Regulating coronavirus (COVID-19) antibody testing

Page last updated: 12 May 2022
Organisations we regulate

Antibody tests are blood tests designed to show whether people have had coronavirus (COVID-19) and are now immune.

At the time of writing, antibody tests are still in development and none have been approved in a laboratory setting. Unapproved tests can potentially be misleading by providing inaccurate or inconsistent results. This could put those tested and those around them at risk of contracting coronavirus and transmitting it to others. On 18 April 2020, Professor John Newton, national coordinator of the UK coronavirus testing programme, released a statement advising against the use of unapproved antibody tests in the UK.

CQC encourages all providers to properly consider Professor Newton’s advice. If registered providers do decide to offer this form of testing in spite of the associated risks, they must do so in accordance with regulation 9 (person-centred care) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This requires registered providers to support service users to understand and make informed decisions about their care and treatment options. As such, we would expect you to make it clear to service users that this form of testing has not yet been verified in a laboratory setting and therefore, the efficacy of these tests is not yet proven. We would also encourage you to make service users aware of the above statement in order that they understand the risks involved and are able to make an informed decision prior to giving consent.

The removal of fluids (including blood samples) from a service user and/or the analysis of those fluids (whether undertaken separately or in conjunction with one another) are both activities that fall within scope of the Diagnostic and Screening Procedures (D&SP) regulated activity. If you offer coronavirus antibody testing and are involved with any of the following:

  • removing the sample from the patient and sending that sample on to a laboratory for analysis
  • both removing the sample and using equipment to examine the sample for the purposes of detecting the presence of coronavirus
  • using equipment to examine a sample for the purposes of detecting the presence of coronavirus

you must be registered with CQC for the D&SP activity, unless a specific exception applies.

There are two exceptions to the D&SP activity which are likely to affect the need for many providers carrying out this form of testing to register with CQC for D&SP:

  1. if you are taking a blood sample by means of a pin prick or from a vein and that sample does not need to go to a laboratory for analysis, you will not need to register with CQC in relation to this part of your service
  2. if you are already registered with CQC to undertake any of the other regulated activities, you will not need to additionally register for D&SP if you are involved in either:
    • the taking of blood samples
    • the analysis and reporting of the results of those tests

    In both situations, coronavirus antibody testing would not fall within scope of CQC regulation.