I had occasion to review a revision to the CLSI guidance document EP19. However, when I downloaded the document, out popped a revision to EP21 instead.
What I had pushed for in the revision of EP21 – before I got kicked off the subcommittee – is gone. EP21 is about total error, which in practice relates to the error that is allowed to occur in the experiment. If you have a bunch of regulatory affairs people on the subcommittee, you restrict the allowable error sources and things look great but don’t necessarily reflect reality.
In the glucose meter POCT world, the CLSI version of a glucose meter standard had the above and other limitations, about which I ranted. And then the FDA came out with its own draft guidance and said – fuhgetaboutit – meaning don’t use the CLSI standard, we’ve come out with our own standard. I talked about this before but note that the FDA draft guidance wants to see experiments performed in the hands of the intended users – unlike the revision of EP21 which goes out of its way to exclude this error source.
So it’s been so long fighting this battle, I have to say I’m losing interest.