Glossary


Glossary of terms (terminology and key principles).

Browse the glossary using this index

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M

Mapping template Step 1

Mapping template - STEP 1

Entry link: Mapping template Step 1

Mapping template Step 3

Mapping template Step 3

Entry link: Mapping template Step 3

N

Negative predictive value

The proportion of individuals with a negative test result who truly do not have the target condition.

Entry link: Negative predictive value

P

Positive predictive value

The proportion of individuals with a positive test result who truly have the target condition.

Entry link: Positive predictive value

Predictive biomarker

In individuals with a confirmed diagnosis, the presence of a predictive biomarker is used to identify individuals who are more likely to experience a favorable or unfavorable effect from a specific intervention or exposure than individuals where the biomarker is absent.  Predictive biomarkers may be used to refine criteria for disease classification.

Example

  • Tumour estrogen receptor status in women with breast cancer, to identify those who will respond to endocrine therapy such as tamoxifen.
Entry link: Predictive biomarker

Prognostic biomarker

In individuals with a confirmed diagnosis, the presence or level of a prognostic biomarker is used to identify the likelihood of a clinical event, disease recurrence or progression, independent of the effects of a specific intervention. 

Prognostic biomarkers may be used to refine criteria for disease diagnosis or staging. A biomarker may be both prognostic and predictive.


Example

  • CD4+ lymphocyte count in individuals with human immunodeficiency virus, to identify those at elevated risk of progression to Acquired Immunodeficiency Syndrome.
Entry link: Prognostic biomarker

R

Risk biomarker

In an individual without clinically apparent disease, a risk biomarker is used to indicate the potential for developing a disease or sensitivity to an exposure.


Example

  • In individuals with no prior history of cardiovascular disease, low density lipoprotein to identify those with an elevated risk of cardiovascular disease.
Entry link: Risk biomarker

T

Target population

The condition or classification of disease the test is intended to detect.

Entry link: Target population

Test purpose

Test purpose describes the intended clinical application of the test and how the test information will be used to improve clinical management in practice.


Example:

  • HbA1c as a diagnostic marker of diabetes mellitus.
  • HbA1c as a monitoring test to assess diabetes control.
  • hs-cTn for diagnosing ACS.
  • hs-cTn as a prognostic marker for cardiovascular morbidity and mortality.





Entry link: Test purpose

Test role

Test role describes how the test, used for a specific clinical purpose, will be positioned to alter the existing clinical pathway in a specific condition or target population:

Replacement: When a new test replaces an existing test in the testing pathway.

Triage: When the new test is used before the existing test or testing pathway, and only patients with a particular result on the triage test continue on the testing pathway.

Add-on: When a new test is added to the existing testing pathway, either to help interpreting results of analyses when establishing a diagnosis or to assist patient management.

Example

  • Replacement: cTn-s replacing CK-MB as a biomarker of myocardial damage. CRP replacing erythrocyte sedimentation rate as marker of acute inflammation.
  • Triage: Natriuretic peptides before echocardiography for congestive heart failure
  • Add-on: Immunofixation for typing is added when monoclonal gammopathy is found on serum protein electrophoresis. HbA1c monitoring together with self-monitoring of blood glucose in managing Type 1 diabetes patients






Entry link: Test role


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