Guidance

For testing service providers: COVID-19 tests and testing kits

Updated 8 August 2023

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This publication is available at https://www.gov.uk/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-testing-service-providers-covid-19-tests-and-testing-kits

There is a growing demand for COVID-19 testing outside of a hospital laboratory environment, within both public and private sectors. This includes non-healthcare settings (e.g. schools, workplaces, universities, airports, weddings, sports events, religious events) and use by people who are not healthcare professionals with minimal training. These services needs to be fit for purpose and meet national guidelines.

1. Who this guidance is for

This guidance is for commercial testing service providers. Testing services may include a number of processes such as:

  • identifying people to be tested
  • taking samples and labelling the sample and request form with the correct patient information
  • sending samples to a laboratory for processing and/or processing samples locally (point of care or near patient testing)
  • understanding and interpreting the results
  • communicating results to the person being tested
  • running internal quality control checks and follow correct standard laboratory operating procedures as per ISO 15189 guidelines (if done locally)

Testing service providers may choose to contract out one, several or all of these processes to a third party. For example, workplace testing may involve occupational health providers, GP services and a laboratory. The contracts in place between the different parties will establish who is ultimately responsible for the testing service.

2. Existing guidance

There are already a number of existing guidance pieces that should be followed.

The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 set out the requirements for certain tests for COVID-19 to meet specified standards.

Testing service providers should also follow the minimum standards set out in relevant guidance published by the Department of Health and Social Care:

UKAS has been working with the Department for Health and Social Care to develop a three stage UKAS accreditation process for private providers of COVID-19 testing.

3. MHRA guidance

In addition to the guidance above, we have drafted guidance to help testing service providers offer a quality service that follows good clinical governance.

3.1 Obligations on testing service providers

Testing service providers must be clear with customers on:

  • the benefits and limitations of being tested
  • how reliable the results will be, including limitations
  • what a test result means, in non-medical language
  • how they are following the measures set out in current guidance

3.2 Sample collection kit requirements

The individual components (for example specimen collection tube, nasal swab or lancet) should meet the relevant regulatory requirements and should be used for their original intended purpose.

The complete kit (all the components together with packaging, labelling and instructions) should also meet the regulatory requirements as set out in UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended). To support the CE, CE UKNI or UKCA marking of the kit, manufacturers should hold data on usability for the intended user (especially true for kits intended for home use), transport stability, analyte stability, test limitations and traceability of components.

3.3 Test requirements

Before offering the test, service providers should confirm that:

  • the sample type being used in the test is covered by the CE, CE UKNI or UKCA mark – this information should be stated in the manufacturer’s instructions for use.
  • the test has been validated by the manufacturer for use with the sample collection kit. This information should be stated in the manufacturer’s instructions for use (IFU) of the product. This is in accordance with the Medical Device Alert issued by the MHRA regarding testing services.

3.4 Laboratory validation

Testing service providers should confirm that the laboratory being used is UKAS accredited. This means the laboratory has a Quality Management System (QMS) to ISO 15189 and/or ISO 17025. This is the standard expected of all NHS laboratories. It is advisable to check the laboratory’s UKAS accreditation includes COVID-19 testing.

In addition to UKAS accreditation, laboratories should only use CE, CE UKNI or UKCA marked test kits for their intended purpose. They should also verify their performance before use and report problems to MHRA via the Coronavirus Yellow Card portal.

Laboratories are legally obliged to ensure they have a mechanism to report any positive COVID-19 cases to Public Health England as a notifiable disease.

Further guidance and standards regarding validation and verification can be found below:

DHSC also publish lists of and information about approved suppliers in the UK of private testing kits for coronavirus (COVID-19).

4. Point of Care Testing

For COVID-19 testing service providers in point-of-care setting, please see our guidance on in-vitro point-of-care testing.

ISO 22870 describes the requirements for quality and competence applicable to point of care testing and is to be used in conjunction with ISO 15189.

Point-of-care testing (POCT) equipment must be used in accordance with the manufacturer’s CE, CE UKNI or UKCA marking and Instructions for Use, with appropriate assessment of its operation in line with internal quality control performance and manufacturer’s maintenance schedules. POCT providers must ensure that the POCT analyser/instrumentation has been adequately tested and validated for use within their context of operation and patient populations.

5. Further information

The UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) give more information on the definitions and regulations of medical devices, including: a medical device; an in vitro diagnostic medical device (see appendix); and manufacturer and supplier.

If a testing service takes on the role of legal manufacturer, then the regulations that cover manufacturing become obligations. MHRA has also issued guidance for manufacturers.

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