Clinical performance

Ability of a biomarker to conform to predefined clinical specifications in detecting patients with a particular clinical condition or in a physiological state.

Example

  • Diagnostic test: In patients presented to emergency with chest pain and low to intermediate likelihood for ACS, the hs-cTnT assay was compared with a conventional cTnT method and CT angiography as the gold standard for diagnosing ACS.  At the optimal hs-cTnT cut point of 8.62ng/L, sensitivity for ACS was 76% and specificity was 78%, and hs-cTnT above the 99th percentile strongly predicted ACS. Compared with the conventional cTnT method, hsTnT detected 27% more ACS cases.
  • Prognostic test: In elderly patients presenting to primary care with symptoms of heart failure the risk for cardiovascular mortality (adjusted for age, sex, impaired estimated glomerular filtration rate, and anaemia) increased 2.5-fold with a plasma NT-proBNP concentration >507 ng/L; 2-fold with hs-cTnT >99th percentile; 3-fold when both biomarkers were elevated.

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