“The current trial is
not testing ResappDx to see if it agrees with a clinician.”
With respect TT I think you have got this wrong and have been inadvertently misleading people on this forum for weeks.
The trial is in fact testing agreement. It is plainly written as such in the trial registration.
Second you are mistaken that there is a gold standard comparator that will be used to determine who was more accurate.
There will not be. CT scanning will only be used for a small number of cases because it is unethical to gives kids a dose of radiation simply for research.
The company told you this in the announcement where it clarified that agreement statistics are being used (as opposed to sensitivity / specificity) precisely because there is no gold standard reference test in the trial.
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