Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of in vitro diagnostic (IVD) regulation
Lord S J, Horvath R, Sandberg S, Monaghan P J, Cobbaert C M, Reim M, Tolios A, Mueller R, Bossuyton P M, on behalf of the
EFLM Working Group on Test Evaluation
Critical Reviews in Clinical Laboratory Sciences 2025
You can read it here.
