Lateral flow evaluation prioritisation criteria for rapid diagnostic assays for specific SARS-CoV-2 antigens
An overview of the future requirements for rapid COVID-19 diagnostic assays for antigen lateral flow devices.
Overview
The UK Health Security Agency (UKHSA) has concluded a review of the most likely future requirements and use cases for rapid diagnostic assays for specific SARS-CoV-2 antigens (lateral flow devices).
The review has enabled the development of selection criteria. The selection criteria will be applied to decide which lateral flow devices should proceed through the evaluation process. The selection criteria are split into primary criteria and secondary criteria. A lateral flow device must conform to all the primary criteria and at least one of the secondary criteria to be considered for evaluation.
The rationale for this approach is that UKHSA will only seek to evaluate lateral flow devices that have predicted future use cases and that the resources available for evaluation will be best deployed to align with the national strategy for testing for SARS-CoV-2.
This page sets out the primary and secondary selection criteria for lateral flow devices. The evaluation will continue to follow the government protocol.
Primary selection criteria
UKHSA will only evaluate lateral flow devices that conform to all the primary selection criteria. The primary selection criteria are as follows:
1. UKHSA will not evaluate lateral flow devices that only allow for a nasopharyngeal or oropharyngeal specimen collection method or both. The lateral flow device must use one of the following specimen collection methods:
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anterior nares swab (either with or without a throat option)
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mid turbinate swab (either with or without a throat option)
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saliva
Lateral flow devices submitted with a specimen collection method higher up on the list will be prioritised for evaluation (for example, lateral flow devices that use an anterior nares swab will be prioritised for evaluation over lateral flow devices that use a mid turbinate swab or saliva). A lateral flow device will only be considered for evaluation when all lateral flow devices with a higher priority specimen collection method have been considered for evaluation.
2. The instructions for use (IFU) or other packaging should allow for both asymptomatic testing and symptomatic testing. The manufacturer must be able to substantiate their claim for asymptomatic testing with clinical performance data.
3. The IFU or other packaging should not restrict the administration of the lateral flow device to medical personnel or healthcare professionals only. The manufacturer must be able to substantiate their claim with clinical performance data.
4. The lateral flow device must be specific for nucleocapsid antigens.
5. The manufacturer must be able to provide multiple pack sizes, as required by UKHSA, with flexibility to adapt to UKHSA customisation requirements for packaging and IFU design.
6. The manufacturer agrees to an ongoing programme of assessment of their lateral flow device against new variants of concern and understands that UKHSA contracts will have prescribed obligations regarding the in-silico analysis of their test’s performance with respect to common mutations (including variants of concern).
7. The manufacturer must demonstrate the capability, or a clear path to obtain the capability, to print an individual QR code and unique identifying number onto each cassette.
8. The lateral flow device must be CE marked or UKCA marked for ‘self test’, that is, the lateral flow device can be performed by any individual at home without receiving prior training. You can find out more about CE marks and UKCA marks.
9. All components used with a lateral flow device must not contain:
- substances of very high concern (SVHC)
- any UK or EU REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) reportable materials and substances – in particular, plastic components must not contain restricted phthalates and the buffer solution must not contain 4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated, also called Triton X-100
- any materials on the Restriction of Hazardous Substances (RoHS) Directive list or any materials of animal origin
- natural rubber latex – other sources of latex (such as gloves) must also not be used in any manufacturing areas used to produce lateral flow device components.
Secondary selection criteria
To be considered for evaluation, a lateral flow device must conform to at least one of the secondary selection criteria. The secondary selection criteria are as follows:
1. The lateral flow device is designed with the lay user in mind. The lateral flow device is in a format with multiple features clearly designed to simplify use and reduce the risk of user error.
2. The time required for a ‘T-line’ to be fully developed is less than 7 minutes.
3. The lateral flow device offers quantifiable benefits with regards performance or confirmation of test validity, equality and inclusion (E&I) or other. One of the following are needed to meet this criterion:
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the lateral flow device is ‘ultra sensitive’. In other words the lateral flow device shows a one-log improvement in sensitivity over current lateral flow devices (currently 1 x102PFU/ml). Manufacturers will be required to provide details of the novel or innovative technologies that increase the sensitivity above current lateral flow devices. To be accepted for evaluation the claimed sensitivity must be supported by detailed scientific evidence that has been subjected to peer review
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the lateral flow device has a feature that demonstrates it has been run on a human sample, for example a human antigen specific ‘C-line’
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the lateral flow device provides specific and tangible design features that would improve ease of use for groups with recognised challenges using lateral flow devices
4. The lateral flow device offers the potential to significantly reduce the use of single use plastics and plastics destined to landfill. One or more of the following are needed to meet this criterion:
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the bulk of the lateral flow device is biodegradable and will not generate micro-plastics
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the lateral flow device has a clear and credible route to recyclability
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the lateral flow device is manufactured from non-petrochemical derived materials for example bio plastics and cellulose
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the lateral flow device is manufactured from post-consumer or industrial recycled material
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the test is designed to significantly reduce the quantity of materials required to perform the test
5. The lateral flow device makes an ongoing contribution to the development and sustainability of the domestic diagnostics industry in the UK or supports a resilient pipeline of lateral flow devices in the UK. To meet this criterion, the manufacturer or developer must conform to all the following:
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a company registered in the UK that has all applicable professional licenses and insurances
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the intellectual property rights are wholly owned by a UK-based company with no material risk to intellectual property rights access and use due to actions by a non-UK company or state actor
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the key primary and secondary manufacturing processes are completed in UK (for example, up to and including ready to cassette test strips)
UKHSA recognises that it is not possible to predict every possible innovation. If a manufacturer has developed a test with an unforeseen advantage, we reserve the right to review and permit submission for evaluation if the scientific consensus supports the claim.
Updates to this page
Last updated 2 December 2022 + show all updates
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Updated primary selection criteria.
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Updated primary selection criteria.
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Updated selection criteria for validation of lateral flow devices to reduce the number of lateral flow devices for validation and to better align validation criteria with the strategic direction of the mass testing programme. The intention is to validate more sustainable and easier-to-use lateral flow devices that have improved sensitivity.
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Updates to the self-testing section with links to more detail on the CE mark, UKCA mark and MHRA exemptions from medical devices regulations.
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Update on sample types required for validation of lateral flow devices.
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First published.