EU Directive - Antigen Tests28 Oct 2021 21:14
Good post by Energyshares on Avacta BB which is relevant to EU Antigen tests / interest to this BB
Pasted /posted full post below
New EU directive looking for best tests
From 26 May 2022, the Directive will be replaced by Regulation (EU) 2017/7465. The Regulation will strengthen the requirements for the evidence on performance of the device and introduce a thorough assessment of COVID- 19 tests, including RADTs, by notified bodies.
Page 15 conclusions:
“If tests are to be used to certify recovery from infection, higher specificity tests (>98%) are preferred”
There are currently many RADTs on the EU/EEA market, which vary in their performance characteristics. Independent evaluations have shown that RADTs have variable and lower sensitivity compared to NAAT tests but have a high specificity, often comparable to NAATs. The currently available data show that RADTs sensitivity is high (and can be equivalent to NAAT) in situations when the time of sampling is up to five days after symptom onset, i.e. during the infectious period. ECDC agrees with the minimum performance criteria set by WHO (sensitivity =80% and specificity =97%) and recommends use of tests that have a higher sensitivity of =90% and minimum specificity of >98%, in line with the HSC TWG list. Some of the available tests on the market are included in the HSC list of mutually recognised tests in the EU/EEA and meet the agreed clinical performance criteria. If tests are to be used to certify recovery from infection, higher specificity tests (>98%) are preferred.
RIP PCR looks like best performing tests will replace PCR.
https://www.ecdc.europa.eu/sites/default/files/documents/Options-for-the-use-of-rapid-antigen-tests-for-COVID-19-first-update.pdf