Download

Disease/health condition - Meningitis
Meningitis nucleic acid amplification test multiplex panel
Setting:
2. Laboratory
Tiered Testing Service:
Regional or provincial hospital with laboratory
Assay format
NAAT
Information History
First added in 2024
Purpose type
Aid to diagnosis
Purpose
To aid in the diagnosis of acute meningitis
Specimen types
Cerebrospinal fluid
WHO prequalified or recommended products
N/A
GMDN

61043

Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of pathogens associated with meningitis, in a clinical specimen, using a nucleic acid technique (NAT). Pathogens detected may include but are not limited to Streptococcus meningitidis, Neisseria meningitidis, Haemophilus influenzae, adenovirus, enterovirus, cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2), varicella-zoster virus (VZV), and Mumps virus.

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

W0105070505

MENINGITIS / ENCEPHALITIS INFECTION - MULTIPLEX NA REAGENTS

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. (‎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 and the availability of WHO guidelines and technical reports, including recommendations for the use of this test. The selection of disease specific tests for the EDL also took into account relevant priority diseases for WHO such as NCDs including DM, CVD and cancer, HIV infection, malaria, NTDs, STIs, tuberculosis, viral hepatitis B and C, among others.
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.
In 2022 SAGE IVD reviewed an application for meningitis/encephalitis multiplex polymerase chain reaction panel which was rejected for listing in EDL 4. However, in 2025 WHO published the first comprehensive WHO clinical guidelines on meningitis diagnosis, treatment and care (available at: https://iris.who.int/handle/10665/381006), in this guideline WHO strongly recommends PCR-based molecular tests in individuals with suspected acute meningitis, therefore, the 2022 EDL application becomes relevant and it is available at World Health Organization. (‎2023)‎. The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (‎including the fourth WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/373322