Clinical performance is the third pillar of performance evaluation and describes the ability of a test to provide results that correlate with a specific clinical condition or a physiological or pathological process or condition.
Demonstration of clinical performance can be provided from one or a combination of the following sources:
- Studies on clinical performance
- The scientific literature
- Published experience from routine diagnostic tests
Together with data on scientific validity and analytical performance, the data on clinical performance flows into the clinical performance evaluation. Here, too, Biomex has the appropriate know-how and supports manufacturers in carrying out clinical performance evaluation studies.
Biomex GmbH is happy to support IVD manufacturers in providing confirmation of clinical performance in the following areas:
- Common Technical Specifications/Common Specifications (CTS/CS)
- Near-Patient Testing (NPT)
- Lay studies