2A Test 60 spiked saliva samples (n=15x4 dilutions)+71 -ve samples
2B Test against seasonal coronaviruses
3 Lab study of 1000 negatives and 200 positives sourced by Oxford University Hospitals. -ves fresh (<48hr) saliva samples +ves frozen
“Phase 3 findings will be reported to the Oversight Group, with DHSC and ministers using this information and any recommendations to inform potential purchasing decisions.”
Little detail is public – full results below - criteria for “pass” and “fail” for Phase 3 not stated
Its rather hard to find any criterion on the STARD checklist that this meets. This level of reporting is nowhere near the hopes of @RoyalStatSoc call for transparency. @DHSCgovuk@PHE_uk can you release full reports please as you have done before?
This is a lab based study on pre-selected samples, thus will only provide estimates akin to analytical accuracy, not estimates of diagnostic accuracy in the settings where they will be applied.
Boris described these as “tests of whether you are infectious” last night. There is no mention of infectiousness in the protocol – they are assessed as tests of infection not infectiousness.
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and I presume was on Boris’s list of the tests last night.
We are updating our Cochrane review and have been through our searches. There are no pre-prints or published studies of this test.
There are 2 studies – 1 from the company Instructions for Use (IFU) and 1 from PHE Porton Down.
Test is made by Xiamen Biotime Biotech in China.
Quick Critical appraisal of PHE Porton Down study:
1)Is the study relevant? Can’t tell.
2)What do the results mean? Can’t tell.
3)Should we believe the results? Can’t tell.
(please give us the full report!!!)
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”.
We have published our next Cochrane review of Covid-19 tests:
Rapid, point‐of‐care antigen and molecular‐based tests for diagnosis of SARS‐CoV‐2 infection - Dinnes, J - 2020 | Cochrane Library cochranelibrary.com/cdsr/doi/10.10…
Includes pre-prints and published studies available up to the end of May. We found 18 study cohorts with 3198 unique samples, of which 1775 had confirmed SARS‐CoV‐2 infection.
Due to the importance of these tests we currently updating to end of July and will republish in weeks.
Most of the data included here are from remnant sample studies, didn't use the tests according to their instructions, and were shockingly poor in other ways.