I wondrt hoe many skin types they tested it on. Scenaio - what if the calibrations are done in a nice warm room, but then tries to take a measurement wheter tje fonger is cold. i.e. the bcapilliaries are being restricted to preserve bosy heat so skin changes colour and becomes more transparent, Will this affect calibration?
The invasive meters nowadays measure the phusical interstitial fluid glucose level, but are caibrated to give reading as if for plasma blood. The HbA1c is using whole blood, so is a different calibration. I wonder whether they used different types of YSI measurement when testing. Few test laboratories carry the different adaptors and control solutions etc for doing dual testing at plasma or whole blood. At least with the ISO submission there will be a test and validation report we could read to check, but this lot seem very secretive.
invasive meters are susceptible to corruption by contaminants such as maltos, dextrose malitol etx being in the blood, so this could affect the calibrations, aeven if the new meter is immune to this intererence. However, it would be very sensitive to variations in haematocrit levels, and aslo to red blood cell count in the blood. May also be affected by lipid content as well, so agin what testing with deliberate induction of these types of interference. Will having a mobile phone in the pocket nearby affect readings?
As an engineer, these are just a few of the problem areas that could trip it up, and some of which did trip up previous competitors. We have no indicaion of what robustness testing they have done.