The biosure home antibody test26 Aug 2021 21:50
Being the curious type, been wondering how this company can retail the device to home addresses. Colin King has told us that MHRA authorisation only can happen for self/home test if the DHSC asks for it. And that without such authorisation, it can not be sold as a self-test in the UK ?
The biosure website is very clear that they will deliver one-off tests of the biosure product, but need to talk to you first if you want to by the RTC-19, for which they are also an outlet, indicating that they are happy to ship one to individuals but not the other. Their website shows the MHRA logo, and given how professional everything else appears, I get the impression they would not be showing it if they don't have it, HOWEVER they do have a home HIV test using the same items, and that's been around for a long time, so possibly the MHRA logo relates to that.
After a bit of sniffing, I was led to believe that one avenue that might be used was to ship from Northern Ireland. Since Brexit, N.I. has some medical regulatory vagueness, it falls under the EU reg for some stuff, and the test is CE approved in Europe. So was N.I. being used ?
I ordered one to find out. Ordered using tracking so I could see where it came from. Tracking shows that it was depsatched from "home counties North MC" so they are being despatched from England. So none the wiser how they can sell within the uk.
The packing does not show MHRA, it shows CE, confirms that it was made in the UK, and that biosure has a 2021 queens award for innovation. Expires Oct 2022.
Test was extremely easy to use, it would be hard to mess it up.
But here's the kicker, I came back negative for antibodies. The control line showed within a minute. I'm doubled jabbed, with my 2nd AZ jab in mid-May. So there's one of 2 possibilities. Either I'm one of the very very few that did not have an antibody reaction to the AZ vaccine, or the test failed to pick up my antibodies.
images of the test and my result are:-
https://imgur.com/a/5YFmxVC