IVDR : Clin evidence with Sensitivity & Specificity aspects

Sensitivity

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

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.

Topics covered in this Whitepaper include:

• Summary to detect Sensitivity for the claimed test/IVD/drug
• Summary to detect Specificity for claimed test/IVD/drug
• Sensitivity and Specificity in Literature search strategy, Methodology