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Analytical performance Ability of an in vitro medical assay to conform to predefined quality specifications (e.g. as defined by the Stockholm Conference hierarchy or in clinical guidelines)  Example Universal definition of myocardial infarction recommends that high sensitivity Tn assays must have acceptable imprecision, i.e. ≤ 10% CV, at the 99th percentile of normal.

Keyword(s): Analytical validityTechnical efficacy

Biomarker A characteristic that is an indicator of normal biological or pathogenic processes, or pharmacologic responses to a therapeutic intervention. Examples cTn-s are biomarkers of cardiac diseases associated with myocardial ischemia and necrosis HbA1c is a biomarker of altered glycosylation in hyperglycaemic states, such as diabetes mellitus

Keyword(s): Biological marker

Broader impact Consequences of testing beyond clinical effectiveness and cost-effectiveness (e.g. acceptability, social, psychological, legal, ethical, societal, organizational consequences and other aspects).  Example Psychological impact of genetic testing for familial hypercholesterolemia: An RCT in a population previously aware of their hypercholesterolemia found that finding a mutation by genetic testing did not reduce patients' perceptions of control over the disease and adherence to risk-reducing behaviors, but did affect their perceptions of how control is most effectively achieved.

Keyword(s): Feasibility

Clinical effectiveness Ability of a test to improve health outcomes that are relevant to the individual patient. Example The clinical effectiveness of BNP testing for diagnosis of heart failure in patients presenting to emergency with acute dyspnea were investigated in RCTs that compared the addition of BNP testing with standard investigations alone followed by routine care. A meta-analysis of these RCTs reported that addition of BNP testing decreased length of hospital stay by ~1 day; possibly reduced admission rates, but did not affect 30-day mortality rates.

Keyword(s): Clinical utilityClinical usefulness

Clinical pathway A description of typical processes of care in managing a specific condition in a specific group of patients. Example Clinical pathways by NICE in the UK

Keyword(s): Clinical algorithmCare pathwayCritical pathwayCare mapGuideline

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.

Keyword(s): Clinical validityTest performancePerformance characteristicsOperating characteristicsTest accuracyDiagnostic accuracyDiagnostic accuracy efficacyTest efficacy

Cost effectiveness A cost-effectiveness analysis compares the changes in costs and in health effects of introducing a test, to assess the extent to which the test can be regarded as providing value for money. Example Point of care testing (PoCT) in general practice: A cost-effectiveness analysis based on an RCT of nearly 5,000 patients followed up for 18 months in Australian general practices compared the incremental costs and health outcomes associated with a clinical strategy of PoCT for INR, HbA1c, lipids, and albumin:creatinine ratio (ACR) to those of pathology laboratory testing. Under base-case assumptions, PoCT was more cost-effective and effective for ACR than standard pathology. For HbA1c, POCT was more expensive but also more effective than standard pathology with an incremental cost-effectiveness ratio of $40 per patient maintained in the therapeutic range, while INR was more costly but less effective and therefore not cost-effective.

Keyword(s): Cost Efficiency

Health outcome A characteristic or event that can be measured to assess the impact of clinical care on an individual’s health. It describes or reflects how an individual feels, functions or survives. Example Blood pressure, stroke, physical function, quality of life, death.

Keyword(s): Outcome measureOutcomeOutcomesClinical outcomes

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. Examples 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

Keyword(s): In vitro diagnostic medical deviceLaboratory assayMeasurement procedure

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. Example 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.

Keyword(s): Medical testTesting strategy

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