A direct email from the London Vaccination Clinic, received 27 May 2020, featured the subject line “Getting back to work with COVID testing and current services”. The main body of the email included the claims “Getting back to work or out and about with COVID testing and the London Vaccination Clinic”, “… 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” and detailed different antibody tests for COVID-19. One was called “ANTIBODY TEST””, and included the claims “Detects IgG antibodies (long-term immunity [sic]”, and “Lab analysis using Abbotts Architect analyser”. Another was called “IN-CLINIC RAPID ANTIBODY TEST” and included the claims “German made, Nadal antibody test, CE approved”, “Detects IgM and IgG antibodies”, and “(Recent infection and longer term immunity respectively)”.
IssueThe complainant challenged whether the claims that the tests could indicate that users had immunity to COVID-19 were misleading.
360 Health Ltd said that corporate customers contacted them to request testing for their workforce, to enable their staff to get back to work. They reported that their staff would feel reassured if they knew whether or not they had had the infection. They said that some of their clients worked with the NHS and they felt it was important to know if they had been infected before continuing with work or seeing their families. They said that the Abbotts serology test detected IgG antibodies, which related to longer-term immunity or gM antibodies, which indicated a more recent infection. They said that antibodies were produced approximately 14 days after the initial infection and involved memory B plasma cells. They said that they did not know to what extent IgG protected the body from COVID-19 in the long term. They said that the difference between IgM and IgG was explained to their clients.360 Health stated that information on their website and at their clinics explained that there was not enough research or data available to understand the development of immunity to COVID-19. They said that they ensured that their clients understood the importance of following Government guidelines.
360 Health said that they had received five star reviews on a review website and provided a screenshot of a customer review. They said that they did not believe that the majority of people found their ad to be misleading and they had not received any other complaints. They said that they would review the messages across their websites and social media to ensure that the information provided was compliant. 360 Health provided the manufacturer’s instruction sheets for the testing kit’s intended use, as well as an Evaluation Report by Public Health England of the testing kit.
The ASA understood that both the antibody tests listed in the email were CE-marked in vitro diagnostic medical devices intended for the detection of antibodies to SARS-CoV-2. Both tests involved samples being taken in a clinic by a trained medical professional. CE certification in itself did not constitute evidence for medical efficacy claims, and advertisers needed to ensure that they held evidence for such claims. We considered the claims in the ad, which included “Getting back to work with COVID testing and current services”, “… 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”, as well as references to different types of antibodies, “long-term immunity”, and “Recent infection and longer term immunity respectively.” We noted that the qualification “potential” was used in reference to immunity, but we did not consider that conditional language counteracted the impression of efficacy in this context. Further, “long-term immunity” implied that the test would enable people to get back to normal life, rather than just detecting COVID-19 antibodies. We considered that consumers were therefore likely to understand from the ad that a positive antibody test would show that they were immune to COVID-19, and would enable them to get back to work and other normal activities without the risk of contracting the virus again or transmitting it to others.
As of 13 July 2020, Guidance published by the Department of Health and Social Care stated that there was no strong evidence yet to suggest that those who had been proven to have had the virus and to have produced antibodies were immune. Further, it stated that receiving a positive antibody result did not mean that a person was immune, or that they couldn’t pass on the virus to others. It also did not mean that social distancing measures could be ignored.
The Guidance explained that because COVID-19 was a new disease, understanding of the body’s immune response to it was limited and it was not known how long an antibody response lasted, whether the antibodies produced were effective in neutralising the virus, or whether having antibodies meant a person could not transmit the virus to others. It stated that the value of antibody tests was 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. We understood that the Public Health England Evaluation Report of the testing kit provided by 360 Health assessed the test’s accuracy in detecting antibodies.
It did not constitute evidence that the presence of antibodies indicated immunity, which was the message that consumers were likely to take from the ads We noted that there was no information in the ad itself which explained that a positive antibody result did not mean that a person was immune. Taking into account Government advice on the link between antibody testing and immunity, we concluded that the impression given by the ad,that the tests would indicate whether or not consumers were immune to COVID-19, was misleading and breached the Code.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
Marketing communications must not mislead the consumer by omitting material information. They must not mislead by hiding material information or presenting it in an unclear, unintelligible, ambiguous or untimely manner.
Material information is information that the consumer needs to make informed decisions in relation to a product. Whether the omission or presentation of material information is likely to mislead the consumer depends on the context, the medium and, if the medium of the marketing communication is constrained by time or space, the measures that the marketer takes to make that information available to the consumer by other means. (Misleading Advertising), 3.9 3.9 Marketing communications must state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify. (Qualification) and 12.1 12.1 Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, Medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told 360 Health Ltd to ensure that they did not state or imply that a positive antibody test would show that consumers were immune to COVID-19.