London School of Hygiene & Tropical Medicine

Few UK online sexually transmitted infection test services meet national recommended standards, with independent sector providers the least likely to be compliant, finds a new study published in BMJ Sexually Transmitted Infections.

The findings of this study, carried out by the London School of Hygiene & Tropical Medicine (LSHTM), UK Health Security Agency (UKHSA) and University of Bristol, have concerning implications for patient care and public health, warn the researchers, who call for urgent regulatory change to ensure full compliance.

Online tests are either self-sampling, where the user orders a kit and takes a specimen themselves before posting it for laboratory analysis, or self-testing, where the user takes a specimen and interprets the test result themselves.

Online testing for sexually transmitted infections (STIs) is subject to limited regulatory oversight. But the British Association for Sexual Health and HIV (BASHH) and the Faculty of Sexual and Reproductive Healthcare (FSRH) have issued comprehensive national standards and guidelines covering all aspects of these services.

The researchers wanted to find out how well online UK STI test services comply with these standards and guidelines.

They searched Google and Amazon in June 2020 to find online providers, and found 13 offered self-test kits, 18 offered self-sample kits. They also found two laboratories servicing several providers.

All 13 self-test providers and 13 of the 18 self-sampling providers were privately run. All but one of the self-sample providers were from the UK.

The researchers analysed the information on the tests and associated services on each of the websites. And they requested further details from each provider in July 2020 and again in April 2021 on intended users, the pretest process, the test process (test and specimen type), health information, monitoring and treatment after diagnosis, and accreditation.

This information was then compared with the BASHH and FSRH guidelines and standards.

Just seven providers completed the questionnaire. These responses, together with the website information from all the providers, showed that few of them complied with the national guidelines and standards.

Dr Emma Harding-Esch, Associate Professor at LSHTM and study lead, said: “Online STI testing services are being used more and more, especially during the pandemic when face-to-face contact was limited. However, these tests must be held to the same standard as in-person testing, with correct infections tested for using the correct samples, alongside duty of care such as access to health promotion information, taking of sexual history and post-diagnosis advice.

Currently, the online providers of these tests are not complying with national guidelines and standards. If we do not act now, patients will continue to receive suboptimal care with potentially significant adverse personal, clinical and public health implications. Appropriate regulation is crucial for sustained improvement in patient care.”

The commercial self-sample providers, who advertised to those with symptoms, didn’t differentiate by symptom severity. And eight (seven private, one NHS-commissioned) didn’t offer any advice on accessing preventive treatment after exposure to HIV, as recommended.

Self-test providers didn’t appear to provide any form of triage, and 5 offered tests that were intended for professional use only.

The range of eligible organisms for testing varied, although all self-sample providers offered tests for chlamydia and gonorrhoea. Two even claimed to test for organisms not included in routine NHS testing, even though these organisms aren’t considered STIs.

There was often no health promotion information given, and little in the way of sexual history taking. Inappropriate infections were tested for; incorrect specimen types were used; and there was little advice on what to do after a diagnosis.

Eleven self-test providers had at least one of their tests CE-marked—meaning that the product conforms to European health, safety, and environmental protection standards. Two claimed WHO approval and one claimed US Food and Drug Administration accreditation. 

One self-test provider marked their chlamydia and gonorrhoea tests with an NHS logo, describing themselves as an NHS provider, but it wasn’t clear if these products had been endorsed by the NHS. 

And while UK Accreditation Service (UKAS) accreditation was claimed for self-sample kits, there were no details of the specific laboratory service that had been accredited.

The researchers acknowledge the limitations of this study, including that the providers analysed may have updated their website information since the search was carried out and that those they assessed may not represent the full range of online test service provision in the UK. Additionally, as the study was unfunded, the team were not able to purchase any tests to identify whether information was available post-purchase.

However, the study found very few online providers met the national STI management standards assessed, and there is concern that this will also be the case for service provision aspects that were not covered by this study.

Online testing offers a convenient and flexible option for users. However, the proliferation of providers that do not follow guidelines, in particular for-profit sites, jeopardises these advantages and puts users at risk. 

The team believe if current trends continue, online testing usage will increase, resulting in more online providers as demand rises. They call for regulatory change to ensure that the standard of care received online meets national guidelines to protect patients and the wider population from the repercussions of underperforming or inappropriate tests.

Publication

Eleanor Clarke et al. Assessment of online self-testing and self-sampling service providers for sexually transmitted infections against national standards in the UK in 2020. Sexually Transmitted Infections. DOI: 10.1136/sextrans-2021-055318