Two LFTs being developed18 May 2020 13:19
Daddypig, thanks for sharing the Avacta blog update. Some really interesting snippets in there. It is almost as if they have been reading this BB to answer our questions.
Sounds like two LFTs are being developed by Cytiva using the Affimers:
‘POC, or Near Patient Testing (NPT), offers a critical solution in cases of pandemics, for effective mass-monitoring and disease management by enabling rapid detection of the virus away from other susceptible individuals, unlike many diagnostic tests that depend on access to specialised laboratory equipment often found in an hospital environment. Whilst POC testing requires use by a healthcare professional it can still be carried out at bedside, making more laboratory testing facilities available. Consumer, or self-test, devices can be used outside of a healthcare setting and without medical support. Both of these types of test are of particular importance to vulnerable and low-resource communities that do not have access to sufficient laboratory testing facilities.’
’Through our collaboration with Cytiva, our SARS-COV-2 binders will be implemented into LFA test strips to develop both professional POC-use and consumer self-tests.’
’Before a POC test can be recommended by a government, the device must be validated in the appropriate populations and settings. This prevents inadequate testing that would impede disease control efforts, and can therefore have a longer development process than standard laboratory diagnostic tests, with only a subset of tests meeting the necessary levels of accuracy.’
’To achieve this, a triple-pronged approach of more POC and consumer testing, combined with more lab-based testing is required. Avacta has quickly responded to the COVID-19 outbreak, generating multiple Affimer reagents that bind the SARS-COV-2 viral antigen within only four weeks, and working with multiple partners to address all three of these diagnostic markets.’
To me it sounds like the first LFT to be released will be a POC test administered by a healthcare professional. This will subsequently have a shorter validation and approval timescale.
A second LFT may then follow for accurate consumer testing. It sounds like the validation and approval for the higher accuracy consumer test will take longer.
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