Can't Wait Q2 - Next News - Launch Antigen LFT5 Jun 2021 19:09
Having a read of these earlier - we certainly seem to tick the government boxes in the below doc - Lateral flow validation prioritisation criteria for rapid diagnostic assays for specific SARS-CoV-2 antigens
Priority will be given in the following order for lateral flow devices where the IFU and CE mark allow for:
self-test: a test that can be performed by any individual at home without receiving prior training – you can find out more about CE marks, UKCA marks and MHRA exemptions from medical device regulations that allow lateral flow devices to be used in self-testing
self-swab and the test is then performed by a trained individual: the IFU allows for a patient to collect their own sample, either supervised or unsupervised - the test procedure can then be performed by an individual who has received training
test performed by a trained individual: the test can be performed by someone who has received training - this person does not have to be a medically trained professional or have experience working in a laboratory setting
tests administered by a healthcare or medical professional
Other characteristics for lateral flow devices
DHSC has identified other desirable characteristics for lateral flow devices that are in addition to the selection criteria that are outlined above.
The desirable characteristics will not inform the prioritisation for validation, but are included to provide suppliers of lateral flow devices with a better understanding of DHSC's likely requirements for predicted future use cases:
the ability to supply lateral flow tests in various pack sizes - for example, pack sizes of 1, 3, 5, 7 and 25 tests
proof that the test was run with actual human sample - for example, the inclusion of a control line specific to human mucosal antigens
each sterile swab has an individual containment tube with recappable lid, providing the ability to store the swab for quality review
the ability to provide a response in 15 minutes or less
an individual QR code on the test cassette - this is essential
https://www.gov.uk/guidance/lateral-flow-validation-prioritisation-criteria-for-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens
https://www.gov.uk/government/publications/assessment-and-procurement-of-coronavirus-covid-19-tests/protocol-for-evaluation-of-rapid-diagnostic-assays-for-specific-sars-cov-2-antigens-lateral-flow-devices
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