[Withdrawn] General population COVID-19 testing (domestic asymptomatic): minimum standards for providers
Updated 25 October 2023
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This publication is available at https://www.gov.uk/government/publications/minimum-standards-for-private-sector-providers-of-covid-19-testing/general-population-covid-19-testing-domestic-asymptomatic-minimum-standards-for-providers
Introduction
General population coronavirus (COVID-19) testing is for asymptomatic individuals who want to book and pay for their own test.
This guidance sets out the minimum standards that private providers must meet when offering this testing service to organisations and members of the public.
It includes standards for:
- asymptomatic PCR tests
- asymptomatic lateral flow tests
Self-declaration
Providers must complete a self-declaration form stating that their tests meet all of these standards.
This self-declaration must only be completed by front-end providers who will be directly selling general population COVID-19 tests for asymptomatic individuals.
The providers completing the self-declaration will self-declare on behalf of themselves and all of the organisations they’re working with to provide these tests. They will need to list all organisations that they will be working with (whether by subcontract or otherwise) in order to carry out this service.
If there’s a change to any information submitted in their self-declaration, the provider will need to notify the Department of Health and Social Care (DHSC) of the nature of the new arrangement.
Providers cannot legally sell tests until they meet the standards required.
Start the private sector provider self-declaration process
See the list of successful self-declared private providers of COVID-19 testing
UKAS accreditation and the GOV.UK lists
Providers that have completed their self-declaration and have been successfully assessed against the relevant minimum standards by the United Kingdom Accreditation Service (UKAS) will be published on the GOV.UK list of providers for the testing service they offer.
For more information and guidance:
- visit the UKAS website
- read government guidance on how to become a private provider of COVID-19 testing
Penalties and offences
If a private provider does not meet the standards required, they may be committing an offence and subject to enforcement action and the resultant penalty.
Problems with test kits and results
Where a test kit is broken, is not delivered or gives an inconclusive or invalid test result, the provider should offer a replacement kit as soon as possible to the consumer.
Minimum standards that apply to general population COVID-19 testing (domestic asymptomatic)
The current minimum standards are summarised as follows:
1. Requirement for a medical director and clinical scientist
The provider must have a designated resourced role that has oversight and approval of medical practices undertaken by the provider and responsibility for reporting medical issues. The individual must be a registered medical practitioner – registered with the General Medical Council.
The provider must also have a designated resourced role that has oversight of clinical practices undertaken by the provider and responsibility for reporting clinical issues. This individual must be a registered clinical scientist, registered with the Health and Care Professions Council.
The same individual can fulfil both roles (medical and clinical) providing they are duly registered.
2. The test device must be an approved COVID-19 test device which is permitted to be put into service in accordance with part 4 of the Medical Devices Regulations 2002, other than solely by virtue of regulation 39(2) of those regulations
This requirement is to ensure that the testing device has a CE marking (or, following the UK’s exit from the European Union, a UK marking) and does not benefit from a derogation from those standards. A CE mark is a logo that is placed on an in vitro diagnostic (IVD) medical device to show that it conforms to the requirements of the In Vitro Diagnostic Medical Devices Directive 98/79/EC.
A CE mark shows that the testing device is fit for its intended purpose stated and meets legislative requirements relating to safety. Tests with a CE mark can be used until 30 June 2023.
Alternatively a test with a UKCA mark can be used.
All COVID-19 tests being supplied and put into service by private providers must have been approved under the Coronavirus Test Device Approvals (CTDA) legislation or listed on the protocol. The validation of COVID-19 tests has set a minimum bar for the performance of COVID-19 tests, which will drive up performance standards and give confidence to UK consumers in the accuracy and performance of the tests they procure.
The word ‘approved’ relates to a process by which coronavirus test devices must be approved by the Secretary of State at the time that it is provided/dispatched to the international arrival. This is under regulation 34A of the Medical Devices Regulations, which was inserted into Part 4 by the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.
Further information is available on:
- CE marking
- UKCA marking
- in-vitro diagnostic medical devices
- Coronavirus Test Device Approvals legislation
- Guidance overview: COVID-19 test validation approved products
3. Alignment to DHSC MHRA target product profile scope
The Medicines and Healthcare products Regulatory Agency (MHRA) has published target product profiles (TPPs) for different types of test, setting out the ‘scope’ of what that test should be used for, including target use, target user and target use settings.
