Background

Ad description

A website for Solihull Health Check Clinic, www.solihullhealthcheckclinic.co.uk, seen 2 July 2020, included a web page with the heading “COVID-19 Coronavirus Antibody Blood Testing”. The ad featured text which stated “As a specialist disease treatment clinic, we are now offering COVID-19 Coronavirus Antibody Blood Tests with 100% accurate results within 24 hours of testing. Our coronavirus tests are carried out by a trained medical practitioner in our Solihull based medical clinic and our test indicates if your body has developed an immune response (antibodies) specifically to the SARS-CoV-2 virus or better known as COVID-19 Coronavirus”.

Text underneath stated “Public Health England and Government Approved”.

Issue

1. The complainant challenged whether the claim “100% accurate results” was misleading and could be substantiated;

2. The complainant also challenged whether the claim “Public Health England and Government Approved” was misleading, because it implied the test had received official endorsement; and

3. The ASA challenged whether the ad was misleading because it implied that a positive test result would indicate immunity from COVID-19.

Response

1. Solihull Health Check Clinic said that they only used the Abbott venous sample SST test. They said that Abbott’s test has been found to demonstrate 100% sensitivity and 97.5% specificity, which meant that individuals could have confidence that they have been accurately tested. They provided assessments of the accuracy of the test from the clinical laboratory they worked with and from Public Health England.

2. Solihull Health Check Clinic said they did not claim to be endorsed by anyone, but that they merely highlighted that the test was approved by Public Health England. They said they had been approved by a clinical pathology laboratory to work with them to provide the tests and that all of the test results were provided to Public Health England for inclusion into official testing statistics.

3. Solihull Health Check Clinic said that a positive result indicated that the body had made antibodies and that it had therefore had an immune response to COVID-19. They referred to information from the Isle of Man Government which stated that if an antibody was found, it indicated that that person may have had COVID-19 in the recent past and have developed an immune response against the virus. The guidance said it was unknown how much protection, if any, antibodies might provide against another COVID-19 infection, that having a positive antibody test did not result in immunity to COVID-19 and that the test result would not enable someone to make decisions about work or travel.

Assessment

1. Upheld

The ASA noted that the antibody test offered by Solihull Health Check Clinic was a CE-marked in vitro diagnostic medical device. The test 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 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. We understood that the accuracy of clinical tests could be evaluated in terms of their sensitivity and specificity. Sensitivity referred to the ability of a test to correctly identify patients with a disease, whereas specificity referred to the ability to correctly identify patients without a disease.

We considered both aspects were important to determine the extent to which the antibody test in question was “accurate”. We noted that these terms were not referred to or explained in the ad. We considered that neither the sensitivity rate, nor the specificity rate, when used in isolation, were likely to conform with consumers’ likely understanding of “100% accuracy” as presented in the ad. The report from the advertiser’s laboratory and the evaluation by Public Health England both reported a specificity of 100%. The Public Health England evaluation also cited the manufacturer’s reported specificity of 99.6%. The report from the laboratory stated that the test had a sensitivity of 97.5%. Public Health England’s evaluation showed that for all samples they tested, the test had a sensitivity of 92.7%. The evaluation also indicated that the test’s sensitivity was dependent on the time that had elapsed between being tested and when the patient had reported the onset of COVID-19 symptoms.

Public Health England’s analysis indicated that the sensitivity of the test was 93.9% for samples collected 14 or more days post symptom onset and 93.5% for samples collected 21 or more days post symptom onset. The evaluation also cited the manufacturer’s reported sensitivity of 86.3% for samples less than 14 days post symptom onset but 100% for samples of 14 or more days. We noted that no information on variation of accuracy depending on when the sample was taken was presented in the ad. While the sensitivity results presented by different sources varied, they indicated that a negative test result did not rule out the possibility of a previous infection with COVID-19.

We considered the evidence was not adequate to substantiate that the antibody test would detect, without fail and in all circumstances, whether or not a patient had contracted COVID-19. We therefore concluded that the ad was misleading.

On that point, the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.    3.3 3.3 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),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation) 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).

2. Upheld

We considered consumers would understand the claim “Public Health England and Government Approved” to be an indication that their antibody test had been assessed by Public Health England and by relevant Government bodies, and that it had been endorsed based on its testing effectiveness. We acknowledged that Public Health England had evaluated the test in question for detecting the presence of antibodies against COVID-19, alongside other similar commercial products. However, we understood that Public Health England did not endorse or accredit diagnostic tests. Because we had not seen evidence that the Abbott antibody test had received endorsement from either Public Health England or any other Government body, we concluded that the ad was misleading.

On that point, the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.  (Misleading advertising),  3.7 3.7 Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.  (Substantiation),  3.45 3.45 Marketers must hold documentary evidence that a testimonial or endorsement used in a marketing communication is genuine, unless it is obviously fictitious, and hold contact details for the person who, or organisation that, gives it.  and  3.47 3.47 Claims that are likely to be interpreted as factual and appear in a testimonial must not mislead or be likely to mislead the consumer.  (Endorsements and testimonials).

3. Upheld

We considered the reason consumers would seek out the test was in order to confirm whether or not they had already contracted COVID-19. We considered that the ad’s references to “immune response” in the claim “our test indicates if your body has developed an immune response (antibodies) specifically to the SARS-CoV-2 virus or better known as COVID-19 Coronavirus”, would be understood as an indication that the test would not only indicate whether someone had previously had COVID-19, but also whether they had developed an immunity to it. 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. We acknowledged that the claim “our test indicates if your body has developed an immune response (antibodies) specifically to the SARS-CoV-2 virus or better known as COVID-19 Coronavirus” was technically accurate and that the antibodies tested for were a form of immune response. However, we took into account the wider context of the ad and public discussions around the importance of developing an antibody test which could indicate immunity.

A test which could indicate immunity to COVID-19 would have significant implications for the return to life before the pandemic and we therefore considered that advertisers should be very clear about the service they offered. 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.

We therefore concluded that the impression given by the ad, that the tests would indicate whether consumers were immune to COVID-19, was misleading and breached the Code. On that point, the ad breached CAP Code (Edition 12) rules  3.1 3.1 Marketing communications must not materially mislead or be likely to do so.    3.3 3.3 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).

Action

The ad must not appear again in the same form. We told Solihull Health Check Clinic to ensure that they did not state or imply that their COVID-19 antibody test would always detect whether or not a patient had contracted COVID-19, including by stating that it had “100% accurate results”. We told them not to state or imply that their test had received endorsement from Public Health England or any other Government body, if that was not the case. We told them not to state or imply that a positive antibody test would indicate immunity to COVID-19 where that was not the case. We also told them when advertising their existing antibody test, to include information which clearly stated that it did not indicate immunity to COVID-19.

CAP Code (Edition 12)

3.1     3.3     3.7     3.45     3.47     12.1     3.9    

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