DJ In the US the FDA came up with a warning at home tests may not detect Omicron. In the UK the story is lateral flow tests DO detect Omicron, just as good as with Delta; UK story ; [url]https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf[/url] or https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf - https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1042688/RA_Technical_Briefing_32_DRAFT_17_December_2021_2021_12_17.pdf page 14; 2.1 Performance of diagnostic lateral flow devices
UKHSA has performed an initial laboratory evaluation of the current lateral flow devices (LFDs)
for COVID-19 in current use by NHS Test and Trace. Preliminary laboratory data assess these
devices as detecting Omicron. Initial data from contrived samples indicate a comparable
sensitivity to that observed for previous strains of SARS-CoV-2 including Delta, which has been
the predominant strain in the UK from May to December 2021.
All LFDs eligible for DHSC procurement within the UK specifically detect the nucleocapsid
protein of SARS-CoV-2 using a combination of 2 or more different antibodies, each targeting a
distinct epitope. There is a significantly lower selective pressure for mutations on the
nucleocapsid protein when compared to the spike. Omicron’s nucleocapsid protein has a single
unique mutational difference from other SARS-CoV-2 variants, a deletion at aa31-33, as such
the general risk to LFD performance being impacted by Omicron was considered low.
To ensure that the sensitivity of the 5 tests that have been (or could rapidly be) deployed by
NHS Test and Trace has not been significantly reduced by Omicron the following work is
underway:
• routine and enhanced Real World Performance Monitoring of the LFDs deployed
within NHS Test and Trace
• wet lab testing with contrived samples from sequence confirmed cultures of Omicron
has been performed at Porton Down
Real World Performance Monitoring data from LFDs in Deployment
Real world data for Omicron are currently being processed and a separate technical report will
be released when analysis has been completed.
Laboratory evaluation results
Laboratory evaluation has currently been performed on 5 tests which are:
SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing 32
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• Acon Flow Flex ‘self-test’
• Innova Biotime ‘self-test and professional use test’
• Orient Gene ‘self-test’
• SureScreen ‘professional use test’
• SureScreen ‘self-test’
The evaluation is performed using dilutions of cultured virus stock in Hanks Balanced Salt
Solution (HBSS) plus mucin with 5 samples at each dilution. The dilutions provide 3
concentrations of virus in the following ranges, >1,000,000, >100,000, >10,000 viral copies per
millilitre (ml). The Omicron variant was isolated from a primary clinical sample sourced in the UK
and confirmed as being Omicron by sequencing.
In summary, the LFDs evaluated, all of which target the nucleocapsid protein, have detected the
new Omicron variant that contains 4 amino acid changes from the original viral sequence. This
does not affect their performance in the laboratory setting and we will monitor further variant
changes as they arise as part of our ongoing evaluation programme.
DJ Since at home testing is getting more important we have to know how good they are.
------------- We cannot solve our problems with the same thinking we used when we created them. ~Albert Einstein
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