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

Author(s):
Lord, S.J.; Horvath, A.R.; Sandberg, S.; Monaghan, P.J.; Cobbaert, C.M. (0000-0003-3565-1404); Reim, M.; Tolios, A.; Mueller, R.; Bossuyt, P.M.; EFLM Working Grp Test Evaluation
Published
2025
Publication type
Article / Letter to editor
In vitro diagnosticsbiomarkersclinical performanceclinical evidenceregulatory approval
Date issued
2025-02-04
Language
English
Publisher
Taylor & Francis
Is part of
Critical Reviews in Clinical Laboratory Sciences (2025), Vol. 62, no. 3, p. 182-197
hdl
1887/4288973
doi
10.1080/10408363.2025.2453148