Assessment of Analytical Performance

Question 1

Analytical performance vs diagnostic performance

Answer 1

Analytical- assess how well an instrument/method measures analyte of interest

Diagnostic- assess the ability of a test to discrimminate between a healthy and unhealthy patient (follows analytical)

Question 2

What can be investigated to assess the performance of analytical and diagnostic performance?

Answer 2

Precision
Accuracy
Specificity
Sensitivity

Question 3

Why is there a need to monitor analytical performance?

Answer 3

-Ensure reliability of data
-Quality control- stability of lab tests
-Meet requirements of regulatory bodies e.g CORU, INAB to ensure high standard of patient care
-Validation - assess performance characteristics
-Calibration - maintain accuracy
-Comparison

Question 4

How can precision be evaluated?

Answer 4

By performing
1) With-in-run precision study (intra-assay)
2) Between-run precision study (inter assay)
3) Precision profile

Can numerically define by SD and Coefficient of variation CV