1/9 Where’s the evidence for the ROCHE test claims?
All I can find is the IFU document. fda.gov/media/137605/d…
@deb_cohen @phe_uk @MHRAgovuk @sarahboseley I'll summarise what I have found. Please share other studies and results if you can find them. We've searched hard.
All I can find is the IFU document. fda.gov/media/137605/d…
@deb_cohen @phe_uk @MHRAgovuk @sarahboseley I'll summarise what I have found. Please share other studies and results if you can find them. We've searched hard.
2/9 Study design
“A total of 204 samples from 69 symptomatic patients with a PCR confirmed SARS‑CoV‑2 infection were tested with the Elecsys Anti‑SARS‑CoV‑2 assay. 1 or more consecutive specimens from these patients were collected after PCR confirmation at various time points.”
“A total of 204 samples from 69 symptomatic patients with a PCR confirmed SARS‑CoV‑2 infection were tested with the Elecsys Anti‑SARS‑CoV‑2 assay. 1 or more consecutive specimens from these patients were collected after PCR confirmation at various time points.”
3/9 (that's all the detail available - standard two sentences of detail - STARD reporting guidelines clearly not applied).
4/9 Study results for sensitivity
The product claim is on the >=14 days data. So the 100% sensitivity is from 29 samples (we don’t know how many patients – they could all be from a single patient) who were tested at some time after 14 days.
The product claim is on the >=14 days data. So the 100% sensitivity is from 29 samples (we don’t know how many patients – they could all be from a single patient) who were tested at some time after 14 days.
5/9 We don’t whether they were still symptomatic and in ICU, or at home gardening. There might be a difference in their immune status. Almost certainly they would be from hospitalised patients - every study so far has been.
6/9 The confidence interval goes as low as 88.1%. The MHRA require a confidence interval with lower limit for sensitivity “96-100% in at least 200 positive samples)”. assets.publishing.service.gov.uk/government/upl… Nowhere near met!
7/9 Now @PHE say they have “confirmed 100% accuracy” at Porton Down, I cannot find this study. Please can PHE provide their evidence to support the of this test.
There are many other tests with more convincing data – but probably not such a convincing PR department.
There are many other tests with more convincing data – but probably not such a convincing PR department.
8/9 Please – it is not acceptable for data to not be fully reported and scrutinized for these tests.
It is time for companies to provide the public with proper respect and provide full honest transparent reports.
ROCHE and PHE please put all your data in the public domain.
It is time for companies to provide the public with proper respect and provide full honest transparent reports.
ROCHE and PHE please put all your data in the public domain.
9/9 We also need prospective study registration of protocols for test evaluation studies to have any confidence in the studies provided to use by industry are not selected.