The provider must declare that they’re using the test in line with its published scope. MHRA has set out guidance explaining how both virus and antibody tests work.
For further information, see:
- about MHRA
- for patients, the public and professional users: a guide to COVID-19 tests and testing kits
- target product profile: antibody tests to help determine if people have recent infection to SARS-CoV-2
4. Reporting of coronavirus test results
The test provider must have a system in place for reporting positive, negative, inconclusive (indeterminate) and void test results to UKHSA in accordance with public health legislation.
Providers who use a laboratory to process test results are not under a legal requirement to report but should ensure they pass all relevant information to their laboratory to meet statutory requirements for reporting COVID-19 test results to UKHSA. Every effort should be made to provide the testing laboratory with the required case information. If the laboratory does not receive sufficient case information to report to UKHSA directly, the laboratory will need to agree a process with UKHSA to ensure that the provider of the test, or a third-party client, provides the required test and case information to meet the laboratory’s legal reporting obligations.
Point-of-care testing (POCT)
POCT providers using NHS Test and Trace or government-provided kits should report results online.
For those using privately acquired POCT kits, please contact the POCT support team on poct.contact@phe.gov.uk. This data must follow a specific format, and the template is available from the UKHSA POCT support team. Read the full guidance on COVID-19 and influenza point-of-care testing results: how to report.
It is a requirement that POCT providers transfer the following information to UKHSA, insofar as it is known to the test provider.
In relation to the person being tested:
- first name
- surname
- sex
- date of birth
- NHS number (if known)
- ethnicity
- home address (including postcode)
- telephone number (only in the case of SARS-CoV-2 positive or indeterminate results)
- email address (only in the case of SARS-CoV-2 positive or indeterminate results)
In relation to the test:
- name of the test provider
- the type of establishment of the test provider (for example school)
- test result code (such as COVID-19 +ve/-ve or influenza A +ve/-ve)
- specimen identification number (if applicable)
- specimen type
- specimen date
- date the test was performed
- test method (for example PCR)
- name of the testing equipment manufacturer
Positive and indeterminate COVID-19 test results should be reported to UKHSA as soon as they are available from the test device and, at the latest, within 24 hours, which is the statutory requirement.
Negative and void COVID-19 test results, and positive, indeterminate, negative and void influenza test results, can be sent to UKHSA within 7 days of testing.
Laboratories
There is a legal requirement for laboratories to report positive, negative, inconclusive (indeterminate) and void test results cases to UKHSA in accordance with public health legislation.
To support the reporting of the required infectious diseases, UKHSA has developed the Second Generation Surveillance System (SGSS). This is the national surveillance system that holds all test results.
It is understood that laboratories may not have established systems to report results to UKHSA. However, there is a legal requirement to report. It is recommended that laboratories in this situation contact the SGSS helpdesk on sgss.helpdesk@phe.gov.uk or the SGSS COVID Incident Team on sgss.covidincident@phe.gov.uk and they will put the laboratory in touch with the local SGSS support team. Read the full guidance on Notifiable diseases and causative organisms: how to report.
Laboratories are legally required to report the following information to UKHSA, insofar as the laboratory has this information.
In relation to the person being tested:
- first name
- surname
- date of birth
- sex
- home address (including postcode) or alternative address if not home address
- contact telephone number (only in the case of SARS-CoV-2 for positive or indeterminate results)
- contact email address (only in the case of SARS-CoV-2 for positive or indeterminate results)
- ethnicity
- NHS number
In relation to the test:
- sample taken date and time
- date and time sample was received by lab
- details of causative agent
- the result of any antimicrobial susceptibility test and any resistance mechanism identified in respect of the sample
- sample type
- test method (for example PCR)
- result (such as COVID-19 +ve/-ve)
- name of laboratory
- address of laboratory
- name, address and organisation of the person who solicited the test
Laboratories should ensure they receive all relevant information from the provider to ensure accurate reporting.
