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Disease/health condition - Anaemia, Sickle cell disease (SCD), Septicaemia, Cancer
Discipline - Haematology
Complete blood count (CBC)
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Automated haematology analyser
Information History
First added in 2018
Changed in 2024
Purpose type
Determination of physiological status, Screening, Aid to diagnosis, Diagnosis, Montoring
Purpose
To evaluate overall health and to detect a wide range of disorders, including anaemia; infections; leukaemias; red blood cells (RBC), white blood cells (WBC) and platelets abnormalities; and primary immune disorders. To diagnose and monitor chemotherapy-associated myelotoxicity. To screen potential blood donors.
Specimen types
Capillary whole blood, Venous whole blood
WHO prequalified or recommended products
N/A
GMDN

55854

Full blood count IVD, kit, cell count

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters* in a clinical specimen using a manual, semi-automated or automated cell count method. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.

The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024
* also known as complete blood count (CBC)
EMDN

W0103010103

COMPLETE CELL COUNT

The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
WHO supporting publications
World Health Organization. (‎2017)‎. WHO list of priority medical devices for cancer management. World Health Organization. https://iris.who.int/handle/10665/255262 ; WHO SICKLE package of interventions for sickle-cell disease management: strategic guidance framework: Module 1. Brazzaville: WHO African Region, 2024. https://www.afro.who.int/sites/default/files/2024-06/WHO%20SICKLE_Module_3.pdf
Technical specifications
N/A
Related Medical Devices in MeDevIS
SAGE IVD recommended including this test in the EDL on the basis of the scientific validity of the analyte. It was recognized that the test is a foundational IVD test and is included in clinical guidelines.
N/A
The inclusion of this test was based on WHO guidelines and/or technical documents that include recommendations for the use of this test.
N/A