Discipline - Haematology
Prothrombin time and international normalized ratio (PT/INR)
Facility level:
Assay formats
Hand-held or automated coagulation analyser
Status history
First added in 2019
Changed in 2020
Purpose type
Diagnosis, Monitoring
To detect or diagnose a bleeding disorder or thrombotic disorder (prothrombin time (PT)); To monitor performance of anticoagulant medications (International normalized ratio (INR)) Note: Result time sensitive for emergency and critical care
Specimen types
Citrate plasma

Summary of SAGE IVD recommendation

General In vitro diagnostics tests are the general core and routine laboratory tests for clinical chemistry, haematology, blood transfusion, microbiology (virology, bacteriology, parasitology and mycology) and histopathology. These tests were selected on the basis of the scientific validity of an analyte, i.e. the association between an analyte and a clinical condition or physiological state; and clinical utility. Many of these tests are required for effective management of patients and have already been described in WHO publications.

Details of submission from 2020

The inclusion of this entry was based on WHO guidelines and technical reports that include recommendations for the appropriate IVDs.