Discipline - Anatomical pathology
Facility level:
Assay formats
Macroscopic assessment of tissue and selection of areas for microscopic examination; Microscopy of tissue sections mounted on slides and stained most commonly with haematoxylin and eosin in the first instance, then treated with a variety of special stains, selected case by case to identify pathogens and other abnormal features
Status history
First added in 2019
Changed in 2020
Purpose type
To assess tissue for infection, neoplasia, inflammatory and degenerative disorders
Specimen types
Surgical resection, Biopsy, Core biopsy, Cell block
WHO supporting documents
WHO priority medical devices for cancer management https://apps.who.int/iris/handle/10665/255262; Basic histopathology and anatomical pathology services for developing countries with variable services https://apps.who.int/iris/handle/10665/119675; WHO Guide for establishing a pathology laboratory in the context of cancer control https://www.who.int/publications/i/item/guide-for-establishing-a-pathology-laboratory-in-the-context-of-cancer-control

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.