RE: AbC 19 Rapid Test - MHRA Targets Met3 Oct 2020 16:01
UK-RTC AbC-19 lateral flow immunoassay shows a sensitivity of 97.70% (95.72%-99.34%)
and specificity of 100% (100.00-100.00%).
MHRA requires:
Clinical sensitivity
Greater than 98% (with 95% confidence intervals of 96-100%) on specimens collected 20 days or more after the appearance of first symptoms.
These statistics rely on testing of at least 200 confirmed positive cases.
Clinical specificity
Greater than 98% (within 95% confidence intervals 96-100%)
These statistics rely on testing of at least 200 confirmed negative cases or from testing of specimens collected at least 6 months before the known appearance of the virus.
Looks like we fall short with the sensitivity. But the MHRA requirements are so convoluted it's difficult to know whether this is a pass or not. But whether it is or it isn't, it's pretty obvious that we have to get some sort of rapid testing in place if we want to open up stadiums, hospitality, and theatres.
The RTC rapid test is the best one out there. MHRA will have to make the decision whether to pass this and put up with a few false positives or negatives, or continue with the current three/four day wait for results. It's a no brainer, the country needs rapid testing now. You can always test two or three times to eliminate the chance of a false positive or negative.