The licensing and regulation of HIV tests

Published: 30 June 2012

  • HIV tests are not approved for use in the same way as HIV drugs.
  • The system is not as rigorous or as transparent.

Whereas new anti-HIV drugs can only be made available to doctors and patients after completing a rigorous process of clinical trials and approval by regulatory agencies, the situation for HIV diagnostic tests is different.

In the United States, while there are differences in the detail, the basic principles of approval of drugs and diagnostic tests are comparable.

However in the UK and Europe, the regulatory environment for diagnostic tests is not as strict or as transparent as it is for drugs. Supporters argue that the system allows companies to make innovations available quickly, while meeting safety standards. An example would be fourth-generation tests, introduced in Europe over a decade before becoming available in the United States. However critics say that products can be brought to market without their performance or safety being demonstrated, and with limited safeguards.

Concerns about the limitations of regulation highlight the value of being tested by a medical professional who has the support of experienced laboratory staff. These professionals are able to select diagnostic equipment that which has proven to be accurate and interpret the results appropriately. Perhaps most importantly, if a test result is unclear or if it may be positive, they are able to re-test samples with alternative, confirmatory tests in order to be sure of the correct diagnosis.

This is not the case for home testing kits sold illegally through the internet. 

Experts, including the British Association for Sexual Health and HIV, note that the CE-mark is not, in itself, a guarantee of quality.1,2,3

The regulatory system

The regulatory system is defined in a series of European Union directives, which have been put into UK law as the Medical Devices Regulations 2002 and are implemented across Europe by different national regulatory agencies. In the UK, this is the Medicines and Healthcare Products Regulatory Agency (MHRA).

However the national agencies do not themselves scrutinise safety and effectiveness data. They accredit and audit private companies called ‘notified bodies’ which make independent judgments about whether a medical device complies with EU directives. Products which are approved by a notified body can display the CE mark, the European safety standard.

In 2011, there were 76 notified bodies in the EU, including six in the UK. One of them is BSI, which also issues the kitemark symbol that is seen on many household and industrial products.

Manufacturers should provide the notified body with a precise definition of the intended use of the device. They should provide evidence that the device meets safety requirements.

They should also demonstrate to the notified body that the device meets certain technical specifications.4 In the case of HIV diagnostic tests, these include:

  • Sensitivity of at least 99.5%, based on testing at least 400 samples that are positive for HIV-1 (including 40 with non-B subtypes) and 100 samples that are positive for HIV-2.
  • Specificity of at least 99.5% (99% for rapid tests), based on testing at least 5000 unselected samples as well as 200 samples from hospital patients and 100 samples from people with medical conditions that could potentially skew test results (pregnancy, rheumatoid arthritis, other viral infections, etc.).
  • The ability to detect recent infection “has to represent the state of the art” but there is no quantified target.

Systems for long-term monitoring of the quality and outcomes with use of products are minimal. However, if reports of problems do emerge, the notified body can order the manufacturer to remove the CE mark.

Manufacturers can choose which notified body to work with, in any European country. Moreover, the manufacturer is the client of the notified body. There are concerns that the system allows manufacturers to pick the notified body which they think will put their device through the least stringent checks.

There is limited information in the public domain about the devices which have been approved. There isn’t a centralised registry of approved devices which provides documents explaining why a device was given the CE mark, gives the data submitted to the notified body or says which notified body was involved. Moreover, companies routinely refuse to provide this information.5

An expert on patient safety has commented that while the system is ‘fit for purpose’ for those who follow all the rules, it is not for companies who “just do the paperwork and move on, hiding under the CE marking”.1

The system means that healthcare providers cannot rely on regulatory oversight and must themselves be vigilant about which diagnostic tests they use. However, the lack of publicly available information does not help them to do so.

Despite this, the vast majority of HIV diagnostic tests which are used in the UK (especially laboratory fourth-generation tests) have been demonstrated in independent research to be extremely accurate. These data are summarised in the ‘Types of test’ section.

Related links

Ban on home testing

In addition to the general EU legislation on medical devices, the UK has a specific law on HIV test kits. HIV testing can only be provided by medical professionals and test equipment cannot be sold to members of the public for home testing.6

References

  1. Horton R Offline: The scandal of device regulation in the UK. The Lancet, 2012
  2. BASHH and MedFASH Standards for the management of sexually transmitted infections. , 2010
  3. Nick S Sensitivities of CE-Marked HIV, HCV, and HBsAg Assays. Journal of Medical Virology, S59-S64, 2007
  4. Commission of the European Communities Commission decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (2002/364/EC). Retrieved January 19, 2012, from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2002:131:0017:0030:en:PDF, 2002
  5. Cohen D & Billingsley M Europeans are left to their own devices. BMJ, 1124-1127, 2011
  6. Department of Health HIV testing kits and service regulations 1992. www.opsi.gov.uk, 1992
This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.
Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.