Validating high complexity lab test methods who is crista flanagan dating
Once a sufficient number of specimens are collected for each fluid type, the recommendation is to analyze all fluid specimens for every test being validated.
The Importance of Body Fluid Chemistries A review of the variety of patient specimens that are submitted to the clinical laboratory illustrates that several major fluid types do not fall into conventional specimen categories.
If the laboratory performs its own assay validation without relying on method performance specifications from the manufacturer or published literature, it should include accuracy, precision, method comparison, limit of detection (sensitivity), interfering substances (specificity), and reference interval studies per the CAP checklist.
Precision and Sensitivity During the specimen collection phase, the laboratory should research how the specific analytes measured are used clinically.
Strategies for Validation The approach to validation of body fluid specimen testing for chemistry analysis is similar to that of other validations performed in the laboratory.
outlines an example of a typical workflow required to validate a series of body fluid tests.