IVDR : Clin evidence with Sensitivity & Specificity aspects


Sensitivity measures how often a test/device correctly generates a positive result for people who have the condition that’s being tested for (also called positive control). A test/device that’s highly sensitive will flag almost everyone who has the disease and not generate many false-negative results.


Specificity measures a test’s/device’s ability to correctly generate a negative result for people who don’t have the condition that are being tested for (also called negative control). A high-specificity test will correctly rule out almost everyone who doesn’t have the disease and won’t generate any false-positive results.