Agreement study

Agreement with another test is not the same as accuracy, because the comparison method may itself be wrong. Results are usually reported as agreement rates rather than sensitivity and specificity, and reviewers read them that way.

A diagnostic clinical performance study in which the diagnostic device result is compared with a result that is not from a clinical reference standard.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary