Glossary of terms (terminology and key principles).

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In vitro medical assay

A measurement procedure undertaken on a biological specimen which measures the quantity of the biomarker (see below) intended to be measured; i.e. the measurand.

  • Two-site immunoenzymatic (“sandwich”) assay using electrochemiluminescence detection for cardiac Troponin (cTn) measurement
  • Cation exchange chromatography or boronate affinity chromatography or by a latex agglutination immunoassay measured HbA1c 

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In vitro medical test

In vitro medical tests or testing strategies utilize laboratory assays of biomarkers in a specific clinical context and for a specific clinical purpose (see below), in a specific patient population.

  • Serial cTn testing for diagnosing acute coronary syndrome (ACS) in patients with symptoms of acute chest pain.
  • HbA1c as a monitoring test to assess treatment effect in type 1 or type 2 diabetic patients.
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