CLSI EP24-A2

Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition

Body: CLSI
Number: CLSI EP24-A2
FDA recognition no.: 7-234

Scope

Partial recognition. The following part(s) of the standard is (are) not recognized: Section 6.1.2.2, 6.1.3, and 7.1.1 related to selection of the cut-off(s) in the studies for evaluation of clinical performance.

Scope source: FDA 认可共识标准库

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