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Discipline - Clinical microbiology
Genus and species identification of bacteria and fungi
Facility level:
Assay formats
Blood culture bottle in an incubator followed by recovery of isolates (traditional manual techniques or automated equipment)
Status history
First added in 2020
Purpose type
Aid to diagnosis
Purpose
To identify the genus or species of bacteria or fungi from microbial isolates
Specimen types
Microbial isolates

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.