1. Assessing the value of diagnostic tests: a framework for designing and evaluating trials;Ferrante di Ruffano;BMJ,2012
2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing directive 98/79/EC and Commission Decision 2010/227/EU;Offic J Eur Union,2017
3. Clinical trials in development and marketing of medical devices;Becker,2006
4. The architecture of diagnostic research;Sackett;BMJ,2002
5. A framework for clinical evaluation of diagnostic technologies;Guyatt;Can Med Assoc J,1986