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Discipline -
Immunohematology
Direct Coombs Test
Assay format
Haemagglutination
Information History
First added in 2019
Changed in 2020
Purpose type
Aid to diagnosis, Diagnosis
Purpose
To aid in the diagnosis of the cause of immune haemolytic anaemias. To investigate a blood transfusion reaction. To diagnose haemolytic disease of the newborn (HDNB).
Specimen types
Venous whole blood
WHO prequalified or recommended products
N/A
GMDN
45811
Polyspecific antihuman globulin IVD, antibody
One or multiple immunoglobulins capable of binding to all classes of human immunoglobulin antibodies fixed to red blood cells and intended to be used in immunohaematological testing of a clinical specimen to detect red blood cell sensitization by human immunoglobulin, using an agglutination or solid-phase red blood cell adherence method.
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 2005-2024WHO supporting publications
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Technical specifications
N/A
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.
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