Discipline - Clinical microbiology
Facility level:
Assay formats
Culture on growth media plates or broth in an incubator followed by recovery of isolates and species identification (traditional manual techniques or automated equipment)
Status history
First added in 2020
Purpose type
Aid to diagnosis
Initial step in detection and identification of bacterial and fungal species for selection of appropriate antimicrobial regimens
Specimen types
Disease-appropriate specimens (e.g. urine, stool, sputum, body fluids, e.g. cerebrospinal fluid, etc.)

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.