDR’s definition would include, for example, apps that patients send the values measured with a self-test (e.g., hormones in saliva or urine) to and that then provide a recommendation for action based on the analysis of this data. The app could, for example, interpret longitudinal trends (e.g., state whether the patient is currently fertile or whether short-term or long-term insulin would be better right now). The app would then be considered an “information society service” and the software would be classified as a “device for self-testing.”
A near-patient test is in many cases similar to a self-test from a technical and use point of view. However, they are performed by medical professionals and not laypersons.
Unlike most self-tests, a lot of near-patient tests require an analytical device that is easy to use but involves complex technology. In most cases, they are not only too complex for laypersons to use, they are also very expensive to purchase.
Other near-patient tests use a pre-prepared test kit that is like a self-test. However, the sample is taken by a medical professional, e.g., a physician, paramedic, etc., and not by the patients themselves. Medical professionals also perform the analysis of the sample in the case of near-patient tests.
Examples would include rapid coronavirus tests in test centres or blood gas analysis in an emergency room or neonatology department, or CRP tests at pediatric centres to determine whether a child has an infection.
Trillium Verlag has compiled a list of POCT systems that require an analytical device.
‘device for near-patient testing’ means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional
Source: IVDR Art. 2(6)
In the case of sampling kits, the sample is normally taken by a medical professional (as with near-patient tests) in, for example, a primary care centre and in exceptional cases by the patient themselves (as with self-tests). Unlike self-tests and near-patient tests, with a sampling kit the analysis is not performed on the spot. Instead the collected sample is sent to a medical laboratory that performs the actual diagnostic testing.
Therefore, the main difference is in the analysis: in the case of self-tests and POCT, it is done on the spot. In the case of the sampling sets, the analysis is performed by a centralized laboratory.
While self-tests and near-patient tests have a lot in common from a regulatory perspective, this is not the case for sampling kits. From a regulatory perspective, they are treated very differently from the other two test kit forms.
Examples of self-tests, near-patient tests and sampling kits based on SARS-CoV-2 tests:
There are several regulatory requirements that apply to both self-tests and near-patient tests, and a few that apply to only one type of test.
The regulatory requirements for the two types of test can be found in EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR).
As self-tests and near-patient tests are used in situ and not in a controlled laboratory environment, specific usability requirements have been defined for the tests (see, e.g., Annex I 19 IVDR). This is particularly true for self-tests used by laypersons.
According to Annex I 20.1(e) IVDR, each device must come with instructions for use. So, if a multipack contains 10 tests, each of these tests must come with a copy of the instructions for use, rather than just one copy of the instructions for use being provided for the entire multipack. This is still the case even if multiple devices are supplied to a single user. In addition, the instructions for use must identify the intended user (Annex I 20.4.1(e) IVDR).
There are specific requirements governing the labelling of the devices as well:
The focus on usability is also reflected in the application for assessment of the technical documentation (TD) by a notified body. Therefore, according to Art. 48(3), (7) and (9) and Annex IX 5.1 IVDR, the assessment of technical documentation must be requested separately and usability studies must be included with the application. The technical documentation must also contain evidence that laypersons or medical professionals can use the device under stress in any circumstances (Annex II 3.1(e) IVDR).
Similarly, according to Annex X 2 IVDR, the same applies to applications for conformity assessment by a notified body on the basis of a type examination. They should also include:
According to Annex VI 2.14. IVDR, self-tests and near-patient tests must be registered in the EUDAMED database as devices for self-testing or for near-patient testing.
The following requirements apply to self-tests in addition to the ones mentioned in section a):
Labelling and instructions for use
The following additional requirements also apply to the instructions for use that accompany self-tests:
Self-tests (devices for self-testing) fall into class C according to Annex VIII 2.4.(a) IVDR. Exceptions are:
These fall into class B.
In the clinical performance study plan (Annex XIII 2.3.2 IVDR) manufacturers must provide information on where a clinical performance study will be conducted and the number of laypersons involved. In the performance study (see Annex I 9.4(a) IVDR) it must be shown that laypersons can derive the correct conclusions from the test results.
The specific requirements for near-patient testing defined in the IVDR relate to their classification: devices intended for near-patient testing are not all assigned to a single class (as is the case with self-tests). Instead, they must be classified according to their intended purpose (Annex VIII 2.4.(b) IVDR).
For further research, we recommend the book Point-of-care testing: Principles and Clinical Applications by Peter B. Luppa and Ralf Junker (editors), 3rd edition.
We have the following tips for you to help your self-tests and POCTs get through the conformity assessment process without any difficulties:
The definition of the intended purpose needs to be clear for the performance evaluation.
There is a big difference between whether a test is used to detect a biomarker or to exclude it.
In the case of detection, the assumption is that the patient is positive (symptoms or risk group). In the case of exclusion, it is assumed that the patient is healthy. Performance evaluation criteria are derived from these assumptions: firstly, the criteria that determine whether a patient is a candidate for the test or not and, secondly, the acceptance criteria for performance, for example, the diagnostic sensitivity and specificity required.
From a regulatory perspective alone, usability should be high on the list of priorities when it comes to self-tests and near-patient tests. After all, it is the subject of a lot of IVDR requirements (see above). However, from a purely practical perspective as well, manufacturers should take into account that their device is intended for laypersons and/or use in uncontrollable environments.
A lot of self-tests and POCTs can only be used correctly after instruction. Therefore, safe and effective use is only possible with good instructions for use and, if necessary, after training. This means manufacturers should take special care to ensure the usability of the instructions for use and, if applicable, quick reference guide.
The usability engineering process described in IEC 62366-1 should be followed.
You can find more information in our article on instructions for use.
Contact our usability experts who will help you find usability problems early with a quick formative assessment, so you can avoid rework and problems during the conformity assessment.
Self-tests have a higher potential for foreseeable misuse. Their use in unanticipated situations or locations also makes them high risk.
In the case of POCTs, in contrast, a change of user group is possible in some cases, for example, from nurses to carers for the elderly or pharmacy assistants.
Manufacturers must systematically analyse and manage these risks and document them in the risk management file.
You can find further information in our article on risk management
If the use scenarios of comparable devices overlap significantly, manufacturers should check whether they can group them together in one usability study. But be careful: deciding what can be grouped together and what has to be tested individually is often difficult. So, make sure that the scenarios really are identical and that the corresponding intended purposes do not result in any further risks in the use scenarios. If you have any doubts, you can ask the experts at the Johner Institute.
Example: If a manufacturer offers several different lateral flow tests as allergy tests and they all have the same test principle and test procedure and if the user groups and use environments have the same fundamental characteristics, the use scenario is identical and a generic device group can be evaluated for several devices.
Since it is difficult for manufacturers to predict how and where users will collect and analyse self-test and near-patient test samples, making them easy to handle is essential. The less users have to pay attention to and, therefore, the less they can get wrong, the more reliable the final results will be.
Manufacturers of self-tests and near-patient tests should therefore definitely pay close attention to usability. The accompanying information (particularly the instructions for use) should also be understandable for all intended users, even under stressful conditions. As a result, manufacturers must plan usability studies at an early stage and with the required scope.