Following from the Telegraph at the weekend, I have now seen the data from iAbra for their 20 second "Holographic microscopy" saliva test being trialled at Heathrow.
“we are in a pandemic, people are dying from the disease, and a company decides that it is reasonable to mislead us all to make their test look like the best thing available."
2/10
"Legally, they can probably get away with this, but there cannot be any consideration that this is morally acceptable.”
They have said my characterisation was “incredibly unfair”.
See what you think.
3/10
The product claim made by iAbra says:
Virolens®, a new screening device for COVID-19, can deliver results in just 20 seconds with 99.8% sensitivity and 96.7% specificity.
4/10
Sensitivity first
99.8% sensitivity means that if you had a 1000 people with Covid, it is positive in 998 of the people. iABRA has a different take on what sensitivity is.
Their sum which gives 99.8% is 156751940/157000000.
So what are these huge numbers?
5/10
They say they are “counts” of “virons” averaged across 3 samples. I presume they are counts of virus particles.
156751940 is the number from their machine. 157000000 is the expected number from some computation based on the replication rate (no further info given).
6/10
So the 99.8% relates to a quantity (viron count) measured in 3 artificial samples as a percentage of the value that they expected to see.
This is not an estimate of sensitivity but an assessment of measurement accuracy of their test
7/10
Specificity is worse.
Actually they call is Specitivity, so spelling is a problem too.
96.7% specificity means that of your sample of a 1000 people who are being tested for COVID but have nothing or other things, it is correctly negative in 967 of the people.
8/10
iAbra has a different take on what specificity is.
Their sum which gives 96.7% is 13232/13681
Again it is a ratio of a virus particle count to an expected value (doesn’t say how many samples).
Again it is an assessment of the measurement accuracy of their test.
9/10
If none of the clever people at iAbra know about sensitivity and specificity then they should not be working in this field.
If they do know, they are throwing sand in our eyes, which is morally indefensible.
What do you think?
10/10
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Daily Testing in school study report is out but presentation by BBC here is SPIN SPIN SPIN
The trial failed to show convincing reductions in school absence, and could not rule out large increases in Covid transmission. Sensitivity of the test was 53%.
BBC says that reduced absence by 33%, but the ITT analysis in the text says 20% reduction with 95% confidence interval from 46% reduction to a 19% increases (p=0.27). So no convincing evidence of a reduction.
Participants were first tested with LFTs – 810 positive and 1736 negative. The investigators choose to test 217 of the 1736 negatives with PCR – that’s 1 in 8. This wasn’t a random sample as they were influenced by clinical characteristics as well as the test result.
2/9
The sensitivity / specificity calculation is based on all LFT+ves and 12.5% of LFT-ves as follows:
Results from the LIVERPOOL EVENT PILOTS have been published on line and in the media. Somehow I missed these coming out. cultureliverpool.co.uk/event-research…
No official report from @dhscgov as per normal.
Seems important evidence is being delayed once again.
1/7
The bottom line is that the events were safe.
Kudos to Liverpool PH Team.
But detail is interesting to see why they were safe.
2/7
First the infection rate in Liverpool was very low when the events were held
Negative LFTs required for entry. 5/13263 positive and excluded. Same-day PCR found 4 people positive who had attended with false negative LFTs. So 5/9 were picked up by LFT – 44% missed.
3/7
What do we known about ORIENT GENE used in the Daily Contact Testing Trial by the @educationgovuk and @DHSCgovuk?
There have been claims that this test is as good as others and has been reviewed by @MHRAgovuk for use in assisted testing. This is not right
1/10
The process does not make sense.
The MHRA never review products for assisted testing as they are professional use tests, which go through the self-certification process to get a CE-IVD mark.
MHRA doesn't go near this process.
2/n
In fact ORIENT GENE is not even on the MHRA register of products which is a requirement. You can check here - both for the product and manufacturer (sorry for the messy link).