RE: Professional use......advice21 Apr 2021 14:43
Innova test / Xiamen Biotime is a "for professional use only test" and rightly so given it is nasopharyngeal and nobody will willingly poke theirs or their kids brains out properly. Why do you think the real world S&S of Innova is so poor!? The MHRA basically white labelled it (hence why the one you collect from the pharmacy is in an NHS branded box) and they gave it an EUA exemption.
Hopefully with the results AVCT have produced and being AN, this should reduce the disparity between clinical and real world results. I would think this gives us a good shot at home use authorisation, but it will be for professional use only at the very start.
Here's a quote from the BMJ on it:
"Regulation grey zone
Lateral flow tests occupy a strange, deregulated grey zone. Most such “in vitro diagnostic tests” can be declared by their manufacturers as conforming to the UK Medical Device Regulations 2002. A UK approved body approves tests for higher risk infections, such as HIV, or if it is a self-testing kit. The list of high risk infections is outdated and doesn’t include SARS-CoV-2. So, manufacturers can self-declare covid-19 tests for professional use. The only stipulation is that they must be carried out by trained staff: they cannot be simply rolled out as part of a self-testing programme.
That said, they can be used for research purposes. Innova’s test was piloted for community testing in Liverpool last year. And the MHRA has issued an exemption for the Innova test so that, even though it is approved only for use by professionals, it can be sent out for self-testing under the NHS testing programme. This has highlighted the need to reform the regulations, at least in the UK."
https://www.bmj.com/content/372/bmj.n287