Covid-19: Antibody test that claims to be 99% accurate is certified by EU
BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m1742 (Published 29 April 2020) Cite this as: BMJ 2020;369:m1742Read our latest coverage of the coronavirus pandemic
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Dear Editor
Thank you Dr Höser.
Glad to understand.
Now I can put a question to Mr Matt Hancock.
To what degree in percentage terms, is your coronavirus POSITIVE test reliable?
For example: 99%. 60%. 1%.
And if your test result is NEGATIVE?
Do you retest? And retest once? Twice? Thrice?
Another question: to Abbott Laboratories
Does a positive result mean that:
The patient has had an infection?
The patient is now immune to Covid 19?
If immune, how long will immunity last?
Thank you.
Dr JK Anand
Retired public health physician
Competing interests: Might suffer from Covid 19 one day.
Dear Editor
As far as I know, the title of the CE certificate for the product is awarded by the manufacturer himself and not by EU. Using this sign the manufacturer states, that the product fulfils the underlying - but very general - EU regulations. The EU on the other side is not CE-certifying anything, especially not for a specific product or a specific property of the product. There is no EU-testing institution for that purpose.
The underlying CE-regulations are the least specific definitions a product may have. They do not prove any special quality check of the product outside of the manufacturer, no specific property and no objective third party quality assurance. CE certificates (especially without a 4 digit identification) issued by the manufacturers themselves are not worth mentioning in a scientific journal.
Any other review of Abbott's in-house results, particularly by independent and scientific institutions, is worth much more than CE certification. Unfortunately, this option is not cited in the article and only the CE mark is mentioned. I very much hope that the in-house results can be confirmed, which is not included in the publication. The CE mark is no substitute for this part.
From this perspective, the title of the publication appears to be irritating.
Best regards
C. Höser
Competing interests: No competing interests
Dear Editor
Antibody Policy
Thu 30 Apr 2020 - On the day the EU announces an official antibody test - https://www.bmj.com/content/369/bmj.m1742 – manufactured by Abbott partly in the UK, Reuters quotes “So far, British officials have not found an antibody test that works reliably enough to roll out on a large scale.” In the same article the British Medical Journal quotes Abbott saying there are 250 machines in the UK capable of 100-200 per hour. Is that somewhere between 600,000 and 1.2 million per day?
Compare this with the target Matt Hancock has set for today’s infection testing.
If we are on the eve of permitting less essential workers in less vulnerable groups to return to work why can’t we use the opportunity to antibody test them when they start, issue a maybe-immune passport and re-test them a fortnight later for infection and antibodies?
That gives the authorities data on test repeatability and eventually on antibody associated immunity.
That is something they urgently need to rationally plan relaxation of self-isolation measures. A credible outcome is longer term passports, and a more general return to work.
Abbott’s test claims 99% reliability, UK health demands 98% reliability. That should be close enough.
To repeat, if we can let them out with no test and no documentation, what is the harm in using them to test the testing?
It is not impossible logistically. Every GP can do swabs and check vulnerability. All of them can tie a QR wristband on each swab-ee. There is enough IT capability to match antibody result to QR code. There will soon be a contact tracing app that could be extended to wristband validity and re-swab appoinments. Not to mention research projects that would gobble that data with glee. Research projects that would finally get some long overdue solid evidence for shaping public policy on the pandemic.
Elliott Roper elliott@yrl.co.uk
Competing interests: No competing interests
Re: Covid-19: Antibody test that claims to be 99% accurate is certified by EU
Dear Editor,
99% true positive sounds great with the expense of true negative. As I (a HCP) had the "test" for antibodies coming back negative, I would have bet my bottom dollar that I had the bug in late Jan with all the symptoms, I was truly surprised.
Given the study was done before April, I guess their (the manufacturers') assessment of people with or without signs of COVID was as scientific as my approach.
Do you have any advancement or progress on this or any other study?
Kevin
Competing interests: No competing interests