The proportion of individuals with a negative
test result who truly do not have the target condition.
Positive predictive value
The proportion of individuals with a positive
test result who truly have the target condition.
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.
Tumour estrogen receptor status in women with
breast cancer, to identify those who will respond to endocrine therapy such as
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.
biomarkers may be used to refine criteria for disease diagnosis or staging. A
biomarker may be both prognostic and predictive.
CD4+ lymphocyte count in individuals with human
immunodeficiency virus, to identify those at elevated risk of progression to
Acquired Immunodeficiency Syndrome.
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.
In individuals with no prior history of
cardiovascular disease, low density lipoprotein to identify those with an
elevated risk of cardiovascular disease.
The condition or classification of disease the
test is intended to detect.
purpose describes the intended clinical application of the test and how the
test information will be used to improve clinical management in practice.
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.
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
When a new test replaces an existing test in the testing pathway.
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
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
replacing CK-MB as a biomarker of myocardial damage. CRP replacing
erythrocyte sedimentation rate as marker of acute inflammation.
peptides before echocardiography for congestive heart failure
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