Risks of false positives in school testing with Innova
Innova testing of asymptomatics in England has very low rates of test positivity at the moment (0.3%). The lower this figure gets, the more likely a positive result is to be a false positive than a true positive.
1/7
This rate is in health care workers and others getting community testing – you will expect rates in school testing to be lower as children have been locked down.
What are the chances of a positive result being a false positive?
Best data we have are from University testing
2/7
Kudos to @PubHealthScot for looking at this with University students and clearly and fully reporting their findings.
Report from 27th Jan shows key data for Uni testing in Nov/Dec.
3/7
Data up to 17th Dec found 106 of 49904 positive (0.2%).
The majority (must be around 70) of which were at Dundee university. PCR testing of positives here showed a very high false positive rate and it was determined that the University had a received flawed batch.
4/7
From the other unis data to the 19th Dec found 35 LFT positives and 45505 negatives (0.1% positivity rate)
Of the 35 positives, 25 were confirmed positive by PCR, 10 were negative on PCR. So positive predictive value is about 70% (95% confidence interval from 55% to 85%).
5/7
So without PCR confirmation ...
... Dundee would wrongly think it had an outbreak
... about one third of those isolating (don't forget their contacts as well) would be doing so unnecessarily.
6/7
Suggests that PCR confirmation for schools testing is absolutely essential to ensure only real cases and their contacts are isolated – why is it not organised?
(also you might start asking questions as to when levels are too low for this testing to be worthwhile at all).
7/7
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What is the evidence supporting the Government’s claims that Innova LFT detects infectious cases?
There are no real studies at all which directly show how well Innova +ve detects infectious people and Innova -ve indicates non-infectious people.
No direct data at all.
1/19
The data come from studies of PCR with inferences made by linking PCR proxy “viral load” Ct values to the viral load levels we know that Innova detects.
Ct values are not standardised and depend on how much biological matter on a swab. They have high measurement error
2/19
Evidence on infectiousness comes from studies linking Ct values with rates of (a) secondary cases and (b) the ability to culture the virus. Neither are perfect – but are the best we can do. They will both most likely underestimate infectiousness.
@TomChivers has taken on the challenge of trying to understand the disagreements over LFTs. We had a good chat, but unfortunately the final article mispresents some of my views. I explain more below.
Context matters … I am aware that people outside the UK are reading my tweets and papers, and influencing their thinking about lateral flow testing. It’s really important that you understand the context I am writing from, and why it probably is different where you are.
1/11
The situation and issues in the UK (particularly in England), is almost certainly unlike where you are. The UK Government are unique in many ways and that is impacting on how tests are being used. (As a Brit I am also prone to understatement and being overpolite).
2/11
Our Government have staked their reputation on the Moonshot idea “to get our lives back to normal” using LFTs before there was evidence to see whether it would work. It doesn’t make sense to decide policy before evaluating the technology. Decision-making is now politicised.
3/11
What is the explanation behind this from @educationgovuk? Why has the @MHRAgovuk said DfE does not need regulatory approval for daily “assisted testing” given it does not approve daily “self testing” of contacts of infected cases in schools?
Daily self-testing of contacts was not approved because MHRA considered that the test misses too many cases, allowing infected and infectious individuals to remain in class. The MHRA would have come to this decision based on a forensic and balanced assessment of the evidence.
Hopefully somebody can help answer why this does not also apply to “assisted testing”. I can think of three different explanations. There may be more.
Great summary and we really need to take the toxicity out of this. Agree with >95% of what is here. Thx for taking time to do this. The big challenge is how we make quick progress without being able to get a ref std for infectiousness. Cluster RCTs great but hard to do.
Part of my 5% disagreement arises in whether we are making a mistake in trying to force “infectiousness” into the test accuracy paradigm, or whether we could do better considering it in a different way. It is a probabilistic rather than binary concept which causes the problem.
We can classify people as more or less likely to infect others, but I don’t think we will ever successfully put people into two groups of those who do or do not infect somebody else from a test. That is unlike our ability to say that people do or not have detectable virus.
The MHRA has now confirmed to Schools Week it has “not issued an Exceptional Use Authorisation for that self-test device for ‘serial testing’ for school pupils who have been exposed to a confirmed positive COVID case that would enable them to attend school as normal”.
MHRA: “continues to advise that close contacts of positive cases identified using the self test device continue to self-isolate in line with current guidelines. Discussions with Test and Trace regarding any future exceptional use cases are ongoing.”