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UK Government Updates Selection Criteria for Validation of SARS-CoV-2 Rapid Tests

NEW YORK ─ The UK government on Thursday updated selection criteria to reduce the number of SARS-CoV-2 lateral flow devices reviewed for validation.

The rationale for the update to criteria originally released in February is that it "will only seek to validate lateral flow devices that have predicted future use cases, and that the resources available for validation will be best deployed to align with the national strategy for [the] Test and Trace program," the UK Department of Health and Social Care said.

The update better aligns its validation criteria with the strategic direction of the region's mass testing program, and the overall aim is "to validate more sustainable and easier-to-use lateral flow devices with improved sensitivity," DHSC said.

Following a review of the most likely future requirements and use cases for rapid SARS-CoV-2 antigen assays, DHSC developed primary and secondary selection criteria to decide which lateral flow devices should proceed through the validation process. Lateral flow devices that conform to all the primary selection criteria and at least one of the secondary selection criteria will be subject to validation.

Among the primary selection criteria, lateral flow devices that only allow for a nasopharyngeal or oropharyngeal specimen collection method, or both, will not be validated.

Further, the lateral flow test must use anterior nares swab, either with or without a throat option; or mid-turbinate swabs, with or without a throat option; or saliva. The instructions for use or other packaging should allow for both asymptomatic testing and symptomatic testing, and the lateral flow device must be specific for nucleocapsid antigens, DHSC said, adding that the manufacturer must also agree to an ongoing program of assessment of their lateral flow device against new variants of concern.

Among the secondary selection criteria, the lateral flow device must be CE marked or have UKCA, for UK Conformity Assessed, marking for self-testing, and any individual will need to be able to run the test at home without receiving prior training.