# How tests and testing kits for coronavirus (COVID-19) work

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/fba1b70e-f496-4663-88f3-04993e94d661
Type: Guidance
Published: May 12, 2020
Updated: August 8, 2023

> This guidance issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) outlines the regulatory landscape for COVID-19 testing kits and medical devices within Great Britain. The document serves as a central resource for the public, healthcare professionals, and industry stakeholders to understand the operational mechanics and legal requirements of diagnostic tools. Although no specific company name or inspection dates are cited—as this is a general policy document rather than an enforcement letter—the framework focuses on compliance with In Vitro Diagnostic Medical Devices legislation and Great Britain's specific medical device regulations. Key sections detail the various types of COVID-19 tests, such as molecular and antigen assays, and the rigorous technical specifications manufacturers must achieve to ensure safety and accuracy. A significant portion of the guidance addresses the 'in-house' manufacture of medical devices, specifying that health institutions producing their own diagnostic tools must still adhere to high standards of quality management. Required actions for manufacturers include obtaining the necessary UK marking, providing clear instructions for use, and following strict post-market surveillance protocols. By consolidating these standards, the MHRA ensures that all testing kits available on the market meet the statutory requirements for clinical performance and user safety, maintaining public trust in the national diagnostic infrastructure.

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## Content

Information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits, including how they work, the different types of tests and the specifications manufacturers need to follow. Further information on how medical devices are regulated: In-house manufacture of medical devices in Great Britain In vitro diagnostic medical devices: guidance on legislation

## Attachments

- [Target Product Profile: enzyme Immunoassay (EIA) Antibody tests to help determine if people have antibodies to SARS-CoV-2](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-enzyme-immunoassay-eia-antibody-tests-to-help-determine-if-people-have-antibodies-to-sars-cov-2)
- [Target Product Profile: Rapid Breath Tests for the direct and indirect detection of SARS-CoV-2](https://assets.publishing.service.gov.uk/media/603f8787e90e077dce4d388a/Breath_TPP_Final_version_v1.0.pdf)
- [Target Product Profile: Laboratory-Based SARS-CoV-2 Viral Detection tests ](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-laboratory-based-sars-cov-2-viral-detection-tests)
- [Target Product Profile: In Vitro Diagnostic (IVD) self-tests for the detection of SARS-CoV-2 in people without symptoms](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-in-vitro-diagnostic-ivd-self-tests-for-the-detection-of-sars-cov-2-in-people-without-symptoms)
- [Target Product Profile: Point of Care SARS-CoV-2 detection tests ](https://assets.publishing.service.gov.uk/media/5ef5b76686650c1295cb5ec9/TPP_Point_of_Care_SARS-CoV-2_Detection_Tests.pdf)
- [Target Product Profile: antibody tests to help determine if people have recent infection to SARS-CoV-2: Version 2](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-antibody-tests-to-help-determine-if-people-have-recent-infection-to-sars-cov-2-version-2)
- [Target Product Profile: antibody tests to help determine if people have recent infection to SARS-CoV-2: Version 2 ](https://assets.publishing.service.gov.uk/media/5eb40a5ce90e07083a7f74a0/Target_Product_Profile_antibody_tests_to_help_determine_if_people_have_immunity_to_SARS-CoV-2_Version_2.pdf)
- [Target Product Profile: enzyme immunoassay (EIA) antibody tests to help determine if people have antibodies to  SARS-CoV-2](https://assets.publishing.service.gov.uk/media/5edaa86e86650c4ab64fb35e/PW_TPP_Pillar_3_tests_EIA_final.pdf)
- [Target Product Profile: Laboratory-Based SARS-CoV-2 Viral Detection tests ](https://assets.publishing.service.gov.uk/media/618bdd3dd3bf7f0558fdc090/Laboratory-Based_SARS-CoV-2_Viral_Detection_Tests_Version_2.pdf)
- [National technical validation process for manufacturers of SARS-CoV-2 (COVID-19) tests](https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/coronavirus-covid-19-serology-and-viral-detection-testing-uk-procurement-overview)
- [Target Product Profile: In Vitro Diagnostic (IVD) self-tests for the detection of SARS-CoV-2 in people without symptoms](https://assets.publishing.service.gov.uk/media/60cb80ded3bf7f4bd5345434/Self-Test_Virus_Version_1_0_19June2021.pdf)
- [Guidance for manufacturers: diagnostic assurance with SARS-CoV-2 variants in circulation](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/guidance-for-manufacturers-diagnostic-assurance-with-sars-cov-2-variants-in-circulation)
- [Antigen assay guidance for SARS-CoV-2 variant analysis](https://assets.publishing.service.gov.uk/media/64d1fe027a5708000d144883/Antigen_assay_guidance_for_SARS-CoV-2_variant_analysis.pdf)
- [MHRA Communication on antigen assay assurance for SARS-CoV-2](https://assets.publishing.service.gov.uk/media/64d1fe027a57080013144894/MHRA_Communication_on_antigen_assay_assurance_for_SARS-CoV-2.pdf)
- [MHRA Communication on molecular assay assurance for SARS-CoV-2](https://assets.publishing.service.gov.uk/media/64d1fe02a4045e000da84bb0/MHRA_Communication_on_molecular_assay_assurance_for_SARS-CoV-2.pdf)
- [For patients, the public and professional users: a guide to COVID-19 tests and testing kits](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-patients-the-public-and-professional-users-a-guide-to-covid-19-tests-and-testing-kits)
- [For testing service providers: COVID-19 tests and testing kits ](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/for-testing-service-providers-covid-19-tests-and-testing-kits)
- [Target Product Profile: Point of Care SARS-CoV-2 detection tests](/government/publications/how-tests-and-testing-kits-for-coronavirus-covid-19-work/target-product-profile-point-of-care-sars-cov-2-detection-tests)
- [Molecular assay guidance for SARS-CoV-2 variant analysis](https://assets.publishing.service.gov.uk/media/64d1fe027a57080013144895/Molecular_assay_guidance_for_SARS-CoV-2_variant_analysis.pdf)
- [Antigen assay proforma for SARS-CoV-2](https://assets.publishing.service.gov.uk/media/64d1fed0a4045e0011a84bbb/Antigen_assay_proforma_for_SARS-CoV-2.xlsx)
- [Molecular assay proforma for SARS-CoV-2](https://assets.publishing.service.gov.uk/media/64d1fed07a57080013144897/Molecular_assay_proforma_for_SARS-CoV-2.xlsx)