As the COVID-19 pandemic has progressed, technology aimed at helping to measure and curb its spread has developed rapidly. Marketing for antibody tests in particular has become more common since a number of them were evaluated by Public Health England earlier this year. Antibody tests indicate whether or not an individual has ever been infected with the virus in the past, by measuring whether they have developed antibodies to it. They are used to gain an understanding of the prevalence of the virus in different places and are distinct from diagnostic tests, which test whether an individual is currently infected with the virus.
It’s understandable that the public are eager for solutions that will help put them on a route back to a more normal everyday life, and protect themselves and their loved ones - especially those most vulnerable. At the same time, the quantity of new and quickly changing information about testing for the virus can make this a confusing area for many. Advertisers need to take care to ensure that they are providing accurate information that does not mislead about their tests’ capabilities and the implications of results for consumers’ lives.
Ensure the test is legally on the market
Antibody tests are classed as in-vitro diagnostic medical devices and must be CE-marked under the relevant regulations.
Antibody tests may involve a blood sample being taken by a health professional at a clinic, or a ‘fingerprick’ sample being taken at home by the user. In all cases, samples should be assessed by a qualified technician in a lab.
For further information about ensuring your test is in line with regulatory requirements, please refer to guidance from the MHRA here.
Be clear about what kind of test it is
As above, antibody tests are different from diagnostic tests, and do not indicate whether someone currently has COVID-19. Advertisers should take care not to imply that results of an antibody test will show if a person is currently infected.
Don’t imply that a positive antibody result means the user is immune
At time of writing, we understand that there is no strong evidence yet to suggest that those who have been proven to have had the virus and to have produced antibodies are immune from the SARS-CoV-2 virus.
Receiving a positive antibody result does not mean that a person is immune, or that they can’t pass on the virus to others. Because COVID-19 is a new disease, understanding of the body’s immune response to it is limited and it is not known how long an antibody response lasts, whether the antibodies produced are effective in neutralising the virus, and whether having antibodies means a person cannot transmit the virus to others. The value of antibody tests is currently limited to answering the question of whether or not someone has had the virus, and providing data and a greater understanding on the spread of the virus.
This means that, based on current scientific understanding, advertisers should avoid stating or implying that users who test positive for antibodies could be immune to the disease and therefore able to go about normal activities with reduced risk of becoming infected or infecting others.
The ASA recently upheld three complaints about ads for antibody tests. Ads for one company stated “We are on a mission to safely get you back to your friends and back to work”, “Get your answers” and referred to “peace of mind” as well as stating “Antibody testing will tell you if you've had the virus and developed an immune response. This is particularly important for asymptomatic people who may unknowingly spread COVID-19 to people they love in high risk groups”.
Another company stated “Getting back to work with COVID testing”, “… you might be thinking about getting back to work or the implications of visiting family and friends” and “This simple blood test can tell you within 2 days whether you have potential antibodies (immunity) to COVID 19”. The ASA considered that these ads gave a misleading impression that the tests could inform users whether they were immune to COVID-19 and enable them to get back to work and seeing friends and loved ones without risking contracting or spreading the disease.
The subject of the third ruling made less overt claims but nonetheless referred to the test showing that users had developed an “immune response”. While technically accurate, the ASA considered that, given the low level of understanding of what antibody tests were for and the lack of further explanation in the ad, the ad was likely to mislead for similar reasons to the others.
Don’t mislead about accuracy
In the same ruling, the ASA considered that consumers would understand the claim “100% accurate results” as an indication that the antibody test would detect, without fail and in all circumstances, whether or not a patient had contracted COVID-19.
When determining the accuracy of a test, both its sensitivity and specificity must be taken into account. In this case, the ASA concluded that neither the sensitivity rate, nor the specificity rate, when used in isolation, were likely to conform to consumers’ likely understanding of ‘100% accuracy’ as presented in the ad. Furthermore, the advertiser had not provided any information to explain the basis of their claim.
This is a highly technical area with which consumers are likely to have little familiarity, and businesses are best advised to provide clear and unambiguous information to explain any claims for ‘accuracy’.
Don’t make misleading endorsement claims
Generally, advertisers must not claim that they or their products have been approved, endorsed or authorised by a public or private body if they have not.
Public Health England has made evaluations of some antibody tests and published those evaluations on its website. However, it does not endorse or accredit tests. Claims that tests are “approved” by Government or any specific public body such as Public Health England are likely to mislead – as the ASA ruled in this case.
For further advice on the advertising of COVID-19 related products and services such as hand sanitisers, face-coverings, medicines and food supplements – and also on issues of creating unjustifiable fear or distress in COVID-19 related advertising - see our AdviceOnline article here. If you’re still unsure about your own non-broadcast ads, the CAP Copy Advice team can offer free bespoke advice.