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Disease/health condition - Meningitis
Discipline - Clinical microbiology
Gram stain
Setting:
2. Laboratory
Tiered Testing Service:
District hospital with laboratory Regional or provincial hospital with laboratory
Assay format
Microscopic examination
Information History
First added in 2020
Changed in 2024
Purpose type
Aid to diagnosis
Purpose
For the presumptive identification of pathogens (Gram +/-) and for determination of microbial morphology.
Specimen types
Urine, Body fluids (e.g., Cerebrospinal fluid, Pleural fluid, Peritoneal fluid), Exudates, Biopsy samples, Venous whole blood, Respiratory specimens (e.g., Sputum, Bronchial brushing, Bronchoalveolar lavage), Bacterial isolates
WHO prequalified or recommended products
N/A
GMDN

43587

Biological stain IVD

A chemical agent(s), dye(s) and/or solution(s) intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

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
EMDN

W0104010804

STAINS

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
Interagency list of priority medical devices for essential interventions for reproductive, maternal, newborn and child health. (2016). https://iris.who.int/bitstream/handle/10665/205490/9789241565028_eng.pdf?sequence=1 ; World Health Organization. (‎2025)‎. WHO guidelines on meningitis diagnosis, treatment and care. World Health Organization. https://iris.who.int/handle/10665/381006
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