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
