Lecture 5 Flashcards
What is Translational Research?
Turning research outcomes into tangible products and services that benefit society.
What are the key aspects of the diagnostics development process?
Safety testing in controlled settings and efficacy testing for biocompatibility.
What is preclinical evaluation determine
Efficacy, safety, and biocompatibility of biomaterials and medical devices.
What are the key aspects of preclinical analysis
Validity, reliability, repeatability, and reproducibility.
What are the stages in preclinical analysis
Intended use, technological characteristics, analytic performance characteristics, clinical performance characteristics, and labeling requirements
What is analytic specificity
The ability to measure a distinct entity without cross-reactivity.
What is linearity in analytic performance
The ability of the assay to read predictably throughout the reportable range.
What is spike and recovery
The difference between standard curve diluent and sample matrix, assessing if analyte detection is affected by matrix effects.
What are sensitivity
Sensitivity is the ability to identify ‘true’ positives
specificity in clinical performance
specificity is the ability to identify ‘true’ negatives.
: What is quality assurance in preclinical evaluation
Ensuring the reliability and accuracy of patient results, operational device prior to testing, and oversight by the POCT team.
What is internal quality control
Assessing technical performance at a specific time to ensure reliable results.