If laboratories do not have this data, they should request the missing data from the provider who solicited the test, as it helps to break down the transmission of COVID-19.
In addition to the legally required information outlined above, laboratories should also provide the following fields, insofar as the laboratory has this information:
- sample number/specimen ID – the format of the specimen must be as follows: ‘Reporting Laboratory Shortcode’ (the laboratory shortcode is the code provided by UKHSA) – ‘sample ID’ (this should be unique regardless of test method). The specimen ID should be a maximum of 25 characters and you should quote this ID in any communication of the sample (for example ABC-8263792).
- result date
- other – please detail if additional information is available (any other required information should be submitted through this field)
COVID-19 positive test results must be reported within 24 hours of being detected and, if possible, reported multiple times a day. Diagnostic laboratories are required to notify UKHSA of other test results within a maximum of 7 days, but daily reporting is preferred to enable timely public health action.
For further information, see:
5. Relevant systems in place to report adverse test incidents
The provider must be able to demonstrate that it has systems in place to identify any adverse incidents or quality control issues in respect of the test device and be able to report them in a timely manner to the relevant regulatory body. MHRA has a dedicated COVID-19 Yellow Card portal to report adverse incidents with medicines, medical devices and diagnostics.
For further information, see:
6. Samples shall be taken by a provider meeting or working towards ISO standard ISO15189 or ISO/IEC17025
MHRA has published target product profiles (TPPs) for different types of test, which outlines who should collect test samples under the ‘target user’ description.
The provider must have relevant competency-based trained test operators undertaking or overseeing sample collection dependent on test sample collection requirements.
The ISO standard and technical specifications set out the key components that should be considered to provide safe and reliable sample collection service.
Sampling can be accredited as part of a wider lab-based activity, or sampling can be the scope of a standalone, separately accredited legal entity.
For further information, see:
7. Clinical governance
The provider must have clear clinical governance procedures in place. For example:
- clear governance and lines of accountability such as senior responsible officer, clinical lead, quality lead, training lead
- staff are appropriately trained and there is evidence of competency assessment and participation in relevant external quality assessment (EQA)
- liability and indemnity cover for staff
- a verification report for the laboratory element of the test (known as the assay), in line with national protocols for laboratory-based testing
- information management systems to monitor sample delivery and tracking
- systems to meet the provisions for handling, transportation and analysis of test samples
- working to containment level CL3 or CL2+ with Health and Safety Executive (HSE) approval for laboratory-based testing
- systems, processes and record management to support the delivery of safe and reliable service
Where private providers are providing employee testing they should read employer guidance.
8. For PCR lab-based testing: providers shall be or use a UKAS-accredited lab or applicant laboratory to either ISO 15189 (Medical Laboratories – requirements for quality and competence) or ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories)
For polymerase chain reaction (PCR) testing, all samples must be processed by a UKAS accredited laboratory, or UKAS applicant laboratory (the laboratory has applied for UKAS accreditation but has not yet achieved it), and have quality management systems operating according to ISO 15189 and/or ISO/IEC 17025. ISO 15189 is the standard used in all NHS laboratories.
UKAS accreditation provides an assurance of the competence, impartiality and integrity of laboratories. This accreditation is an important element in establishing and maintaining confidence in a testing service.
For further information, see:
9. For point-of-care testing: providers need to meet ISO standards ISO 15189 and ISO 22870 ‘point-of-care testing (POCT) – requirements for quality and competence’
Samples shall be processed by a UKAS accredited or applicant provider.
These ISO standards and technical specifications set out the key components that should be considered to provide safe and reliable POCT service.
It is expected that UKAS accreditation to ISO 15189 and ISO 22870 will become a mandatory minimum standard by summer 2021.
Providers are encouraged to adhere to ISO 22583 “Guidance for supervisors and operators of point-of-care testing (POCT) devices”.
For further information, see:
10. Compliant with all legal and regulatory requirements for sample collection, processing and sharing of results including the requirements of data protection legislation
The legal and regulatory requirements for private testing are set out in the guidance for employers and third-party healthcare providers below. This includes GDPR considerations.
The Information Commissioner’s Office (ICO) has set out FAQs on data collection and data protection relating to COVID-19 that provide further information.
For further information, see: