Quick Review Cards for Medical Laboratory Science

Test Performance Specifications

and Verificationcontinued

PARAMETER EXPLANATION VERIFICATION

5. Analytical sensitivity


6. Analytical specificity

Determined by manufacturer. For unmodified

FDA-approved tests, verification isn’t required.

Determined by manufacturer. For unmodified

FDA-approved tests, verification isn’t required.

Same as detection limit. Lowest concentration of

substance that can be detected by test method.

↑sensitivity means ↓false negs. Desirable in

screening tests.

Ability of method to measure only analyte it’s sup-

posed to measure & not other related substances.

↑specificity means ↓false pos, ↓cross-reactivity.

Desirable in confirmatory tests.

Laboratory Operations Review 57